Triple Negative Trial: A Randomised Phase III Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic or Recurrent Locally Advanced ER-, PR- and HER2- Breast Cancer.
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