ISRCTN10059974
Completed
Phase 2
A randomised phase II study of cytotoxic chemotherapy or cytotoxic chemotherapy combined with celecoxib or trastuzumab as primary chemotherapy for patients with high risk localised breast cancer not amenable to breast conserving therapy
Remagus (France)0 sites340 target enrollmentFebruary 8, 2007
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- ocalised breast cancer not amenable to breast conserving therapy
- Sponsor
- Remagus (France)
- Enrollment
- 340
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
- 2010 results on pre- and post- therapy detection of circulating tumor cells in http://www.ncbi.nlm.nih.gov/pubmed/19850639 2. 2010 main results in http://www.ncbi.nlm.nih.gov/pubmed/20480225 3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21525400 4. 2019 results in http://www.ncbi.nlm.nih.gov/pubmed/30702971 [added 01/02/2019]
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Pathologically proven T1c\-T4, N0\-N1, M0 invasive breast cancer (Tumour, Nodes, Metastasis \[TNM] classification)
- •2\. No prior therapy
- •3\. Age 18 to 65 years
- •4\. Available frozen tumour tissue
- •5\. Written informed consent
Exclusion Criteria
- •1\. Male patient
- •2\. Prior therapy for breast cancer
- •3\. Contraindication to study drug(s)
- •4\. Stage IV breast cancer
Outcomes
Primary Outcomes
Not specified
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