Triple Negative Breast Cancer Trial (TNT)

Institute of Cancer Research, United Kingdom

Status and phase

Unknown

Phase 3

Conditions

Breast Cancer

Treatments

Drug: Docetaxel

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00532727

EudraCT Number: 2006-004470-26

Main REC: 07/Q0603/67

CTA: 22138/0004/001-0001

ICR-CTSU/2006/10003

ISRCTN97330959

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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