Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer

Instituto Nacional de Cancerologia de Mexico

Status and phase: Unknown; Phase 2

Conditions: Locally Advanced Malignant Neoplasm

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01566799

MET-INCAN-1

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

---

60 participants in 1 patient group

Metformin

Experimental group

Description:

Patients will be receive 12 weeks of paclitaxel followed by 4 cycles of FAC combined with 500 mg/day of metformin p.o.

Treatment:

Drug: Metformin