Trial record 1 of 1 for:    Breast BRE09-146
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PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations

This study is ongoing, but not recruiting participants.
Clovis Oncology, Inc.
Information provided by (Responsible Party):
Hoosier Cancer Research Network Identifier:
First received: February 23, 2010
Last updated: August 20, 2014
Last verified: August 2014

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.

Condition Intervention Phase
Breast Cancer
Drug: Cisplatin
Drug: Rucaparib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PARP Inhibition After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer or ER/PR +, HER2 Negative With Known BRCA1/2 Mutations: Hoosier Oncology Group BRE09-146

Resource links provided by NLM:

Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • Two-year Disease Free Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To evaluate 2-year disease-free survival (DFS), in patients with confirmed TNBC or ER/PR + HER2-, known BRCA1/2 mutations treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy

Secondary Outcome Measures:
  • Side Effects and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To characterize the side effects and tolerability of cisplatin and cisplatin plus Rucaparib in patients with residual disease following preoperative chemotherapy.

  • One-year Disease Free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate 1-year DFS

  • Overall Survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    To determine 5-year overall survival

  • Pharmacokinetic Data [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To collect limited pharmacokinetic data, in patients receiving study drug to compliment ongoing PK analyses in other trials with Rucaparib

  • Specimen Collection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To collect peripheral blood lymphocytes, archived tumor specimens, and genomic DNA to explore potential correlates of PARP inhibition, recurrence and toxicity.

Estimated Enrollment: 135
Study Start Date: February 2010
Estimated Study Completion Date: May 2015
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A: Cisplatin Monotherapy
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
Drug: Cisplatin
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
Active Comparator: Arm B: Combination Therapy

Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles

Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles

Drug: Rucaparib
Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
Drug: Cisplatin
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01074970

  Hide Study Locations
United States, California
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
University of California Los Angeles
Los Angeles, California, United States, 90095
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
Memorial Cancer Institute Breast Cancer Center
Hollywood, Florida, United States, 33021
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Indiana
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
Community Regional Cancer Center
Indianapolis, Indiana, United States, 46256
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Horizon Oncology Research, Inc./IU Health Arnett
Lafayette, Indiana, United States, 47905
Monroe Medical Associates
Munster, Indiana, United States, 46321
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
United States, Michigan
Metro Health Cancer Care
Wyoming, Michigan, United States, 49519
United States, Missouri
Siteman Cancer Center
St. Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
United States, New Jersey
The Center for Cancer & Hematologic Disease
Cherry Hill, New Jersey, United States, 08003
Virtua Health Cancer Program
Mount Holly, New Jersey, United States, 08060
South Jersey Health Care
Vineland, New Jersey, United States, 08360
United States, New Mexico
Presbyterian Medical Group
Albuquerque, New Mexico, United States, 87110
University of New Mexico Cancer Center: Albuquerque
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
HOPE a Women's Cancer Center
Asheville, North Carolina, United States, 28806
United States, Ohio
Seidman Cancer Center
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pinnacle Health Fox Chase Regional Cancer Center
Harrisburg, Pennsylvania, United States, 17110
Bux-Mont Oncology Hematology Associates (FCCC) at Grand View Hospital
Sellersville, Pennsylvania, United States, 18960
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38138
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Hoosier Cancer Research Network
Clovis Oncology, Inc.
Study Chair: Kathy D. Miller, M.D. Hoosier Cancer Research Network
  More Information

Additional Information:
Sujaata Dwadasi, Yan Tong, Tom Walsh, Michael A. Danso, Cynthia X. Ma, Paula Silverman, Mary-Claire King, Susan M. Perkins, Sunil S. Badve, Kathy Miller. Cisplatin with or without rucaparib after preoperative chemotherapy in patients with triple-negative breast cancer (TNBC): Hoosier Oncology Group BRE09-146. J Clin Oncol 32:5s, 2014 (suppl; abstr 1019^)

Responsible Party: Hoosier Cancer Research Network Identifier: NCT01074970     History of Changes
Other Study ID Numbers: BRE09-146
Study First Received: February 23, 2010
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoosier Cancer Research Network:
PARP inhibition + breast cancer
breast cancer
PARP inhibitor
Triple negative

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on April 23, 2015