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Research Studies of Interest for the HBOC Community

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The following studies may help us find better ways to prevent or treat cancers in people with a BRCA mutation or hereditary cancer. Learn more about specific studies by searching for a study’s unique identifier at clinicaltrials.gov or visiting a study’s website. Visit the FORCE website to learn more about HBOC research.

Prevention

Prophylactic Salpingectomy with Delayed Oophorectomy
Study Identifier Number: NCT01907789

This study compares ovarian cancer risk management options: screening, risk-reducing salpingo-oophorectomy (removal of both ovaries and fallopian tubes), and prophylactic salpingectomy (removal of fallopian tubes only) with delayed oophorectomy, which does not cause surgical menopause; the ovaries are removed at a later date. The study’s goal is to learn how many patients have their ovaries removed at a later date, and whether removal of fallopian tubes decreases the risk of ovarian cancer.

Comparing Metformin to Placebo in Decreasing Atypical Cells in High-risk Patients
Study Identifier Number: NCT01905046

This study will be open to premenopausal women at increased risk for breast cancer, based on a prior biopsy with atypical hyperplasia, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), a strong family history of breast and/or ovarian cancer, a high Gail Model score, or a known BRCA mutation. The study will assess if the diabetes drug metformin decreases atypia and breast density in high-risk women.

Breast Cancer Treatment

BROCADE Study
Study Identifier Number: NCT01506609

Men and women aged 18 years or older who have advanced (metastatic) breast cancer due to a BRCA1 or BRCA2 gene mutation are invited to see if they qualify for the Brocade Study. This study will attempt to determine the safety and effectiveness of the investigational PARP inhibitor medication veliparib in combination with chemotherapy.

INFORM Study
Study Identifier Number: NCT01670500

The INFORM study f o r newly diagnosed breast cancer patients who have a BRCA mutation is evaluating whether the chemotherapy drug cisplatin is better than current standard chemotherapy drugs (cyclophosphamide/doxorubicin) for treating these patients. 

Phase II Clinical Trial of PM01183 in BRCA1/2-Associated or Unselected Metastatic Breast Cancer
Study Identifier Number: NCT01525589

This study is looking at the safety of a new agent, PM01183, in metastatic breast cancer, while assessing whether the presence of a known germline mutat ion in BRCA1/2 predicts response.

Ovarian Cancer Treatment

ARIEL2 Study
Study Identifier Number: NCT01891344

ARIEL 2 is a Phase II PARP inhibitor study enrolling women with platinumsensitive, relapsed, high-grade ovarian, fallopian tube or primary peritoneal cancer. The primary study will evaluate molecular markers to predict how a woman with ovarian cancer may respond to rucaparib treatment. Visit arielstudy.com for more information.

NOVA Study
Study Identifier Number: NCT01847274

NOVA is a phase III study of the PARP inhibitor niraparib as maintenance in platinum-sensitive ovarian cancer patients who have either a BRCA mutation or a tumor with highgrade serous histology, and who have responded to their most recent platinum chemotherapy.

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