Triple Negative Breast Cancer Trial

Study Overview
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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.

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Docetaxel


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Carboplatin | Drug: Carboplatin<br>* AUC 6 every 3 weeks for six cycles (18 weeks)<br>|
| Active Comparator: Arm B<br>Docetaxel | Drug: Docetaxel<br>* 100mg/m2 every 3 weeks for six cycles (18 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Time from start of treatment to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Time from start of treatment until confirmation of progression | 
| 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 from start of treatment until confirmation of progression or death | 
| 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 |  | Time from randomisation to discontinuation of protocol treatment for any reason, or progression of disease | 
| Overall survival: this will be defined as time from randomisation until death from any cause in the intention to treat population |  | Time from randomisation until death from any cause | 
| 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) |  | Time from start of treatment to 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Triple Negative