Randomised, Phase 3 study for subjects with Early Stage TNBC
Research type
Research Study
Full title
A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating 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 Triple Negative Breast Cancer (TNBC)
IRAS ID
149700
Contact name
Daniel Kreeb
Contact email
Sponsor organisation
Abbvie Deutschland GmbH & Co. KG
Eudract number
2013-002377-21
Duration of Study in the UK
12 years, 0 months, 1 days
Research summary
Breast cancer is the most common cancer in women worldwide. The majority of breast cancer is diagnosed before the spread of the disease in the body. Survival for early breast cancer is improved with the addition of chemotherapy and/or radiotherapy to surgery for all but small, localised tumours.
Laboratory and animal studies have shown that Poly (ADP-ribose)-polymerase (PARP) is a protein inside cells that recognises DNA damage and facilitates DNA repair. DNA-damaging agents, including chemotherapy and radiation therapy, are the main treatments available for breast cancer. Since cancer cells are unstable, they are more sensitive than normal tissues to chemotherapy and radiation therapy. PARP inhibitors have been shown to sensitise tumours to a variety of DNA-damaging agents, including chemotherapy agents such as carboplatin and radiation therapy. Veliparib is a potent PARP inhibitor that delays the repair of DNA damage induced by chemotherapy. Veliparib increases sensitivity of tumour cells to chemotherapy and radiation therapy.
This study will consist of adult women with previously untreated triple negative breast cancers who are candidates for potentially curative surgery.
The purpose of this study is to assess if veliparib is safe and if it works to reduce the size of the tumour before women receive surgery in breast cancer. In addition, substances found in the blood, and tissue (biomarkers) that may indicate the effects or progress of the breast cancer and the activity of veliparib will be studied.
Participation in the study is expected to last approximately 7 months and includes about 40 visits to the research centre with post treatment follow up every 6 months thereafter for 10 years. Blood tests, scans, biopsies and answering multiple patient questionnaires will be required throughout the study. The study will include approximately 624 patients across Europe, North America, Australia and Taiwaan.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/0273
Date of REC Opinion
12 May 2015
REC opinion
Further Information Favourable Opinion