Triple Negative Breast Cancer Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Carboplatin

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

AUC 6 every 3 weeks for six cycles (18 weeks)

Arm B

Docetaxel

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

100mg/m2 every 3 weeks for six cycles (18 weeks)

Interventions

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Carboplatin

AUC 6 every 3 weeks for six cycles (18 weeks)

Intervention Type DRUG

Docetaxel

100mg/m2 every 3 weeks for six cycles (18 weeks)

Intervention Type DRUG

Eligibility Criteria

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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

* 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

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No