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On Dec. 1, 2017, the U.S. Food and Drug Administration (FDA) approved Ogivri (chemical name: trastuzumab-dkst), a biosimilar for Herceptin (chemical name: trastuzumab), to treat people with HER2-positive breast cancer or HER2-positive metastatic stomach cancer.

Read the FDA press announcement.

Ogivri was previously known as MYL-1401O and is made by Mylan-Biocon.

Herceptin (chemical name: trastuzumab) is a monoclonal antibody, a targeted therapy medicine used to treat HER2-positive breast cancers. Herceptin is what’s called a “biologic” drug. This means that it is made from living organisms, in this case a protein from a mouse cell. A monoclonal antibody is a type of protein made in the lab that can bind to substances in the body, including cancer cells. Each monoclonal antibody is made so that it binds only to one substance. Herceptin binds to the HER2 receptor proteins in cancer cells.

Because they are made from living organisms, biologic drugs are much more complex to make than conventional drugs that are made from a mixture of chemicals. The chemical structure of conventional drugs can be easily identified and duplicated, which is why there are so many generic drugs on the market.

A biosimilar is a new type of biologic drug. A biosimilar is almost identical to a biologic drug that is already approved by the FDA (or similar organizations in other countries). It can help to think of a biosimilar as a generic version of a biologic drug, though that comparison isn’t completely accurate.

The makers of biosimilars don’t have access to the original cell lines used to make the biologic drug. They also don’t have access to the exact purification process or other manufacturing steps used by the makers of the biologic drug.

Biologic drugs can be very sensitive to changes in the manufacturing process. If one small step is done differently, the biosimilar may have very different effects than the original biologic drug.

So, the FDA requires that any biosimilar drug go through the same rigorous clinical trials that original biologic drugs do before the agency will approve the biosimilar.

The FDA’s approval of Ogivri is based on review of evidence that included extensive studies on the drug’s structure and function, animal study data, studies on how the drug is absorbed and metabolized by the human body, studies on how the drug affects people, and other clinical safety and effectiveness data that demonstrate Ogivri is biosimilar to Herceptin.

The FDA emphasized that Ogivri has been approved as a biosimilar, not as a product that is interchangeable with Herceptin.

The approval is based on research showing that Ogivri is as effective and as safe as Herceptin.

Like Herceptin, Ogivri can cause side effects, some of them severe. Common side effects include:

  • low white blood cell counts
  • peripheral neuropathy
  • diarrhea

Less common but more severe side effects of Ogivri include heart and lung damage.

Hope Rugo, M.D., professor of medicine at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center and member of the Breastcancer.org Professional Advisory Board, has conducted research on Ogivri. In an interview last year, she said that FDA approval of Ogivri could allow more access to treatment for women diagnosed with HER2-positive breast cancer.

“Lack of access is not a major issue in the United States,” she said, “because most patients have insurance that covers trastuzumab. I’ve not seen a situation where it wasn’t covered for a standard indication.”

Still, in other countries, cost can mean that some women don’t receive the treatment.

“It is expected that having biosimilars will reduce costs -- by some amount -- for these agents around the world,” Dr. Rugo said.

Right now, it’s not clear when Ogivri will be available in the United States or how much Ogivri will cost. Roche, the company that makes Herceptin, recently filed a lawsuit against Pfizer over another Herceptin biosimilar.

Stayed tuned to Breastcancer.org for the latest information on Ogivri and other biosimilar drugs for breast cancer.

For more information on biosimilars, read a Breastcancer.org blog on biosimilars, listen to our podcast with Philip Lammers, M.D., on biosimilars, or check out our biosimilar slideshow.

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Brand name: Kanjinti

Chemical name: Trastuzumab-anns

Class: HER2 (human epidermal receptor 2) inhibitor targeted therapy. Herceptin, Herzuma, Nerlynx, Ogivri, Ontruzant, Perjeta, Trazimera, and Tykerb are other HER2 inhibitors.

