Triple Negative Breast Cancer Trial

Recruitment & Eligibility

Inclusion Criteria

Histologically confirmed ER-, PR-, primary breast cancer
Histologically confirmed HER2- primary breast cancer
Measurable confirmed metastatic or recurrent locally advanced disease unsuitable for local therapy but suitable for taxane chemotherapy
Patients with stable, treated bain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present.
Patients with bone metastases currently receiving bisphosphonates for palliation will be eligible providing informed consent can be given and that other sites of measurable disease are present
ECOG Performance Status 0, 1, or 2
Adequate haematology, biochemical indices (FBC, U & Es)
LFTs = Normal bilirubin, AST and/or ALT = 3 x ULN if Alk Phos >5 x ULN (or an isolated elevation AST/ALT of ≤5 x ULN
Adequate renal function - Creatinine clearance of >25mls per minute
Written informed consent, able to comply with treatment and follow up

Exclusion Criteria

Original primary tumour or subsequent relapse known to be positive for any of ER, PR, or HER2 receptors
Patients unfit for chemotherapy or those with neuropathy >grade 1 (sensory or motor)
Known allergy to platinum compounds or to mannitol
Known sensitivity to taxanes
Patients with inoperable locally advanced disease suitable for local radiotherapy or an anthracycline containing regimen
Previous chemotherapy for metastatic disease other than an anthracycline as in inclusion criteria above
Previous exposure to a taxane in adjuvant chemotherapy within 12 months of trial entry
Previous treatment with a taxane for recurrent locally advanced disease
Previous treatment with a platinum chemotherapy drug
LFTs = Abnormal bilirubin (> ULN), AST and/or ALT >3 X ULN and Alk Phos >5 x ULN (or an isolated elevation AST/ALT of >5 x ULN)
Patients with a life expectancy of less than 3 months
Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous call carcinoma of the skin, unless there has been a disease free interval of at least 10 years
Previous or synchronous second breast cancer (unless also confirmed ER-, PR- and HER2-)
Patients with bone limited disease
Other serious uncontrolled medical conditions or concurrent medical illness likely to compromise life expectancy and/or the completion of trial therapy
Pregnant, lactating or potentially childbearing women not using adequate contraception

Study & Design

Arm && Interventions

Group	Intervention	Description
Arm A	Carboplatin	Carboplatin
Arm B	Docetaxel	Docetaxel

Primary Outcome Measures

Name	Time	Method
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 from start of treatment to 18 weeks

Secondary Outcome Measures

Name	Time	Method
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 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 from start of treatment until confirmation of progression or death
Overall survival: this will be defined as time from randomisation until death from any cause in the intention to treat population	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 from start of treatment to 18 weeks
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 from randomisation to discontinuation of protocol treatment for any reason, or progression of disease

Recruitment & Eligibility