Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments carboplatin, docetaxel
Phase phase 3
Sponsor Institute of Cancer Research, United Kingdom
Collaborator King's College London
Start date January 2008
End date July 2014
Trial size 400 participants
Trial identifier NCT00532727, CTA: 22138/0004/001-0001, EudraCT Number: 2006-004470-26, ICR-CTSU/2006/10003, ISRCTN97330959, Main REC: 07/Q0603/67

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Carboplatin
carboplatin
AUC 6 every 3 weeks for six cycles (18 weeks)
(Active Comparator)
Docetaxel
docetaxel
100mg/m2 every 3 weeks for six cycles (18 weeks)

Primary Outcomes

Measure
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.
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Secondary Outcomes

Measure
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
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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 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
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Overall survival: this will be defined as time from randomisation until death fom any cause in the intention to treat population
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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)
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Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title 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.
Principal investigator Andrew Tutt, MB ChB, MRCP, FRCR, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Institute of Cancer Research, United Kingdom.