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NCT01506609

The Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide or In Combination With Carboplatin and Paclitaxel Versus Placebo in Subjects With BRCA1 and BRCA2 Mutation and Metastatic Breast Cancer

Note: This study is also known as the BROCADE Study

Study identifier: NCT01506609
Full study details on clinicaltrials.gov

Name of PARP Inhibitor used in study:

Veliparib (Abbvie)

Eligibility:

  • Patients with BRCA1 or BRCA2 mutation
  • Must have confirmed metastatic breast cancer
  • Her2neu negative
    • or Her2neu positive and have received previous anti-Her2neu therapy or are ineligible for anti-Her2neu therapy
  • Subjects must have measurable disease

Exlusion Criteria

  • Patients must be at least 21 days out from prior chemotherapy, radiation therapy, or investigational agent
  • May not have received more than 1 prior line of cytotoxic chemotherapy
  • May not have received prior therapy with with temozolomide, a platinum agent, or a PARP inhibitor
  • May not have received prior taxane therapy for metastatic disease
  • May not have a history of brain or leptomeningeal metastasis
  • See clinicaltrials.gov website or contact study team for other exclusion criteria

Type of study:

Phase II study

Treatment:

Patients are randomized to one of 3 arms:

  • Veliparib on Day 1 thru 7 and temozolomide on Day 1 thru 5 of a 28-day cycle
  • Veliparib on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle
  • Placebo on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.

Study sites:

Contact study coordinators below where listed or for more information about all open sites:

Terri L Leahy, BA (847) 935-3179 terri.leahy@abbvie.com
Contact: Nancy Falotico (847) 937-0370 nancy.falotico@abbvie.com

Alabama

  • Birmingham - Recruiting
    UAB Comprehensive Cancer Center
    Principal Investigator: Dr. Andres Forero
    Contact: Felicia Witherspoon, RN, BSN: 205-934-4317
    or
    Valerie Caterinicchia, RN., Primary Nurse Phone: 205-934-5367 ext: 45367
    Email: Valerie.Caterinicchia@ccc.uab.edu
    Alma Del Grosso, RN., Clinical Trials Manager Email: almadelg@uab.edu

Arkansas
Little Rock - Recruiting
University of Arkansas Medical Sciences
Principal Investigator: Dr. Laura Hutchins
Contact: Chester Wicker: 501-686-8274

California

  • La Jolla - Recruiting
    Moores UCSD Cancer Center
    Principal Investigator: Dr. Teresa Helsten
    Study coordinator: Alice Coutinho
    Phone: 858-822-6039
    Email:     acoutinho@ucsd.edu
  • Los Angeles - Recruiting
    Cedars Sinai Medical Center
    Samuel Oschin Comprehensive Cancer Institute
    Principal Investigator: William Audeh, MD
    Research Nurse: Suzanne Swain Cabriales, RN
    Desk: 310-248-6733
    Mobile: 310-746-6006
    Email:     suzanne.swaincabriales@cshs.org
  • Los Angeles - Recruiting
    The Angeles Clinic and Research Institute
    Principal Investigator: Cathie Chung, PhD, MD
    Santa Monica
    Contact: Dr. Chung: 310-582-7900
    Email:     CChung@TheAngelesClinic.org
  • San Francisco - Recruiting
    Stanford Cancer Center
    Principal Investigator: Melinda Telli, MD
    Contact: Pei-Jen Chang: 650-725-0866

Colorado
Aurora - Recruiting
University of Colorado Hospital, Anschutz Medical Campus
Cancer Center
Principal Investigator: Dr. Virginia Borges
Contact: Contact: Tessa McSpadden: 720-848-0609

Florida

  • Boca Raton - Recruiting
    Lynn Cancer Institute
    Principal Investigator: Dr. Jane Skelton
    Contact: Sylvie Godbout: 561-955-4800
  • Fort Lauderdale - Recruiting
    Holy Cross Hospital - Michael & Dianne Bienes Comprehensive Cancer Center
    Principal Investigator: Dr. Leonard Seigel
    Contact: Jorge Adames, RN: 954-267-7750
  • Tampa - Recruiting
    Moffitt Cancer Center
    Principal Investigator: Heather Han, MD
    Contact: Clinical research coordinators: Mira Lacevic and Dawn Carney
    Phone: 813-745-8304, 813-745-1807
  • West Palm Beach - Recruiting
    Palm Beach Cancer Institute
    Principal Investigator: Dr. Marilyn Raymond
    Contact: Karen Minder: 561-366-4119

Illinois

  • Chicago - Recruiting
    Rush University Medical Center
    Principal Investigator: Lydia Usha, MD Ph: 312-563-2312
  • Chicago - Recruiting
    University of Chicago Medical Center
    Principal Investigator: Dr. Rita Nanda
    Contact: Jean Gibson, RN: 773-834-2167
  • Zion - Recruiting
    Midwestern Regional Medical Center
    Principal Investigator: Dr. Dennis Citrin
    Contact: Rebecca McQuillen: 847-731-4143

