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NCT01042379

I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to TreatBreast Cancer

Study identifier: NCT01042379
Full study details on clinicaltrials.gov

Name of PARP Inhibitor used in study:

Veliparib (Abbott)

Eligibility:

• Histologically confirmed invasive cancer of the breast
• Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)
• Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed
• Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
•Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
• Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis

Type of study:

Phase II randomized trial

The I-SPY 2 trial will use genetic or biological markers (“biomarkers”) from individual patients’ tumors to screen promising new treatments, identifying which treatments are most effective in specific types of patients. In addition, an adaptive trial design will enable researchers to use early data from one set of patients to guide decisions about which treatments might be more useful for patients later in the trial, and eliminate ineffective treatments more quickly.

Treatment:

The treatment phase of this trial will be testing multiple investigational drugs that are thought to target the biology of each participant’s tumor. The trial will use the information from each participant who completes the study treatment to help decide treatment for future women who join the trial. This will help the study researchers learn more quickly which investigational drugs will be most beneficial for women with certain tumor characteristics. The I-SPY 2 TRIAL will test the idea of tailoring treatment by using molecular tests to help identify which patients should be treated with investigational drugs. Results of this trial may help make investigational drugs available to more women in the future.

Treatment medications include combinations of the following:

Figitumumab: Experimental, an IGFR inhibitor
Novel investigational agent
20 mg/kg IV every 3 weeks during the 12 weekly treatment cycles post-randomization
Other Name: CP-751,871

Neratinib: Experimental, a Pan ErbB inhibitor
Novel investigational agent
240 mg orally every week during the 12 weekly treatment cycles post-randomization

ABT-888: Experimental, A PARP Inhibitor
ABT-888: 50 mg orally twice daily during the 12 weekly treatment cycles post-randomization
Carboplatin:  IV every three weeks for four weeks during the 12 weekly treatment cycles post-randomization

Standard Therapy: Active Comparator
Paclitaxel, Herceptin followed by Doxorubicin and Cyclophosphamide treatment depending on HR/HER-2 status.

Paclitaxel: 80 mg/m2 IV during the 12 weekly treatment cycles post randomization Doxorubicin: 60 mg/m2 IV after completion of the 12 weekly treatment cycles and prior to surgery for weeks 13-16 Cyclophosphamide: 600 mg/m2 IV after completion of the 12 weekly treatment cycles and prior to surgery for weeks 13-16

AMG 386: Experimental, AMG 386, an angiogenesis inhibitor

Novel investigational agent
15 mg/kg IV every week during 12 weekly treatment cycles post-randomization

Conatumumab: Experimental, an APO/TRAIL inhibitor
Novel investigational agent
10 mg/kg IV every other week during 12 weekly treatment cycles post-randomization
Other Name: AMG 655

Study sites:

Arizona
Mayo Clinic - Scottsdale Recruiting
Scottsdale, Arizona, 85259
Contact 507-538-7623
Principal Investigator: Donald Northfelt, MD

California
University of California San Diego
La Jolla, California, 92093-0698
Contact: Cynthia Meyer 858-822-6575 cjmeyer@ucsd.edu
Contact 858-822-5354 CancerCTO@ucsd.edu
Principal Investigator: Anne Wallace, MD

University of Southern California
Los Angeles, California, 90033
Contact: Debu Tripathy, MD 323-865-3900 Tripathy@usc.edu
Contact: Kristy Watkins, RN 323-865-0452 Watkins_K@ccnt.usc.edu
Principal Investigator: Debasish Tripathy, MD

University of California San Francisco (UCSF)
San Francisco, California, 94115
Contact 877-827-3222
Principal Investigator: Amy Jo Chien, MD

Colorado
University of Colorado
Aurora, Colorado, 80045
Contact: Caroline Jamison 720-848-3428 Caroline.Jamison@ucdenver.edu
Principal Investigator: Anthony Elias, MD

District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Contact: Minetta Liu, MD 202-444-3677 Liumc@georgetown.edu

Georgia
Emory University
Atlanta, Georgia, 30322
Contact: Latisha Pace 404-778-1559 lrpace@emory.edu
Principal Investigator: William C Wood, MD

Illinois
University of Chicago
Chicago, Illinois, 60453
Contact 773-834-7424
Principal Investigator: Olufunmilayo Olopade, MD

Loyola University
Maywood, Illinois, 60153
Contact: Kathy Czaplicki 708-327-3322 kczapli@lumc.edu
Contact: Agnes Natonton 708-327-2237 anatont@lumc.edu
Principal Investigator: Kathy Albain, MD

Kansas
University of Kansas
Westwood, Kansas, 66205
Contact: Cinda Lyon, RN 913-588-2567 clyon@kumc.edu
Principal Investigator: Qamar Khan, MD

Minnesota
University of Minnesota
Minneapolis, Minnesota, 55455
Contact: Tufia Haddad, MD 612-625-4918
Principal Investigator: Tufia Haddad, MD
Mayo Clinic Recruiting

Rochester, Minnesota, 55905
Contact 507-538-7623
Principal Investigator: Judy C Boughey, MD

Oregon
Oregon Health & Science Institute (OHSU)
Portland, Oregon, United States, 97239
Contact: Stephen Y Chui, MD 503-494-8534
Principal Investigator: Stephen Y Chui, MD

Pennsylvania
University of Pennsylvania (U Penn)
Philadelphia, Pennsylvania, 19104
Contact: Luke Velders 215-615-6821 Luke.Velders@uphs.upenn.edu
Principal Investigator: Angela DeMichele, MD

Texas
University of Texas, Southwestern Medical Center
Dallas, Texas, 75390-9155
Contact: David Euhus, MD 214-648-6467
Principal Investigator: David Euhus, MD

Virginia
Inova Health System
Falls Church, Virginia, 22042
Contact: Alyssa Bruflodt 703-776-3565 Alyssa.Bruflodt@inova.org
Principal Investigator: Kirsten Edmiston, MD, FACS

Washington
Swedish Cancer Institute
Seattle, Washington, 98104
Contact: Yolanda Seegmiller 206-215-5962 Yolonda.Seegmiller@Swedish.org
Contact: Heather Sloan 206-386-3650 Heather.Sloan@Swedish.org
Principal Investigator: Hank Kaplan, MD


Page updated 08/31/11