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Randomized Trial of Neo-adjuvant Chemotherapy With or Without Metformin for HER2 Positive Operable Breast Cancer

NCT03238495 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-12-07

No results posted yet for this study

Summary

The primary objective of this study is to determine the efficacy of metformin as a repurposed agent in human epidermal growth factor receptor 2 (HER2) positive breast cancer when added to standard neo-adjuvant chemotherapy.

Conditions

Interventions

DRUG

Taxotere, Carboplatin, Herceptin + Pertuzumab

TCH+P chemotherapy every 3 weeks for 6 cycles: Taxotere 75mg/m2, Carboplatin AUC 6, Herceptin 6mg/kg (first cycle loading dose of 8mg/kg), Pertuzumab 420mg (first cycle loading does of 840mg)

DRUG

Metformin

TCH+P chemotherapy every 3 weeks for 6 cycles. Metformin 850 mg daily during the first cycle, then 850 mg twice daily for the remaining 5 cycles.

Sponsors & Collaborators

  • Qamar Khan

    lead OTHER

Principal Investigators

  • Qamar Khan, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-15
Primary Completion
2022-06-01
Completion
2023-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03238495 on ClinicalTrials.gov