Maryland

  • Annapolis - Recruiting
    Anne Arundel Medical Center
    Principal Investigator: Dr. Jeanine Werner
    Contact: Venita Alston Crawford, BSN RN: 443-481-4393
  • Baltimore - Recruiting
    Mercy Medical Center
    Principal Investigator: David A. Riseberg, MD: 410-783-5858
    Research Nurse: Lisa McConnell, RN, Ph: 410-332-1200
  • Baltimore - Recruiting
    Greater Baltimore Medical Center (GBMC)
    Sandra and Malcolm Berman Cancer Institute
    Principal Investigator: Dr. Madhu Chaudhry
    Contact: Garnitha Ferguson, RN: 443-849-8089
  • Baltimore - Recruiting
    Johns Hopkins Kimmel Cancer Center
    Principal Investigator: Dr. Vered Stearns
    Contact: Clinical Trials Specialist: 410-955-8804

Massachusetts

  • Boston - Recruiting
    Massachusetts General Hospital
    Principal Investigator: Steven Isakoff, MD, PhD
    Research Nurse: Karleen Habin, RN, Ph: 617-726-1922
  • Boston - Recruiting
    Dana-Farber Cancer Institute
    Clinical Research Coordinator: Ryan Hodgeman Ph: 617-582-8688
    rhodgeman@partners.org
  • Boston - Recruiting
    Beth Israel Deaconess Medical Center:
    Nadine Tung, MD
    Phone: 617-667-1962 (or have her paged at 32018)

Michigan
Lansing - Recruiting
Sparrow Cancer Center
Principal Investigator: Dr. Gordan Srkalovic
Contact: Vicki Gilreath, RN: 517-364-2890

Missouri
St. Louis - Recruiting
Contact:
Terri L Leahy, BA (847) 935-3179 terri.leahy@abbvie.com
Nancy Falotico (847) 937-0370 nancy.falotico@abbvie.com
Refer to site reference ID/Investigator# 62724

New Jersey
New Brunswick - Recruiting
The Cancer Institute of New Jersey
Principal Investigator: Dr. Deborah Toppmeyer
Contact: Sherri Damaré, RN at: 732-235-9692 or 732-235-7408

New York

North Carolina
Durham - Recruiting
Duke University Medical Center
Principal Investigator: Dr. Paul Marcom
Contact: Nyssa Schwager, RN: 919-660-1278

Pennsylvania

  • Hershey- Recruiting
    Contact:
    Terri L Leahy, BA (847) 935-3179 terri.leahy@abbvie.com
    Nancy Falotico (847) 937-0370 nancy.falotico@abbvie.com
    Refer to site reference ID/Investigator#62723
  • Philadelphia - Recruiting
    University of Pennsylvania, Basser Research Center for BRCA
    Principal Investigator: Susan Domchek, MD
    Contact: Rebecca Cimildoro, RN at 215-662-7383
  • Pittsburgh - Recruiting
    UPMC Cancer Center
    Magee Women's Hospital
    Contact: Shannon Puhalla, MD or call study coordinator, Brenda Lee Steele: 412-641-2261

South Carolina
Charleston - Recruiting
MUSC Hollings Cancer Center
Principal Investigator: Dr. Rita Kramer
Contact: Marietta Gustilo: 843-792-4271

Tennessee
Memphis - Recruiting
The West Clinic
Principal Investigator: Lee Schwartzberg, MD
Contact: Tracy Stewart at: 901-683-0055 x 1236

Texas

  • Dallas - Recruiting
    Contact:
    Terri L Leahy, BA (847) 935-3179 terri.leahy@abbvie.com
    Nancy Falotico (847) 937-0370 nancy.falotico@abbvie.com
    Refer to site reference ID/Investigator#60745
  • Houston - Recruiting
    The Methodist Hospital
    Principal Investigator: Dr. Jenny Chang
    Contact: Maria Nina Salazar: 713-441-0629

Utah

Salt Lake City - Recruiting
Huntsman Cancer Institute
Principal Investigator: Dr. Saundra Buys
Contact: Emily Ostrander: 801-587-4567


International sites

Australia

Canada

Czech Republic

Denmark

Finland

Hungary
Szolnok - Recruiting
Contact:
Terri L Leahy, BA (847) 935-3179 terri.leahy@abbvie.com
Nancy Falotico (847) 937-0370 nancy.falotico@abbvie.com
Refer to site reference ID/Investigator#63928

Israel

Norway

Poland

Russian Federation

Slovakia

Ukraine

Page updated 01/30/13


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