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A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive (HR+) Human Epidermal Receptor 2 Negative (HER2-) Breast Cancer.

NCT03906669 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-11-22

No results posted yet for this study

Summary

A phase II randomised, open label study of pre-operative endocrine therapy with \& without prometrium in postmenopausal women with early stage breast hormone receptor positive (HR+) human epidermal receptor 2 negative (HER2-) breast cancer.

Conditions

Interventions

DRUG

Letrozole

PO daily for 14 days

DRUG

Letrozole and Prometrium

PO daily for 14 days

DRUG

Tamoxifen and Prometrium

PO daily for 14 days

Sponsors & Collaborators

  • St Vincent's Hospital

    lead OTHER

Principal Investigators

  • Elgene Lim, MBBS FRACP PhD · Garvan Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Australia

Study Locations

More Related Trials

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 NCT03906669 on ClinicalTrials.gov