Triple Negative Breast Cancer Trial - Full Text View

Sponsors and Collaborators:	Institute of Cancer Research, United Kingdom King's College London Cancer Research UK Breakthrough Breast Cancer
Information provided by:	Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:	NCT00532727

Purpose

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 III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Carboplatin Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
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.

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:	January 2014
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Experimental Carboplatin	Drug: Carboplatin AUC 6 every 3 weeks for six cycles (18 weeks)
Arm B: Active Comparator 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: Hannah Baker

44-20-8722-4156

hannah.baker@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

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	King's College London ( Dr Andrew Tutt )
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:	January 22, 2008
ClinicalTrials.gov Identifier:	NCT00532727
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

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Breast Neoplasms

Carboplatin
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009