Uses: Kanjinti typically is used to:

  • treat metastatic, HER2-positive breast cancer
  • reduce the risk of early-stage, HER2-positive disease coming back after surgery and other treatments as part of a regimen with chemotherapy medicines

How it’s given: Kanjinti is given intravenously

Additional information: Kanjinti is a biosimilar of Herceptin. Herceptin is a monoclonal antibody, “biologic” drug. This means that it is made from living organisms, in this case a protein from a mouse cell. A monoclonal antibody is a type of protein made in the lab that can bind to substances in the body, including cancer cells. Each monoclonal antibody is made so that it binds only to one substance. Herceptin binds to the HER2 receptor proteins in cancer cells.

Because they are made from living organisms, biologic drugs are much more complex to make than conventional drugs that are made from a mixture of chemicals. The chemical structure of conventional drugs can be easily identified and duplicated, which is why there are so many generic drugs on the market.

A biosimilar is a new type of biologic drug. A biosimilar is almost identical to a biologic drug that is already approved by the FDA (or similar organizations in other countries). It can help to think of a biosimilar as a generic version of a biologic drug, though that comparison isn’t completely accurate.

The makers of biosimilars don’t have access to the original cell lines used to make the biologic drug. They also don’t have access to the exact purification process or other manufacturing steps used by the makers of the biologic drug.

Biologic drugs can be very sensitive to changes in the manufacturing process. If one small step is done differently, the biosimilar may have very different effects than the original biologic drug.

So, the U.S. Food and Drug Administration (FDA) requires that any biosimilar drug go through the same rigorous clinical trials that original biologic drugs do before the agency will approve the biosimilar.

Kanjinti is approved as a biosimilar, not as a product that is interchangeable with Herceptin. This means that if you start treatment with Herceptin, you can’t switch to Kanjinti in the middle of treatment. Similarly, if you start treatment with Kanjinti, you can’t switch to Herceptin in the middle of treatment.

Side effects:

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Kim Wakiyama joined the Breastcancer.org team in 2010 as an event coordinator on the Development team. Kim is involved in all fundraising events including Breastcancer.org’s signature events: Rock the Ribbon, Baubles, and the Garden Party. Kim specializes in Breastcancer.org’s many live, silent, and online fundraising auctions. She also works with corporate partners to develop cause-marketing promotions.

“The best part of my job is meeting the people who are passionate about Breastcancer.org. They have used the site and are truly grateful for what we do.”

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Women diagnosed with a childhood cancer who developed breast cancer as an adult were more likely to die after being diagnosed with breast cancer compared to women who did not have childhood cancer, according to a study.

While childhood cancer survivors were a bit more likely to die from breast cancer, they were much more likely to die because of other health issues, suggesting that childhood cancer survivors need follow-up care that includes regular screenings for possible complications of the earlier care.

The research was published online on July 1, 2019, by the Journal of Clinical Oncology. Read the abstract of “Mortality After Breast Cancer Among Survivors of Childhood Cancer: A Report From the Childhood Cancer Survivor Study.

How the study was done

Earlier research has shown that women diagnosed with cancer as children have a higher risk of being diagnosed with breast cancer as adults. This higher risk is due to a number of factors, including treatments for childhood cancer, such as chest radiation therapy and chemotherapy.

For this study, researchers wanted information on survival after a breast cancer diagnosis in women who had been treated for childhood cancer.

The Childhood Cancer Survivor Study was started in 1994 to better understand the health problems that may develop years after childhood cancer treatment. Originally, childhood cancer survivors diagnosed between 1970 and 1986 and their siblings were included in the study. Because of advances in the treatment of childhood cancer, a second group of childhood cancer survivors diagnosed between 1987 and 1999 and their siblings also were included in the study.

This study included 277 people who had been treated for childhood cancer between 1970 and 1986 and were later diagnosed with breast cancer as an adult. Three of these people were men, and they were not included in the analysis.

Among the 274 women:

  • 71% had been treated with chest radiation for childhood cancer
  • 61% had been treated with chemotherapy for childhood cancer
  • 64% had been diagnosed with Hodgkin lymphoma as children
  • 336 breast cancers were diagnosed; 62 women had two breast cancers diagnosed
  • half were younger than 38 when diagnosed with breast cancer and half were older; age at breast cancer diagnosis ranged from 20 to 58

Of the 336 breast cancers diagnosed:

  • 74% were invasive
  • 24% were DCIS
  • 68% of the invasive cancers were stage I or stage II when diagnosed
Survival statistics

The researchers compared the outcomes after being diagnosed with breast cancer in the women with a history of childhood cancer to outcomes in a similar group of women who had been diagnosed with breast cancer but had not been diagnosed with childhood cancer.

