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Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer

NCT00629616 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2021-06-09

No results posted yet for this study

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy before surgery may be an effective treatment for breast cancer. It is not yet known whether anastrozole is more effective than fulvestrant when given before surgery in treating women with breast cancer.

PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal women with stage II or stage III breast cancer that can be removed by surgery.

Conditions

Interventions

DRUG

anastrozole

1 mg/day for either 4 months or 6 months depending on the clinical evaluation

DRUG

fulvestrant

500mg at day 1, day 15 and day 29 500mg every 28 days for either 4 months or 6 months depending on the clinical evaluation

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Florence Lerebours, MD · Institut Curie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2015-06-30
Completion
2018-04-30

Countries

  • France

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 NCT00629616 on ClinicalTrials.gov