Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer

NCT00437853 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2007-02-21

No results posted yet for this study

Summary

EFFICACY OF NEOADJUVANT ENDOCRINE THERAPY WITH ANASTROZOLE IN POMENOPAUSAL WOMEN WITH ER-POSITIVE BREAST CANCER.

Flavia Morales-Vásquez, Horacio Noé López Basave.

Background: Neoadjuvant Hormonal Therapy (HT) is being used increasingly to downstage locally advanced and large operable breast cancer. Following this treatment, inoperable breast cancer often becomes fully respectable and tumors requiring mastectomy may be successfully removed by breast-conserving surgery (BCS).

Methods: Recruit postmenopausal women with ER(+) and/or PgR (+) breast cancer (BC) T2,N1-2 to T3,N0-1 were assigned to HT with anastrozole 1 mgr daily for 4 months.

The primary endpoint was to compare overall objective response (OR) determined by clinical (palpation) and ultrasound. Secondary endpoint was the number of patients who qualified for BCS plus radiotherapy.

Conditions

Interventions

DRUG

Anastrozole

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY
  • Instituto Nacional de Cancerologia de Mexico

    lead OTHER

Principal Investigators

  • Flavia Morales-Vasquez · Instituto Nacional de Cancerologia Mexico

  • Alejandro Mohar · Instituto Nacional de Cancerologia Mexico

  • Alfonso Dueñas Gonzalez · Instituto Nacional de Cancerologia de Mexico

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
66 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Completion
2007-02-28

Countries

  • Mexico

Study Locations

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Entities

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 NCT00437853 on ClinicalTrials.gov