Overall, 92 women who developed breast cancer as an adult after a childhood cancer diagnosis had died. The risk of dying from any cause after a breast cancer diagnosis was more than twice as high among women who were childhood cancer survivors compared to women who did not have childhood cancer.

Of the women with a history of childhood cancer who died, 49 died as a result of breast cancer. The risk of dying from breast cancer was a bit higher among women who had been diagnosed with childhood cancer than among women who did not have childhood cancer. Still, the researchers pointed out that the childhood cancer survivors were more than five times as likely to die of other health issues, including other cancers and heart/lung problems compared to women with no history of childhood cancer.

“Although [breast cancer] specific mortality was modestly higher in childhood cancer survivors, deaths attributable to health conditions other than [breast cancer] seem to be the driving force in the elevated all-cause mortality,” the researchers wrote.

Among the 43 women with a history of childhood cancer who died from causes other than breast cancer:

  • 18 were due to another cancer
  • 14 were due to heart issues
  • 7 were due to lung issues
What this means for you

If you were treated for cancer as a child, it’s particularly important that you regularly see a doctor who:

  • is familiar with your medical history
  • understands the unique risks you have
  • can give you the appropriate counseling, monitoring, and screening for possible complications of your earlier cancer treatment

Still, research has shown that many childhood cancer survivors don’t get recommended follow-up care, in part because not all doctors know how to provide this care.

"Although guidelines recommend related follow-up care, many primary care physicians are unaware of these guidelines, and many childhood cancer survivors are not receiving the recommended surveillance,” the researchers wrote. "Our results emphasize the need for this population with a high risk of mortality to be followed by clinicians familiar with the health conditions faced by childhood cancer survivors."

It’s also important to know that treatment for childhood cancer increases the risk of being diagnosed with breast cancer. If you were treated for childhood cancer, you and your doctor should strongly consider a more aggressive breast cancer screening plan. This plan might include more frequent mammograms starting at an earlier age than the recommended age of 40, and possibly using different imaging techniques, such as MRI or ultrasound.

Written by: Jamie DePolo, senior editor

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Women of Ashkenazi Jewish descent who know they have a mutation in the BRCA1 or BRCA2 gene, but decided not to have preventive mastectomy, have better outcomes if they’re diagnosed with breast cancer compared to Ashkenazi Jewish women who don’t know they have a mutation, according to a study.

The research was presented at the European Society of Human Genetics Annual Meeting on June 16, 2019. Read the abstract of “Impact of germline BRCA mutation identification on subsequent breast cancer stage, therapy and survival — implications for routine screening.”

Gene mutations linked to breast cancer

Two of the most well-known genes that can mutate and raise the risk of breast and/or ovarian cancer are BRCA1 and BRCA2. Women who inherit a mutation in either of these genes — from their mothers or their fathers — have a much higher-than-average risk of developing breast cancer and/or ovarian cancer.

Men with these mutations have an increased risk of breast cancer, especially if the BRCA2 gene is affected, and possibly of prostate cancer.

About 5% to 10% of breast cancers are thought to be hereditary, meaning the cancer is linked to mutations in genes passed from parent to child.

You are substantially more likely to have a genetic mutation linked to breast cancer if:

  • You have blood relatives (grandmothers, mother, sisters, aunts) on either your mother's or father's side of the family who had breast cancer diagnosed before age 50.
  • There is both breast and ovarian cancer on the same side of the family or in a single individual.
  • You have a relative(s) with triple-negative breast cancer.
  • There are other cancers in your family in addition to breast, such as prostate, melanoma, pancreatic, stomach, uterine, thyroid, colon, and/or sarcoma.
  • Women in your family have had cancer in both breasts.
  • You are of Ashkenazi Jewish (Eastern European) heritage.
  • You are African American and have been diagnosed with breast cancer at age 35 or younger.
  • A man in your family has had breast cancer.
  • There is a known breast cancer gene mutation in your family.
Why do Ashkenazi Jewish women have a higher risk of breast cancer?

