Triple Negative Breast Cancer Trial (TNT)

February 18, 2019 updated by: Institute of Cancer Research, United Kingdom

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Frame: Time from start of treatment to 18 weeks
Time from start of treatment to 18 weeks

Secondary Outcome Measures

Outcome Measure
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 Frame: Time from start of treatment until 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 Frame: Time from start of treatment until 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 Frame: Time from randomisation to discontinuation of protocol treatment for any reason, or progression of disease
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 Frame: Time from randomisation until death from any cause
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 Frame: Time from start of treatment to 18 weeks
Time from start of treatment to 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

King's College London
Cancer Research UK
Breakthrough Breast Cancer

Investigators

  • Principal Investigator: Andrew Tutt, MB ChB, MRCP, FRCR, PhD, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

March 1, 2016

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

September 19, 2007

First Submitted That Met QC Criteria

September 19, 2007

First Posted (Estimate)

September 20, 2007

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICR-CTSU/2006/10003
  • ISRCTN97330959
  • Main REC: 07/Q0603/67
  • CTA: 22138/0004/001-0001
  • EudraCT Number: 2006-004470-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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