Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer
This study is not yet open for participant recruitment.
Verified March 2012 by Instituto Nacional de Cancerologia de Mexico
Sponsor:
Instituto Nacional de Cancerologia de Mexico
Collaborator:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Information provided by (Responsible Party):
Claudia Arce Salinas, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier:
NCT01566799
First received: March 22, 2012
Last updated: March 29, 2012
Last verified: March 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 22, 2012 | ||||||||
| Last Updated Date | March 29, 2012 | ||||||||
| Start Date ICMJE | April 2012 | ||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
pathologic complete response [ Time Frame: pCR will be assesed after 24 weeks of treatment ] [ Designated as safety issue: No ] to assess the efficacy in terms of pahtologic complete response in patients with locally advanced breast cancer, treated with neoadjuvant chemotherapy based on Paclitaxel followed by FAC, combined with metformin or placebo |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01566799 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer | ||||||||
| Official Title ICMJE | Clinical Phase II, Randomized, Double Blind Trial, to Evaluate the Efficacy of Metformin and Chemotherapy Versus Placebo Nad Chemotherapy in Neoadjuvant Setting for Locally Advanced Breast Cancer | ||||||||
| Brief Summary | Background Obesity and overweight are well known risk factors for breast cancer and also are associated with higher recurrence and mortality rates. Main goal of this study is to evaluate the efficacy of metformin plus chemotherapy in terms of pathologic complete response in comparison with placebo plus the same chemotherapy regimen Design: Randomized, double blind, clinical trial. This study will be performed at National Cancer Institute of Mexico City, at breast cancer unit. Patients with ER+ or PR+, HER2 negative, breast cancer are candidates to participate. After completion of chemotherapy all patients will have a breast surgery to assess pathologic response. Complete pathologic response is defined as the abscence of malignant cells in breast tissue and lymph nodes. The presence of DCIS is considered as pCR |
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| Detailed Description | Definitions Luminal A: tumors ER + PR + HER2 Negative and Ki67 <14% Luminal B: tumors ER +/-, PR +/-, HER2 negative and Ki67 >15% Complete pathologic response is defined as the abscence of malignant cells in breast tissue and lymph nodes. The presence of DCIS is considered as pCR |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Locally Advanced Malignant Neoplasm | ||||||||
| Intervention ICMJE | Drug: Metformin
metformin 500 mg/day po for 24 weeks.
Other Name: Dabex |
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| Study Arm (s) | Experimental: Metformin
Patients will be receive 12 weeks of paclitaxel followed by 4 cycles of FAC combined with 500 mg/day of metformin p.o.
Intervention: Drug: Metformin |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | April 2014 | ||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Mexico | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01566799 | ||||||||
| Other Study ID Numbers ICMJE | MET-INCAN-1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Claudia Arce Salinas, Instituto Nacional de Cancerologia de Mexico | ||||||||
| Study Sponsor ICMJE | Instituto Nacional de Cancerologia de Mexico | ||||||||
| Collaborators ICMJE | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | ||||||||
| Investigators ICMJE |
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| Information Provided By | Instituto Nacional de Cancerologia de Mexico | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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