Ashkenazi Jewish women have a much higher risk of having a founder mutation in the BRCA1 and BRCA2 genes — about a 1 in 40 risk. This is part of the reason why Ashkenazi Jewish women have a much higher-than-average risk of breast cancer.

A founder mutation is a specific gene mutation in a population that was founded by a small group of ancestors that were geographically or culturally isolated. Because the population was isolated, the rate of founder mutations in descendants is much higher than it would be if the population were larger and intermingling with more genetically diverse people.

Even though Ashkenazi Jewish women have a higher risk of breast cancer, genetic testing to screen for mutations linked to breast cancer in all Ashkenazi Jewish women is not the current standard of care.

"The problem is that genetic screening for BRCA [mutations] by a saliva or blood test is not recommended by any medical body or health care organization in healthy Ashkenazi Jewish women without a strong family history,” said Rachel Rabinovitch, M.D., professor of radiation oncology at the University of Colorado School of Medicine and one of the study’s authors. “The way women usually find out they have a BRCA [mutation] is only after they are diagnosed with breast cancer, at which time we've lost the opportunity to offer surgery that could prevent breast cancer or start high-risk breast cancer screening at an age young enough to detect cancers earlier.”

Rabinovitch and her colleagues did this study to see if Ashkenazi women who knew they had a BRCA mutation and were diagnosed with breast cancer had different outcomes than Ashkenazi women who didn’t know if they had a BRCA mutation until after they were diagnosed with breast cancer.

How the study was done

The researchers looked at the medical records of 105 Ashkenazi Jewish women diagnosed with breast cancer between 2005 and 2016 who had a BRCA mutation. None of the women had had preventive mastectomy.

Of the 105 women:

  • 42 knew they had a BRCA mutation before they were diagnosed
  • 63 women learned they had a BRCA mutation after they were diagnosed

Both groups of women had an average age of about 50 at diagnosis, and both groups had similar rates of BRCA1 (64%) and BRCA2 (36%) mutations.

Compared to women who didn’t know they had a BRCA mutation, women who knew they had a BRCA mutation were more likely to have:

  • a strong family history of breast cancer
  • previous breast cancer screening
  • been diagnosed by imaging, such as a mammogram, rather than clinical symptoms, such as feeling a lump

When looking at the breast cancers, women who knew they had a BRCA mutation were more likely to be diagnosed with cancers that were a lower stage at diagnosis than women who didn’t know they had a BRCA mutation.

There were no differences in tumor grade, hormone-receptor status, or HER2-receptor status between the two groups.

Compared to women who didn’t know they had a BRCA mutation, women who knew about a mutation were:

  • less likely to be treated with chemotherapy
  • more likely to have a double mastectomy

Overall, knowing BRCA mutation status was linked to a higher likelihood of being diagnosed with stage 0 or stage I breast cancer. The results also hinted that knowing BRCA mutation status might be linked to better survival, but the data were not mature enough to fully support this conclusion.

“We found that women who knew they were BRCA positive and chose to keep their breasts were much more likely to be diagnosed with noninvasive breast cancer, earlier stage invasive breast cancer, and need less morbid cancer therapy; but most importantly their survival was better," Rabinovitch said. She suggested that the results argue for routine BRCA screening in women of Ashkenazi Jewish descent.

"However even among those of us who did the study, we do not agree on when is the best age for genetic screening," she added. "My colleagues who live in Israel suggest it should be done at age 30 — the age at which significant cancer risk begins — but I think that's too late.

"Testing at age 30 is useful for the woman — it's before she is likely to develop breast or ovarian cancer and so offers her the opportunity for surgical prevention or increased cancer screening. However, by that age, many women have made the decision to get pregnant, and you've deprived them of the option to undergo procedures which would prevent passing on the BRCA mutation to their children. While not all women will choose this, I think they should be given the opportunity to do so."

What this means for you

If you are of Ashkenazi Jewish descent, it makes sense to talk to your doctor about your personal risk of breast cancer. When calculating your personal risk, you and your doctor will take into account your family history of breast cancer, your age, your ethnicity, any earlier breast biopsies you’ve had, and your breast density, among other factors.

Based on your risk, your doctor may recommend you have genetic testing. A licensed certified genetic counselor or your doctor can help you understand the test and accurately interpret the results.

