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: Grupo Espanol de Investigacion del Cancer de Mama
Stanford Investigator(s):
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