Research & Clinical Trials

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NCT01506609 - BROCADE STUDY

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 BROCADE logo

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

California

  • La Jolla
    Moores UCSD Cancer Center
    Principal Investigator: Dr. Teresa Helsten
    Study coordinator: Alice Coutinho
    Phone: 858-822-6039
    Email: acoutinho@ucsd.edu
  • Los Angeles
    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
    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
    Stanford Cancer Center
    Principal Investigator: Melinda Telli, MD
    Contact: Pei-Jen Chang: 650-725-0866

Colorado

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

Florida

  • Boca Raton
    Lynn Cancer Institute
    Principal Investigator: Dr. Jane Skelton
    Contact: Sylvie Godbout: 561-955-4800
  • Fort Lauderdale
    Holy Cross Hospital - Michael & Dianne Bienes Comprehensive Cancer Center
    Principal Investigator: Dr. Leonard Seigel
    Contact: Jorge Adames, RN: 954-267-7750
  • Tampa
    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
    Palm Beach Cancer Institute
    Principal Investigator: Dr. Marilyn Raymond
    Contact: Karen Minder: 561-366-4119

Illinois

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

Maryland

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

Massachusetts

  • Boston
    Massachusetts General Hospital
    Principal Investigator: Steven Isakoff, MD, PhD
    Research Nurse: Karleen Habin, RN, Ph: 617-726-1922
  • Boston
    Dana-Farber Cancer Institute
    Clinical Research Coordinator: Ryan Hodgeman Ph: 617-582-8688
    rhodgeman@partners.org

  • Boston
    Beth Israel Deaconess Medical Center:
    Nadine Tung, MD
    Phone: 617-667-1962 (or have her paged at 32018)

Michigan

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

Missouri

  • St. Louis
    Principal Investigator: Dr. Foluso Ademuyiwa
    Contact Name: Shana Thomas
    Contact Number 314-594-7754

New Jersey

  • New Brunswick
    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

  • New York City
    Beth Israel Medical Center
    Principal Investigator: Dr. Stephen Malamud
    Contact Name: Sherly Jacob-Perez
    Contact Number: 646-601-5899

North Carolina

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

Pennsylvania

  • Hershey
    Penn State Hershey Medical Center
    Principal Investigator: Dr. Allan Lipton
    Contact Name: Cynthia Campbell Baird
    Contact Number: 717-312-3401
  • Philadelphia
    University of Pennsylvania, Basser Research Center for BRCA
    Principal Investigator: Susan Domchek, MD
    Contact Name: Rebecca Cimildoro, RN
    Contact Phone: 215-662-7383
  • Pittsburgh
    UPMC Cancer Center
    Magee Women's Hospital
    Principal Investigator: Shannon Puhalla, MD
    Contact Name: Shannon Puhalla, MD at: puhallasl@upmc.edu
    Study Coordinator: Brenda Lee Steele
    Contact Phone: 412-641-2261

South Carolina

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

Tennessee

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

Texas

  • Dallas
    Principal Investigator: Dr. Barbara Haley
    Contact Name: Todd Morgan
    Contact Number: 469-250-8369
  • Houston
    The Methodist Hospital
    Principal Investigator: Dr. Jenny Chang
    Contact Name: Maria Nina Salazar
    Contact Number : 713-441-0629

 



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