If you do have a mutation linked to breast cancer, there are lifestyle choices you can make to keep your risk as low as it can be, including:

  • maintaining a healthy weight
  • exercising regularly
  • limiting alcohol
  • never smoking
  • eating a diet rich in unprocessed, nutrient-dense foods (foods that have the most vitamins, minerals, and healthy compounds)

There are also more aggressive steps you can take to reduce your risk of breast cancer, including:

  • more frequent screening that starts at a younger age
  • taking a medicine such as tamoxifen, Evista (chemical name: raloxifene), Aromasin (chemical name: exemestane), or Arimidex (anastrozole)
  • removing the healthy breasts and ovaries — called prophylactic or protective surgery — before cancer develops

For more information on genetic testing, including types of genetic tests and how results are reported, visit the Breastcancer.org Genetic Testing pages.

For more information on genes and genetic mutations linked to breast cancer, as well as all the risk-lowering steps you can take if you have a genetic mutation, visit the Breast Cancer Risk Factors: Genetics page in the Breastcancer.org Lower Your Risk section.

To discuss being at high risk for breast cancer with other people, join the Breastcancer.org Discussion Board forum, High Risk for Breast Cancer. If you've tested positive for a mutation linked to breast cancer and would like to talk about this with others who have also tested positive, join the forum, Positive Genetic Test Results.

Written by: Jamie DePolo, senior editor

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Herceptin (chemical name: trastuzumab) is a monoclonal antibody, a targeted therapy medicine used to treat HER2-positive breast cancers. Herceptin is what’s called a “biologic” drug. This means that it is made from living organisms, in this case a protein from a mouse cell. A monoclonal antibody is a type of protein made in the lab that can bind to substances in the body, including cancer cells. Each monoclonal antibody is made so that it binds only to one substance. Herceptin binds to the HER2 receptor proteins in cancer cells.

Because they are made from living organisms, biologic drugs are much more complex to make than conventional drugs that are made from a mixture of chemicals. The chemical structure of conventional drugs can be easily identified and duplicated, which is why there are so many generic drugs on the market.

A biosimilar is a new type of biologic drug. A biosimilar is almost identical to a biologic drug that is already approved by the U.S. Food and Drug Administration (FDA) (or similar organizations in other countries). It can help to think of a biosimilar as a generic version of a biologic drug, though that comparison isn’t completely accurate.

The makers of biosimilars don’t have access to the original cell lines used to make the biologic drug. They also don’t have access to the exact purification process or other manufacturing steps used by the makers of the biologic drug.

Biologic drugs can be very sensitive to changes in the manufacturing process. If one small step is done differently, the biosimilar may have very different effects than the original biologic drug.

So the FDA requires that any biosimilar drug go through the same rigorous clinical trials that original biologic drugs do before the agency will approve the biosimilar.

A study suggests that a drug that is a biosimilar to Herceptin, called MYL-1401O, is as effective and as safe as Herceptin.

The research was published online on Dec. 1, 2016 by the Journal of the American Medical Association. Read the abstract of “Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Randomized Clinical Trial.”

The results, which were also presented at the American Society of Clinical Oncology Annual Meeting on June 3, 2016, are the first to show that a biosimilar to an approved biologic drug has the same effects on cancer as the original drug, according to Hope Rugo, M.D., professor of medicine at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center and lead author of the study. Dr. Rugo also is a member of the Breastcancer.org Professional Advisory Board.

In the study, 458 women diagnosed with metastatic, HER2-positive breast cancer were randomly assigned to receive one of two treatments:

  • Herceptin with either Taxol (chemical name: paclitaxel) or Taxotere (chemical name: docetaxel) (228 women)
  • MYL-1401O with either Taxol or Taxotere (230 women)

The women received a minimum of eight cycles of treatment.

None of the women had been treated with chemotherapy or Herceptin for metastatic disease, and 44% of the women had breast cancer that also was hormone-receptor-positive.

Metastatic breast cancer is cancer that has spread away from the breast area to another part of the body, such as the liver or bones.

Neither the doctors nor the women knew which medicine the women were getting.

After 24 weeks, the researchers looked to see how the cancers were responding to the treatment.

