Clinical trial NCT01566799: Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Malignant Neoplasm
Keywords: Locally advanced breast cancer
Neoadjuvant chemotherapy
Metformin
Pathologic Complete Response
Lead sponsor: Instituto Nacional de Cancerologia de Mexico
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
First posted: 2012-03-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: pathologic complete response
timeFrame: pCR will be assesed after 24 weeks of treatment
Secondary outcomes:
measure: Safety analysis
timeFrame: after 24 treatment weeks'
measure: Assess clinical response at the end of paclitaxel and at the end of neoadjuvant chemotherapy
timeFrame: after 24 treatment weeks'
measure: To correlate serum levels of insulin, protein C and HbA1 (after treatment) with clinical and pathologic response
timeFrame: safter 24 treatment weeks'
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional Cancerologi
state: Distrito Federal
Study officials:
affiliation: Instituto Nacional Canerologia
name: Claudia Arce, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: