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.

Institute of Cancer Research, United Kingdom1 site in 1 country400 target enrollmentJanuary 2008

ConditionsBreast Cancer

InterventionsCarboplatin Docetaxel

DrugsCarboplatin Docetaxel

Overview

Phase: Phase 3
Intervention: Carboplatin
Conditions: Breast Cancer
Sponsor: Institute of Cancer Research, United Kingdom
Enrollment: 400
Locations: 1
Primary Endpoint: 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.
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

March 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

Institute of Cancer Research, United Kingdom

Responsible Party

Sponsor

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)

Arms & Interventions

Arm A

Carboplatin

Intervention: Carboplatin

Arm B

Docetaxel

Intervention: Docetaxel

Outcomes

Primary Outcomes

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 Frame: Time from start of treatment to 18 weeks

Secondary Outcomes

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)
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)
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)