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Triple Negative Breast Cancer Trial (TNT)

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ClinicalTrials.gov Identifier: NCT00532727
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE September 19, 2007
First Posted Date  ICMJE September 20, 2007
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE January 2008
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2007)
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.
Change History Complete list of historical versions of study NCT00532727 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
  • 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 ]
  • 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 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2007)
  • 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
  • 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 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
  • Overall survival: this will be defined as time from randomisation until death fom any cause in the intention to treat population
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Triple Negative Breast Cancer Trial
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Carboplatin
    AUC 6 every 3 weeks for six cycles (18 weeks)
  • Drug: Docetaxel
    100mg/m2 every 3 weeks for six cycles (18 weeks)
Study Arms  ICMJE
  • Experimental: Arm A
    Carboplatin
    Intervention: Drug: Carboplatin
  • Active Comparator: Arm B
    Docetaxel
    Intervention: Drug: Docetaxel
Publications * Tutt A, Tovey H, Cheang MCU, Kernaghan S, Kilburn L, Gazinska P, Owen J, Abraham J, Barrett S, Barrett-Lee P, Brown R, Chan S, Dowsett M, Flanagan JM, Fox L, Grigoriadis A, Gutin A, Harper-Wynne C, Hatton MQ, Hoadley KA, Parikh J, Parker P, Perou CM, Roylance R, Shah V, Shaw A, Smith IE, Timms KM, Wardley AM, Wilson G, Gillett C, Lanchbury JS, Ashworth A, Rahman N, Harries M, Ellis P, Pinder SE, Bliss JM. Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial. Nat Med. 2018 May;24(5):628-637. doi: 10.1038/s41591-018-0009-7. Epub 2018 Apr 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2007)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00532727
Other Study ID Numbers  ICMJE ICR-CTSU/2006/10003
ISRCTN97330959
Main REC: 07/Q0603/67
CTA: 22138/0004/001-0001
EudraCT Number: 2006-004470-26
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institute of Cancer Research, United Kingdom
Study Sponsor  ICMJE Institute of Cancer Research, United Kingdom
Collaborators  ICMJE
  • King's College London
  • Cancer Research UK
  • Breakthrough Breast Cancer
Investigators  ICMJE
Principal Investigator: Andrew Tutt, MB ChB, MRCP, FRCR, PhD King's College London
PRS Account Institute of Cancer Research, United Kingdom
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP