Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer

NCT00437853 | Completed

• 1 other identifier: 1033MX/0001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The primary endpoint was to compare overall objective response (OR) determined by clinical (palpation) and ultrasound.

Secondary Outcomes (1)

• Secondary endpoint was the number of patients who qualified for BCS plus radiotherapy.

Interventions

Anastrozole DRUG

Eligibility Criteria

• Age: 66 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Postmenopausal women who had primary breast cancer, histological confirmed, through a core needle biopsy, and who{s tumors positive for estrogens receptor ER/PR.
• Clinical stage IIB or IIIA Tumor assessable by clinical exam, mammogram or and ultrasound Adequate functional bone marrow Documented evidence adequate renal function and liver function Life expectancy for six months Written inform consent

You may not qualify if:

• Prior treatment with letrozole or tamoxifen uncontrol disorders patients with instable angina or uncontrol cardiac disease patient with bilateral breast tumors patients elegies for conservative breast surgery Inflammatory breast cancer o distant metastases Other concurrent malignancies, except carcinoma with in situ cono biopsy of uterine cervix or adequate treat skin cancer no melanoma concomitant cancer treatment such as chemotherapy, immunotherapy biological modulators, endocrinotherapy, biphosphonates therapy and radiotherapy.
• Concomitant treatment with steroids Others research drug whiting the last 30 days and concomitant use of research drugs History non compliance with medications schedules and patients consider potential unreliable.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead
• AstraZeneca: collaborator

Study Sites (1)

Instituto Nacional de Cancerologia de Mexico

Mexico City, Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Flavia Morales-Vasquez

  Instituto Nacional de Cancerologia Mexico

  PRINCIPAL INVESTIGATOR

• Alejandro Mohar

  Instituto Nacional de Cancerologia Mexico

  STUDY DIRECTOR

• Alfonso Dueñas Gonzalez

  Instituto Nacional de Cancerologia de Mexico

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 21, 2007
• Study Start: June 1, 2003
• Study Completion: February 1, 2007
• Last Updated: February 21, 2007

Record last verified: 2007-02

Locations

ME (1)