Overall response rates were:

  • 69.6% for MYL-1401O
  • 64% for Herceptin

After 48 weeks, there was no difference in either progression-free survival or overall survival between the biosimilar and Herceptin:

  • progression-free survival rates were 44% for MYL-1401O and 45% for Herceptin
  • overall survival rates were 89% for MYL-1401O and 85% for Herceptin

Progression-free survival is how long a person lives without the cancer growing. Overall survival is how long a person lives whether or not the cancer grows.

The risk of side effects also was similar for the two medicines:

  • 57.5% of women getting MYL-1401O and 53.3% of women getting Herceptin had low white blood counts
  • 23.1% of women getting MYL-1401O and 24.8% of women getting Herceptin had peripheral neuropathy
  • 20.6% of women getting MYL-1401O and 20.7% of women getting Herceptin had diarrhea

The experimental biosimilar MYL-1401O has not been approved by the FDA yet, though Mylan, the company that makes MYL-1401O, filed a biologics license application with the FDA in November 2016.

Dr. Rugo said in an interview that if the new biosimilar is approved by the FDA, it could allow more access to treatment for women diagnosed with HER2-positive breast cancer.

“Lack of access is not a major issue in the United States,” she said, “because most patients have insurance that covers trastuzumab. I’ve not seen a situation where it wasn’t covered for a standard indication.”

Still, in other countries, cost can mean that some women don’t receive the treatment.

“It is expected that having biosimilars will reduce costs -- by some amount -- for these agents around the world,” Dr. Rugo said. Still, it is unclear how much less expensive biosimilars will be.

These results seem promising, but it’s not clear when or if MYL-1401O will be approved for use in the United States.

In an editorial that was published with the research, Howard Bauchner, M.D., editor in chief of the Journal of the American Medical Association, wrote that one of the sponsors of this study, Mylan, "has recently attracted attention because of the pricing, promotion, and involvement in the health policies of schools regarding one of its products, injectable epinephrine (EpiPen). There has been substantial criticism of the company by patients, physicians, and politicians about the recent price increase and the subsequent introduction of a generic epinephrine product by the same company.

"The proposed trastuzumab biosimilar will need to be priced at a level at which patients who otherwise would not have access to expensive therapies such as trastuzumab could receive needed therapy. In announcing their FDA submission for the proposed trastuzumab biosimilar, the sponsors of the trial by Rugo et al have expressed their 'shared commitment to increasing access to these critical medicines worldwide' and indicated that 'this advancement in the U.S. will enable us to enhance access to this affordable therapy to larger patient pools.' Ultimately, to fulfill these pledges the manufacturers must ensure that the pricing of this biosimilar product is responsible and fair and provides access to this important therapy at an affordable price."

While MYL-1401O is the first biosimilar cancer drug to be reported on, biosimilar drugs are being developed by a number of different companies. It’s likely that there will more studies in the future. So stay tuned to Breastcancer.org for the latest information on biosimilar drugs for breast cancer and what that might mean for you.

Editor's Note: On Dec. 1, 2017, the U.S. Food and Drug Administration approved Ogivri (chemical name: trastuzumab-dkst), a biosimilar for Herceptin, to treat people with HER2-positive breast cancer or HER2-positive metastatic stomach cancer. Ogivri was previously known as MYL-1401O.

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Combining breast density information with a woman’s 5-year breast cancer risk estimate can help doctors figure out which women are at high risk for the disease and should therefore have additional screening beyond yearly mammograms, according to a study.

The research was published online on July 1, 2019, by the journal JAMA Internal Medicine. Read the abstract of “Strategies to Identify Women at High Risk of Advanced Breast Cancer During Routine Screening for Discussion of Supplemental Imaging.”

What is breast density and how is it measured?

Dense breasts have less fatty tissue and more non-fatty tissue compared to breasts that aren't dense.

One way to measure breast density is the thickness of the breast tissue on a mammogram. The BI-RADS (Breast Imaging Reporting and Database System), which reports the findings of mammograms, also includes information on breast density. BI-RADS classifies breast density into one of four groups:

  • mostly fatty
  • scattered areas of density
  • consistently dense
  • extremely dense

Still, no one method of measuring breast density has been agreed upon by doctors. Breast density is not based on how your breasts feel during your self-exam or your doctor's physical exam. Dense breasts have more gland tissue that makes and drains milk and supportive tissue (also called stroma) that surrounds the gland.

