Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Institute of Cancer Research - Sutton

Andrew Tutt, MB ChB, MRCP, FRCR, PhD

Principal Investigator

TNT Trial Manager		Ph: 44-20-8722-4152
		Email: tnt-icrctsu@icr.ac.uk

United Kingdom
	London
	Guy's Hospital

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00532727
Information obtained from ClinicalTrials.gov on November 20, 2012

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