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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


Phase 2
18 Years
70 Years
Not Enrolling
Female
Locally Advanced Malignant Neoplasm

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

pathologic complete response

Outcome Description:

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

Outcome Time Frame:

pCR will be assesed after 24 weeks of treatment

Safety Issue:

No

Principal Investigator

Claudia Arce, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto Nacional Canerologia

Authority:

Mexico: Federal Commission for Protection Against Health Risks

Study ID:

MET-INCAN-1

NCT ID:

NCT01566799

Start Date:

April 2012

Completion Date:

April 2014

Related Keywords:

  • Locally Advanced Malignant Neoplasm
  • Locally advanced breast cancer
  • Neoadjuvant chemotherapy
  • Metformin
  • Pathologic Complete Response
  • Breast Neoplasms
  • Neoplasms

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