Trial Search Results

A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

The purpose of this study is to see if adding veliparib and/or carboplatin to standard neoadjuvant chemotherapy can help shrink TNBC faster, and lower the risk of the cancer coming back in other parts of the body.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AbbVie

Collaborator: Alliance for Clinical Trials in Oncology

Intervention(s):

  • Drug: Cyclophosphamide
  • Drug: Placebo
  • Drug: Doxorubicin
  • Drug: Paclitaxel
  • Drug: Carboplatin
  • Drug: Veliparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy
   (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical
   exam or radiologic studies.

   2. Documented Breast Cancer Gene (BRCA) germline mutation testing.

   3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth
   Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.

   4. ECOG Performance status of 0 to 1.

   5. Women must be determined to be not of childbearing potential (surgically sterile, or
   postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR
   they must have a negative serum pregnancy test prior to randomization.

Exclusion Criteria:

   1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic
   therapy radiotherapy or investigational agents) with therapeutic intent for current
   breast cancer.

   2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a
   Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.

   3. Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal
   agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator
   (SERM). Subjects must have discontinued use of such agents prior to beginning study
   treatment.

   4. A history of seizure within 12 months prior to study entry.

   5. Pre-existing neuropathy from any cause in excess of Grade 1.

Ages Eligible for Study

18 Years - 99 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting