M12-914 Phase III Veliparib/Placebo + C/P Breast Cancer Study
Research type
Research Study
Full title
A Phase III Randomized Placebo-Controlled Trial of Carboplatin and Paclitaxel with or without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer
IRAS ID
152549
Contact name
Stephen Chan
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co.KG
Eudract number
2014-000345-70
Research summary
Breast cancer is diagnosed in over 1.3 million women worldwide each year and accounts for approximately 500,000 deaths, making it one of the most common cancers in women. Although the number of drugs approved for the treatment of breast cancer continues to increase, overall survival of metastatic (cancer that has spread) breast cancer has changed very little, and thus improved therapies are needed.
Carboplatin and Paclitaxel are approved chemotherapy drugs for use in the UK and other countries. However, Carboplatin is not currently approved in the UK for the treatment of breast cancer in combination with Paclitaxel (though it is approved in other countries), and is considered to be experimental. Veliparib is a 'PARP inhibitor' that may make chemotherapy better at killing cancer cells, and earlier trials have suggested a beneficial effect of PARP inhibitors in BRCA-deficient cancers.
This is a Phase III, randomised, double-blinded trial (neither the patient nor the doctor knows whether the patient is taking veliparib or placebo). All patients will receive both carboplatin and paclitaxel. Two thirds of the patients will also receive veliparib and the other third will receive placebo (substance that looks the same as veliparib but has no active ingredients). The trial will see which treatment is better at controlling the cancer, by measuring the progression-free time as well as the overall survival.
Patients could benefit if tumour growth is inhibited, therefore improving their condition and survival time. Information gathered may help improve future treatment of the disease.
Patients will attend hospital for regular study visits and may receive treatment for more than a year. The effect of the treatments on the cancer will be checked by having scans, blood tests, checking for side effects and completing questionnaires. Patients will also have the option to participate in additional tissue and genetics studies.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
14/EM/0215
Date of REC Opinion
24 Jul 2014
REC opinion
Further Information Favourable Opinion