Research has shown that dense breasts:

  • can be twice as likely to develop cancer as nondense breasts
  • can make it harder for mammograms to detect breast cancer; breast cancers (which look white like breast gland tissue) are easier to see on a mammogram when they're surrounded by fatty tissue (which looks dark)

Nearly half of women age 40 and older in the United States are classified as having dense breasts.

Proposed U.S. legislation would require doctors to discuss supplemental breast cancer screening with women who have dense breasts. Still, other research has shown that not all women with dense breasts have a higher risk of breast cancer. So these women with dense breasts at average risk of breast cancer would not need additional screening. The purpose of this study was to better identify women with dense breasts at high-risk of breast cancer who would benefit the most from additional screening.

How 5-year breast cancer risk was estimated

To estimate the 5-year risk of breast cancer for each woman in the study, the researchers used the Breast Cancer Surveillance Consortium Risk Calculator.

The Breast Cancer Surveillance Consortium is a collaborative network of breast imaging registries doing research to assess and improve the delivery and quality of breast cancer screening in the United States. The Breast Cancer Surveillance Consortium Risk Calculator is an interactive tool designed by researchers that participate in the Breast Cancer Surveillance Consortium to estimate a woman’s 5-year risk of developing invasive breast cancer. The calculator was designed to be used by healthcare professionals. If a woman uses the tool and she is not a healthcare professional, the consortium encourages her to discuss the results with her doctor.

How the study was done

To do the study, the researchers looked at the medical histories of 638,856 women ages 40 to 74 who had screening mammograms done at a Breast Cancer Surveillance Consortium imaging facility from Jan. 3, 2005, to Dec. 31, 2014.

The researchers used BI-RADS classifications to determine each woman’s breast density. As mentioned above, the Breast Cancer Surveillance Consortium Risk Calculator was used to determine each woman’s 5-year risk of developing invasive breast cancer.

Overall, 47% of the women in the study had consistently dense or extremely dense breasts.

The researchers then looked to see how many women were diagnosed with stage IIB or higher breast cancer within 1 year of a screening mammogram.

The researchers found that 60% of the stage IIB or higher breast cancers were diagnosed in women with dense breasts.

Overall, 12.5% of the women had dense breasts and a high risk of breast cancer. High rates of stage IIB or higher breast cancer were diagnosed in women with a:

  • 5-year breast cancer risk score of 2.5% or higher and consistently dense breasts (6% of the women)
  • 5-year breast cancer risk score of 1.0% or higher and extremely dense breasts (6.5% of the women)

"Studies consistently report that women can experience anxiety and concern in response to breast density notification, and most practitioners are not prepared to counsel women about breast density and are uncertain about offering supplemental imaging," the researchers wrote. "Our findings provide important information to guide women and practitioners about when supplemental imaging may be most beneficial and when it would not."

The researchers also said that 5-year breast cancer risk should be calculated every 3 to 5 years to ensure that women at high risk of the disease are identified.

What this means for you

If you learn that you have dense breasts and are unsure what that means, contact a member of your healthcare team to learn how your breast density affects your personal risk of breast cancer. While you’re talking about your breast density, you may want to bring up this study and ask your doctor to calculate your 5-year risk of invasive breast cancer. If you do have a higher-than-average risk of breast cancer, talk to your doctor about additional screening, including MRI and ultrasound.

There are also lifestyle choices you can make to keep your risk of breast cancer as low as it can be, including:

  • maintaining a healthy weight
  • exercising every day
  • limiting or avoiding alcohol
  • eating a healthy diet full of fresh, whole foods and avoiding processed foods with a lot of added sugar and salt
  • never smoking (or quitting if you do smoke)
  • breastfeeding, if you have the option to do so

For more information on steps you can take to keep your breast cancer risk as low as it can be if you have dense breasts, visit the Dense Breasts page in the Breastcancer.org Lower Your Risk section.

Written by: Jamie DePolo, senior editor

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Screening with MRI finds breast cancers at an earlier stage than mammograms in women with a family history of the disease, but this benefit may come with the risk of more overdiagnosis and false-positive results, especially in women with dense breasts, according to a Dutch study.

