This section discusses emerging areas of research in the treatment of early breast cancer, including some tools for tailoring treatment.
Learn about promising, new treatments for metastatic breast cancer.
This is an exciting time in breast cancer research. New drugs are becoming available and treatment for early breast cancer is improving.
New chemotherapy, hormone therapy and targeted therapy drugs are under study in clinical trials. The results of these studies will decide whether these new therapies become part of standard care.
After discussing the benefits and risks with your health care provider, we encourage you to consider joining a clinical trial.
If you or a loved one needs information or resources about clinical trials, call our Clinical Trial Information Helpline at 1-877 GO KOMEN (1-877- 465- 6636) or email at email@example.com.
Learn more about clinical trials.
Capecitabine is a chemotherapy drug used to treat metastatic breast cancer. It’s now under study for early breast cancer treatment.
A randomized clinical trial studied women with HER2-negative early breast cancer who had cancer remaining in their breast after neoadjuvant (before surgery) chemotherapy. Standard treatment after surgery included radiation therapy and/or hormone therapy .
Women with triple negative breast cancer who got capecitabine after neoadjuvant chemotherapy had a lower risk of breast cancer recurrence and better overall survival at 5 years compared to women who got standard treatment alone .
Tyrosine-kinase inhibitors are a class of drugs that target enzymes important for cell functions (called tyrosine-kinase enzymes). These drugs can block tyrosine-kinase enzymes at many points along the cancer growth pathway.
Tyrosine-kinase inhibitors include neratinib (Nerlynx), which is FDA-approved for the treatment of HER2-positive early breast cancer, and lapatinib (Tykerb), which is FDA-approved for the treatment of HER2-positive metastatic breast cancer.
Other tyrosine-kinase inhibitors are under study.
PI3 kinase is an enzyme important in cell growth. The PIK3CA gene helps control PI3 kinase enzyme activity.
Some breast cancers have a mutation in the PIK3CA gene (this mutation is in the genes of breast cancer, not the person). This mutation can affect PI3 kinase and cause the tumor to grow.
Researchers are studying whether PIK3CA mutations may help predict benefit from breast cancer treatments, including trastuzumab (Herceptin) [59-60].
Poly(ADP-ribose) polymerase (PARP) inhibitors are a class of drugs under study for many types of cancer, including breast cancer.
PARP is an enzyme involved in DNA repair. Some chemotherapy drugs damage DNA.
Adding a PARP inhibitor to some chemotherapy plans may lower the chances the cancer cells will become resistant to the chemotherapy. This is most often a problem for those with metastatic breast cancer.
PARP inhibitors appear to hold the most promise for people who have a BRCA1 or BRCA2 gene mutation .
The PARP inhibitor olaparib (Lynparza) is FDA-approved for the treatment of HER2-negative metastatic breast cancer in people who have a BRCA1 or BRCA2 gene mutation.
Studies are now looking at whether adding PARP inhibitors to treatment for early breast cancer in women with BRCA1/2 gene mutations can help lower the risk of breast cancer recurrence .
The PARP inhibitor velaparib in combination with neoadjuvant chemotherapy is under study for the treatment of triple negative breast cancer .
Some targeted therapies are special antibody drugs designed to target certain cancer cells. For example the drug trastuzumab (Herceptin) is a specially made antibody that targets HER2-positive cancer cells.
Antibody-drug conjugates are a combination of an antibody targeted therapy drug and a chemotherapy drug. The combination allows the targeted delivery of chemotherapy to certain cancer cells.
For example, antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla, T-DM1, trastuzumab emtansine) consists of trastuzumab linked to a chemotherapy called DM1.
Ado-trastuzumab emtansine targets the delivery of chemotherapy to HER2-positive cancer cells. It’s FDA-approved for the treatment of HER2- positive breast cancers.
Other antibody-drug conjugates are under study.
Some drugs are made from biological products (biologics) such as antibodies or proteins. Trastuzumab and pertuzumab (Perjeta) are breast cancer treatment drugs made from biologics (they are made from antibodies).
A biosimilar drug is a “generic like” version of a drug that contains biologics. It’s highly similar to the original drug.
The name of a biosimilar drug includes the name of the original biologic drug. For example, trastuzumab-dkst is a biosimilar form of the drug trastuzumab.
A biosimilar drug may cost less than the original drug.
To be approved by the U.S. Food and Drug Administration (FDA), the biosimilar drug must work the same way as the original drug and it must have the same :
The side effects of the biosimilar drug cannot be different from those of the original drug. Also, the biosimilar drug must be the same form as the original drug. For example, if the original drug is given by vein (through and IV) the biosimilar drug must also be given by vein.
At this time, the FDA-approved biosimilar drugs for breast cancer treatment are all biosimilar forms of trastuzumab. They can be used to treat early and metastatic HER2-positive breast cancers:
Other biosimilar drugs for breast cancer are under study.
There are biosimilar forms of some drugs used to treat side effects of chemotherapy and other breast cancer treatments.
For example, some people get a white blood cell growth factor drug, such as filgrastim (Neupogen) or pegfilgrastim (Neulasta), to help maintain their blood counts during chemotherapy. Tbo-filgrastim (Granix) and pegfilgrastim-jmdb (Fulphila) are the biosimilar forms of these drugs.
Drugs that help the body’s immune system attack cancer cells are now used to treat many cancers (including melanoma, lung cancer, bladder cancer and kidney cancer). Overall, immunotherapy drugs are not as promising for breast cancer compared to other cancers at this time. However, they may be effective in treating some breast cancers.
There are many types of immunotherapy drugs under study.
