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Triple Negative Breast Cancer Trial (TNT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00532727
Recruitment Status : Unknown
Verified February 2019 by Institute of Cancer Research, United Kingdom.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2007
Last Update Posted : February 20, 2019
Sponsor:
Collaborators:
King's College London
Cancer Research UK
Breakthrough Breast Cancer
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Carboplatin Drug: Docetaxel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : January 2008
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532727


Locations
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United Kingdom
Guy's and St Thomas' Hospital NHS Foundation Trust
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
King's College London
Cancer Research UK
Breakthrough Breast Cancer
Investigators
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Principal Investigator: Andrew Tutt, MB ChB, MRCP, FRCR, PhD King's College London
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT00532727    
Other Study ID Numbers: ICR-CTSU/2006/10003
ISRCTN97330959
Main REC: 07/Q0603/67
CTA: 22138/0004/001-0001
EudraCT Number: 2006-004470-26
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Keywords provided by Institute of Cancer Research, United Kingdom:
Breast Cancer
Triple Negative
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
 Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action