The purpose of this study is to determine whether there is greater activity for carboplatin than a taxane standard of care (docetaxel) in women with ER-, PR- and HER2- breast cancer. The trial aims to recruit between 370 and 450 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
AUC 6 every 3 weeks for six cycles (18 weeks)
100mg/m2 every 3 weeks for six cycles (18 weeks)
Guy's and St Thomas' Hospital NHS Foundation Trust
London, United Kingdom
Response: Response will be evaluated after three and six cycles of chemotherapy using modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria, with appropriate clinical assessment and radiological investigations.
Time frame: Time from start of treatment to 18 weeks
Time to progression: this will be defined according to RECIST criteria and will be measured from the start of treatment until the confirmation of progression
Time frame: Time from start of treatment until confirmation of progression
Progression free survival: this will be defined according to RECIST criteria and will be measured from the start of treatment until the confirmation of progression or death.
Time frame: Time from start of treatment until confirmation of progression or death
Time to treatment failure: this will be defined as time from randomisation to discontinuation of protocol treatment for any reason, or progression of disease as defined by RECIST
Time frame: Time from randomisation to discontinuation of protocol treatment for any reason, or progression of disease
Overall survival: this will be defined as time from randomisation until death from any cause in the intention to treat population
Time frame: Time from randomisation until death from any cause
Toxicity will be assessed throughout the treatment period using the National Cancer Institute Common Terminology Criteria for Adverse Events version three (NCI CTCAE v3.0)
Time frame: Time from start of treatment to 18 weeks
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