Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer
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
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Distrito Federal
-
Mexico, Distrito Federal, Mexico, 14080
- Instituto Nacional Cancerologi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Women older than 18 years old and younger than 70 years old
- Invasive breast cancer confirmed by core biopsy, any histology
- Tumor ≥2 cm and/or lymph node positive (proven by FNA)(T2-4b, N0-3, M0)
- Must have ER/PR positive and HER2 negative
- Must have full staging and extent disease and clinically and radiographically tumor measure
- Without previous treatment for breast cancer (including surgery, hormonotherapy or chemotherapy)
- Normal liver, kidney and blood tests
- Performance Status ECOG 0-2 o Karnofsky ≥70%
- Fasten glucose levels <125 mg/dl
- Signed consent
Exclusion Criteria:
- Previous use of metformin for any indication
- Presence of Diabetes Mellitus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
metformin 500 mg/day po for 24 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pathologic complete response
Time Frame: pCR will be assesed after 24 weeks of treatment
|
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
|
pCR will be assesed after 24 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety analysis
Time Frame: after 24 treatment weeks'
|
For safety analysis we are going to use NCTC criteria version 3.0
|
after 24 treatment weeks'
|
|
Assess clinical response at the end of paclitaxel and at the end of neoadjuvant chemotherapy
Time Frame: after 24 treatment weeks'
|
tumor measurements by caliper every cycle and by ultrasound at the end of chemotherapy
|
after 24 treatment weeks'
|
|
To correlate serum levels of insulin, protein C and HbA1 (after treatment) with clinical and pathologic response
Time Frame: safter 24 treatment weeks'
|
correlation between serum levels of insuline levels, HbA1 and PCR and PCR
|
safter 24 treatment weeks'
|
Collaborators and Investigators
Investigators
- Principal Investigator: Claudia Arce, MD, MSc, Instituto Nacional Canerologia
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MET-INCAN-1
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