PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

The purpose of this trial is to evaluate 2-year disease-free survival in this patient population treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy. Side effects and tolerability of this treatment in patients with residual disease following preoperative chemotherapy will also be observed and characterized.

Key facts

Study ID

NCT01074970

Run by

Hoosier Cancer Research Network

People needed

135

Starts

2010-02-01

Expected to finish

2018-12-15

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, stage I-III at diagnosis (AJCC 6th edition) based on initial evaluation by clinical examination and/or breast imaging. NOTE: Patients with ER+ and/or PR+ may enroll ONLY if they are known carriers of a deleterious mutation in BRCA1 or BRCA2. Patients with HER2+ tumors may not enroll regardless of BRCA status.
• Must have completed preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include an anthracycline or a taxane, or both. Patients may NOT have received cisplatin as part of their neoadjuvant therapy regimen. Patients who received preoperative therapy as part of a clinical trial may enroll. No adjuvant chemotherapy after surgery other than that specified in this protocol is allowed. Adjuvant bisphosphonate use is allowed.
• Must have completed definitive resection of primary tumor. The last surgery for breast cancer must have been completed at least 14 days prior to registration for protocol therapy.
• Must have significant residual invasive disease at the time of definitive surgery following preoperative chemotherapy. Significant residual disease is defined at least one of the following:
• Miller-Payne response in the breast of 0-25.
• Residual Cancer Burden (RBC) classification II or III6
• Residual carcinoma in one or more regional lymph nodes that would meet AJCC 6th edition criteria for N1 - N3 disease.
• Alternatively, if Miller-Payne or RCB grading is not available, the patient will be eligible if the pathology report indicates that the area of residual invasive disease in the breast measures at least 2 cm following preoperative therapy. The presence of DCIS without invasion does not qualify as residual disease in the breast.
• Whole breast radiotherapy is required for patients who underwent breast conserving therapy, including lumpectomy or partial mastectomy. Patients receiving adjuvant radiation therapy must have completed radiotherapy at least 14 days prior to registration for protocol therapy.
• Written informed consent and HIPAA authorization for release of personal health information.
• Age > 18 years at the time of consent.
• Must consent to allow submission of archived tumor tissue sample from definitive surgery.
• Must consent to collection of blood samples for PK analysis.
• Women of childbearing potential and males must be willing to use an effective method of contraception from the time consent is signed until 4 weeks after treatment discontinuation.
• Women of childbearing potential must have a negative pregnancy test within 14 days prior to registration for protocol therapy.
• Women must not be breastfeeding.

You may not qualify if…

• No stage IV (metastatic) disease, however no specific staging studies are required in the absence of symptoms or physical exam findings that would suggest distant disease.
• No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
• No history of chronic hepatitis B or C
• No clinically significant infections as judged by the treating investigator.

Where it is running

• St. Jude Heritage Healthcare — Fullerton, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Memorial Cancer Institute Breast Cancer Center — Hollywood, Florida, United States
• University of Miami, Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Fort Wayne Oncology & Hematology, Inc — Fort Wayne, Indiana, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Community Regional Cancer Center — Indianapolis, Indiana, United States
• Horizon Oncology Research, Inc./IU Health Arnett — Lafayette, Indiana, United States
• Monroe Medical Associates — Munster, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Metro Health Cancer Care — Wyoming, Michigan, United States
• Siteman Cancer Center — St Louis, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• The Center for Cancer & Hematologic Disease — Cherry Hill, New Jersey, United States
• Virtua Health Cancer Program — Mount Holly, New Jersey, United States
• South Jersey Health Care — Vineland, New Jersey, United States
• Presbyterian Medical Group — Albuquerque, New Mexico, United States
• University of New Mexico Cancer Center: Albuquerque — Albuquerque, New Mexico, United States
• HOPE a Women's Cancer Center — Asheville, North Carolina, United States
• Seidman Cancer Center — Cleveland, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Pinnacle Health Fox Chase Regional Cancer Center — Harrisburg, Pennsylvania, United States
• Bux-Mont Oncology Hematology Associates (FCCC) at Grand View Hospital — Sellersville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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