The research was published online on June 17, 2019, by The Lancet Oncology. Read the abstract of “MRI versus mammography for breast cancer screening in women with familial risk (FaMRIsc): a multicenter, randomised, controlled trial.”

Mammograms and MRI

A conventional mammogram creates a two-dimensional image of the breast from two X-ray images of each breast. Three-dimensional (3D) mammography (also called digital breast tomosynthesis, digital tomosynthesis, or just tomosynthesis), is a newer technology that creates a 3D picture of the breast, but that technology was not used in this study.

Magnetic resonance imaging — MRI — uses powerful magnets and radio waves to create detailed images of the organs and tissues in your body.

Overdiagnosis and false-positive results

Overdiagnosis means either:

  • a breast cancer screening test finds a suspicious area that would have been eventually diagnosed as cancer by other means, without any effect on prognosis
  • a breast cancer screening test finds a suspicious area that never would have affected a woman’s health if it hadn’t been found or treated

When a breast cancer screening test shows an abnormal area that looks like a cancer but turns out to be normal, it’s called a false positive. Ultimately the news is good: no breast cancer. But the suspicious area usually requires follow-up with more than one doctor, extra tests, and extra procedures, including a possible biopsy. There are psychological, physical, and economic costs that come with a false positive.

How the study was done

This study was done between Jan. 1, 2011, and Dec. 31, 2017, and included 1,355 Dutch women age 30 to 55 who had a lifetime risk of breast cancer of 20% or higher because of family history. None of the women had a BRCA1, BRCA2, or TP53 mutation, all of which are linked to a higher risk of breast cancer. Also, none of the women had been diagnosed with invasive breast cancer.

The women were randomly assigned to one of two screening programs:

  • annual MRI and clinical breast exam, plus a mammogram every other year (675 women)
  • annual mammogram and clinical breast exam (680 women)

Overall, MRI screening detected more breast cancers than mammography screening:

  • MRI found 40 cancers
  • mammography found 15 cancers

Invasive cancers detected were smaller in the MRI screening group:

  • MRI found 24 invasive cancers with a median size of 9 millimeters (mm)
  • mammography found 8 invasive cancers with a median size of 17 mm

The stages of the breast cancers found by MRI were earlier than the stages of the cancers found by mammography:

  • 12 breast cancers in the MRI group and one cancer in the mammography group were stage T1a or stage T1b
  • one cancer in the MRI group and two cancers in the mammography group were stage T2 or higher

In the TNM staging system, T describes the cancer tumor. T1, T2, T3, and T4 are based on the size of the tumor and the extent to which it has grown into nearby breast tissue. The higher the T number, the larger the tumor and/or the more it may have grown into breast tissue.

"We conclude that in real-life practice, MRI screening can result in an important and favourable shift in tumour stage at time of breast cancer detection compared with mammography screening, reducing the incidence of late-stage cancers and thus reducing the need for adjuvant chemotherapy and the risk of mortality," the researchers wrote.

Still, the researchers also said that the advantages of MRI screening might be at the cost of more false-positive results, especially in women with dense breasts. Other research has suggested that breast cancer screening with MRI leads to higher biopsy rates and these biopsies find fewer cancers than screening and biopsy with mammography.

What this means for you

If you have a higher-than-average risk of breast cancer because of family history, it’s a good idea to talk to your doctor about starting annual mammograms at a younger age and using other screening tools, such as MRI or ultrasound, to maximize the opportunity for early detection.

While breast cancer screening with MRI may lead to more false-positive results, a number of experts believe that overdiagnosis is better than underdiagnosis, especially in women who are age 50 and younger.

In an opinion piece that accompanied the research, Christiane Kuhl, M.D., of University Hospital Aachen in Germany, wrote, "In view of the devastating consequences of a late diagnosis of cancer, avoiding underdiagnosis should be deemed more important than avoiding overdiagnosis. We can alleviate much of the adverse consequences of overdiagnosis by providing patient information and appropriate selection of management."

In addition, earlier research found that while false-positive results do cause anxiety and stress for women, the anxiety is short-term and doesn’t affect a woman’s overall health and well-being.

For more information on the tests and tools used to screen for breast cancer, visit the Breastcancer.org Screening and Testing pages.

Written by: Jamie DePolo, senior editor

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