Some immunotherapy drugs “take the brakes off” the natural factors that limit how the immune system can control tumor cells. For this reason, they are sometimes called “checkpoint inhibitors.” The checkpoint inhibitor atezolizumab (Tecentriq) is FDA-approved for the treatment of some metastatic breast cancers.
Other immunotherapies include vaccines. Like vaccines that protect against the flu or measles, cancer vaccines are designed to build up the body's immunity against disease.
Cancer vaccines may be made up of cancer cells or parts of cancer cells. These cells stimulate the body's natural defenses, helping it attack and kill cancer cells.
Still in early stages of development, cancer vaccines could one day be used to prevent breast cancer recurrence in people with early breast cancer . Clinical trials are underway.
Every cell in your body has genes that contain the blueprints (genetic code) for your body. Similarly, every cell in a breast tumor has genes. These genes contain the blueprints for the tumor.
Tumor profiling (using gene expression profiling tools) gives information about the genes in cancer cells. These tests allow researchers to study hundreds of tumor genes at a time.
Tumor profiling tests take a sample of the tumor (removed during a biopsy or surgery) and look at a set of genes.
Specific genes (or combinations of genes) may give information about prognosis and may help guide treatment.
The gene profiles of some tumors may help predict whether the cancer is more likely to recur (come back) and metastasize (spread to other organs) .
People with breast tumors that have gene profiles showing a high risk of metastasis may be more likely to benefit from chemotherapy than those with tumors that have gene profiles showing a low risk.
At this time, the 3 tumor profiling tests recommended by the American Society of Clinical Oncology (ASCO) are Oncotype DX®, PAM50 (Prosigna®, and MammaPrint® [65-66].
These tumor profiling tests can help predict the risk of metastasis in some people with estrogen receptor-positive cancer and may be used to guide breast cancer treatment.
Other tumor profiling tests are under study.
Breast Cancer Index® is a tumor profiling test that looks at a set of 11 genes to give prognostic information for some breast cancers.
Breast Cancer Index may be considered in making treatment decisions for some estrogen receptor-positive, HER2-negative, lymph node-negative breast cancers .
Molecular and genetic differences in breast cancers may be useful in guiding the development of new targeted therapies.
Most studies divide breast cancer into 4 major molecular subtypes:
Although mainly used in research settings, these subtypes may be useful in tailoring treatment in the future.
Learn more about molecular subtypes of breast cancer.
Circulating tumor cell levels may help predict recurrence and survival in people with early breast cancer [67-69].
Some studies have found women with more circulating tumor cells had a worse prognosis than women who had few or no circulating tumor cells [67-69].
At this time, circulating tumor cell tests (sometimes called liquid biopsies) should not be used to guide breast cancer treatment. This topic is under study.
Circulating tumor cell levels are also under study for use in treatment for metastatic breast cancer .
Some types of anti-depressants called selective serotonin reuptake inhibitors (SSRIs) can interfere with the metabolism of tamoxifen (how tamoxifen works in the body) .
Whether these SSRIs may impact the effectiveness of tamoxifen is under study.
Some SSRIs, including fluoxetine (Prozac), buproprion (Wellbutrin), paroxetine (Paxil) and sertraline (Zoloft), may interfere with tamoxifen. However, it’s not known whether they might affect tamoxifen treatment for breast cancer.
If tamoxifen is part of your treatment plan, talk with your health care provider about potential drug interactions.
Learn about SSRI anti-depressants for the treatment of menopausal symptoms.
CYP2D6 is an enzyme that affects how the body metabolizes (breaks down and uses) certain medications.
In the past, researchers were interested in whether certain forms of the gene related to CYP2D6 function affected the hormone therapy drug tamoxifen.
Large studies found no difference in the risk of breast cancer recurrence in women with genes related to low CYP2D6 function compared to risk in women with genes related to normal or high CYP2D6 function [72-73].
There is no role for routine testing of CYP2D6 in women taking tamoxifen.
After talking with your health care provider, we encourage you to consider joining a clinical trial.
BreastCancerTrials.org in collaboration with Susan G. Komen® offers a custom matching service to help you find clinical trials that fit your needs.
Susan G. Komen® Breast Cancer Clinical Trial Information Helpline
If you or a loved one needs information or resources about clinical trials, call our Clinical Trial Information Helpline at 1-877 GO KOMEN (1-877- 465- 6636) or email firstname.lastname@example.org.
The Helpline offers breast cancer clinical trial education and support, such as:
Learn more about clinical trials and find a list of resources to help you find a clinical trial.
Our commitment to research
At Susan G. Komen®, we are committed to saving lives by meeting the most critical needs in our communities and investing in breakthrough research to prevent and cure breast cancer. Our Research Program is an essential driving force for achieving this mission.
Since our inception in 1982, Komen has provided funding to support research grants that have greatly expanded our knowledge of breast cancer and helped us understand that breast cancer is not just a single disease but many diseases, unique to each individual.
Going forward, our commitment to research will contribute significantly to our ability to achieve our Bold Goal of reducing the current number of breast cancer deaths in the U.S. by 50 percent by 2026.
To date, Komen has provided more than $988M to researchers in 47 states, the District of Columbia and 22 countries to support research that has resulted in a better understanding of breast cancer; earlier detection; personalized, less invasive treatments for what was once a “one-treatment-fits-all” disease; and improvements in both quality of life and survival rates.
Learn more about our continuing investment in research and the exciting research that we are funding, because nothing would make us happier than ending breast cancer forever.
*Please note, the information provided within Komen Perspectives articles is only current as of the date of posting. Therefore, some information may be out of date at this time.
Facts for Life: Biosimilars
Questions to Ask Your Doctor About Biosimilars
Research Fast Facts
Precision Medicine: Targeted Therapies
Breast Cancer Clinical Trial Information Helpline
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