Clinical Trials and Treatments Available for BRCA Positive Breast or Ovarian Cancer Patients

Knowing if you're BRCA positive may help you get more effective treatment if you have advanced stage breast or ovarian cancer, so it makes sense for more people to get tested now than it did in the past, said Helen Schiff, a breast cancer advocate and SHARE participant.

"In the adjuvant setting, there used to be very little that breast or ovarian cancer patients could do if they found out they were BRCA positive, other than have a prophylactic oopherectomy (removal of the ovaries) or a prophylactic mastectomy, and in the metastatic setting there was nothing you could do," said Schiff. "But now cisplatinum is being used to treat BRCA positive breast cancer in both the adjuvant and metastatic settings."

Though most PARP inhibitors are still in clinical trials and their safety and efficacy data is preliminary and therefore limited, they are a good possible choice for women with metastatic breast cancer or late-stage ovarian cancer. This is because there is no other targeted drug for BRCA positive breast or ovarian cancer. One PARP inhibitor, Olaparib, has already been FDA-approved for late stage ovarian cancer and is also in a trial for early stage breast cancer. See below to learn more about these trials, or search for more trials through SHARE's Clinical Trial Matching Service and/or BreastCancerTrials.org.

Many Clinical trials will pay for BRCA testing, and insurance companies will usually cover the cost as well if you fit the guidelines set by the National Comprehensive Cancer Network (NCCN), which is now recommending testing for a broader array of people than it did in the past.

NCCN has recently expanded its recommendations for testing for women with breast or ovarian cancer. For example, people should be tested if they have relatives with prostate or pancreatic cancer, and so should anyone under 60 with Triple Negative Breast Cancer or anyone under 40 with any type of breast cancer. These are just a few of the NCCN guideline changes. Be sure to check the complete guidelines here:

http://www.nccn.org/professionals/physician_gls/PDF/genetics_screening.pdf

(You'll need to create an account and log in to get this information. Once you've done that, go to page 3, and then click on "Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC-1)"

Hereditary Cancer Treatment Clinical Trials

Ovarian Cancer Treatment StudiesQUADRA is a study for women with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received at least 3 previous chemotherapy regimens (which may have include a PARP inhibitor).

ARIEL2 is a Phase 2 PARP inhibitor trial for women with relapsed, high-grade serous or endometrial ovarian cancer. ARIEL2 is now enrolling its expansion phase to include patients who have failed three lines of prior chemotherapy and are platinum sensitive or platinum resistant. All patients enrolled in the study will receive the PARP inhibitor rucaparib.

Breast Cancer Treatment Studies
OlympiA is the first clinical trial for people with a BRCA 1 or BRCA 2 mutation who have been recently diagnosed with stage 2 or stage 3 breast cancer. The study will evaluate whether the PARP inhibitor olaparib is safe and improves outcomes.

The EMBRACA trial is a Phase III study from BioMarin, with talazoparib, a PARP inhibitor, for patients with locally advanced and/or metastatic breast cancer with a BRCA mutation.

ABRAZO is a Phase II, 2-stage, 2-cohort study of talazoparib in locally advanced and/or metastatic breast cancer patients with BRCA mutation.

OlympiAD is a Phase III study comparing how olaparib (a PARP inhibitor) works compared to standard chemotherapy in patients with HER2 negative metastatic breast cancer who have a BRCA 1 or BRCA 2 mutation. Patients will be randomized 2 to 1, so patients will be twice as likely to receive olaparib than standard chemotherapy. Patients who may be eligible for the study, but do not know their BRCA mutation status, will be tested at no expense.

BRAVO is a trial for men and women who have HER2 negative, BRCA mutation positive breast cancer that progressed after prior treatment. BRAVO will compare niraparib (a PARP inhibitor) with standard chemotherapy.


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