Locally Advanced Malignant Neoplasm
Conditions
Keywords
Locally advanced breast cancer, Neoadjuvant chemotherapy, Metformin, Pathologic Complete Response
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
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
Interventions
DRUGMetformin
metformin 500 mg/day po for 24 weeks.
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Cancerologia de Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathologic complete response | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety analysis | after 24 treatment weeks' | For safety analysis we are going to use NCTC criteria version 3.0 |
| Assess clinical response at the end of paclitaxel and at the end of neoadjuvant chemotherapy | after 24 treatment weeks' | tumor measurements by caliper every cycle and by ultrasound at the end of chemotherapy |
| To correlate serum levels of insulin, protein C and HbA1 (after treatment) with clinical and pathologic response | safter 24 treatment weeks' | correlation between serum levels of insuline levels, HbA1 and PCR and PCR |
Countries
Mexico
Contacts
Primary ContactClaudia Arce, MD, MSc
Backup ContactJulieta Santamaria, Nurse
Outcome results
None listed