Triple Negative Breast Cancer
Conditions
Keywords
Oncology, Triple negative breast cancer, German Breast Group - GBG 81, United States Oncology - 12152, National Surgical Adjuvant Breast and Bowel Project - B-56-I, Alliance - AFT-04, Grupo Español de Investigación en Cáncer de Mama - GEICAM/2014-02
Brief summary
This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.
Interventions
DRUGCyclophosphamide
Cyclophosphamide
DRUGPlacebo
Placebo for Carboplatin
DRUGDoxorubicin
Doxorubicin
DRUGPaclitaxel
Paclitaxel
DRUGCarboplatin
Carboplatin
DRUGVeliparib
Veliparib
Sponsors
GBG Forschungs GmbH
NSABP Foundation Inc
Grupo Español de Investigación del Cáncer de Mama
US Oncology Research
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR). | At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug). | Pathological complete response (pCR) in the breast tissue and the lymph node tissue will be assessed upon completion of pre-operative systemic therapy and definitive surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event Free Survival (EFS) | Up to 4 years from the date of definitive surgery. | EFS will be defined as the time from random assignment to documentation of the first of the following events: discontinuation of study therapy due to protocol-defined progression prior to surgery; local, regional, or distant recurrence of breast cancer following curative surgery; a new breast cancer; another new onset malignancy; or death as a result of any cause. |
| Overall Survival (OS) | Up to 4 years from the date of definitive surgery. | OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death. |
| Rate of eligibility for breast conservation after therapy (BCR). | At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug). | Whether a subject is eligible for breast conserving surgery for whom mastectomy was planned at diagnosis will be determined by the subject's surgeon prior to chemotherapy and after completion of chemotherapy. |
Countries
Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Outcome results
None listed