Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- 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.
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||February 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437853
|Instituto Nacional de Cancerologia de Mexico|
|Mexico D.F., Mexico, D.F., Mexico, 14080|
|Principal Investigator:||Flavia Morales-Vasquez||Instituto Nacional de Cancerologia Mexico|
|Study Director:||Alejandro Mohar||Instituto Nacional de Cancerologia Mexico|
|Study Chair:||Alfonso Dueñas Gonzalez||Instituto Nacional de Cancerología|