This is a trial of carboplatin compared to docetaxel for patients with metastatic or recurrent locally advanced ER-, PR- and HER2- breast cancer

• Conditions: metastatic or recurrent locally advanced breast cancer thatis ER-, PR- (or unknown) and HER2- or known BRCA1/BRCA2 carriers.; MedDRA version: 13.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-004470-26-GB
• Lead Sponsor: The Institute of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

•Either:
• Histologically confirmed ER-, PR-, HER2- primary invasive breast cancer
Allred/quick score <3 or H score <10 or ER and PR negative, if other cut-offs used (e.g., 1%, 5% or
10%), see Appendix 3. HER2 negative defined as immunohistochemistry scoring 0 or 1+ for
HER2, or 2+ and non-amplified for HER2 gene by FISH or CISH; see Appendix 3.
or:
• PR unknown but ER- and HER2-, and otherwise eligible. Please arrange urgent PR
testing. If PR unknown and PR testing is not possible within a reasonable timeframe,
the patient is eligible for the trial provided that ER and HER2 status are negative and
all other eligibility criteria are met.
or:
• Confirmed BRCA1 or 2 mutation carrier, with any ER, PR and HER2 status
plus:
• Measurable confirmed metastatic or recurrent locally advanced disease unsuitable for
local therapy but suitable for taxane chemotherapy.
TNT Protocol Version 3.0, 18 June 2009
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NB: Patients who have not received anthracycline based chemotherapy in the
adjuvant setting or for locally advanced disease may have received a non-taxane,
anthracycline regimen as their first treatment at relapse and are eligible to enter the
trial at confirmed progression after the anthracycline treatment
• Patients with stable, treated brain 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 other sites of measurable disease are present
• ECOG Performance Status 0, 1 or 2 (see Appendix 4)
• 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 – Glomerular Filtration Rate (GFR) of >25mls per minute
(see Appendix 5)
• Written informed consent, able to comply with treatment and follow-up.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

Exclusion Criteria

Original primary tumour or subsequent relapse known to be positive for any of ER,
PR, or HER2 receptors (defined above and in Appendix 3) unless patient is a known
BRCA1 or BRCA 2 mutation carrier
• 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 which was
not completely excised.
• Previous treatment with a platinum chemotherapy drug
• LFTs = Abnormal bilirubin (> ULN) and/or AST and/or ALT >3 x ULN with 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
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• Previous malignancies other than adequately treated in situ carcinoma of the uterine
cervix or basal or squamous cell 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-
/unknown 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
(documentation of a negative serum HCG pregnancy test should be available for premenopausal
women with intact reproductive organs, or women less than two years
after the menopause. Fertile women and their partners must use a medically
acceptable contraceptive throughout the treatment period and for six months following
cessation of treatment. Subjects must be made aware before entering the trial of the
risk in becoming pregnant).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified