Triple Negative Breast Cancer Trial (TNT)
This study is currently recruiting participants.
Verified August 2009 by Institute of Cancer Research, United Kingdom
Sponsor:
Institute of Cancer Research, United Kingdom
Collaborators:
King's College London
Cancer Research UK
Breakthrough Breast Cancer
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT00532727
First received: September 19, 2007
Last updated: October 12, 2012
Last verified: August 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Carboplatin Drug: Docetaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by Institute of Cancer Research, United Kingdom:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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)
| Estimated Enrollment: | 400 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532727
Contacts
| Contact: TNT Trial Manager | 44-20-8722-4152 | tnt-icrctsu@icr.ac.uk |
Locations
| United Kingdom | |
| Guy's and St Thomas' Hospital NHS Foundation Trust | Recruiting |
| 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
| Principal Investigator: | Andrew Tutt, MB ChB, MRCP, FRCR, PhD | King's College London |
More Information
No publications provided
| Responsible Party: | Institute of Cancer Research, United Kingdom |
| ClinicalTrials.gov Identifier: | NCT00532727 History of Changes |
| Other Study ID Numbers: | ICR-CTSU/2006/10003, ISRCTN97330959, Main REC: 07/Q0603/67, CTA: 22138/0004/001-0001, EudraCT Number: 2006-004470-26 |
| Study First Received: | September 19, 2007 |
| Last Updated: | October 12, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee |
Keywords provided by Institute of Cancer Research, United Kingdom:
|
Breast Cancer Triple Negative |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Docetaxel Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013