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Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier:
NCT00437853
First received: February 20, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Cancer
 Drug: Anastrozole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Anastrozole
U.S. FDA Resources

Further study details as provided by Instituto Nacional de Cancerologia de Mexico:

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

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

Estimated Enrollment: 30
Study Start Date: June 2003
Estimated Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   66 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437853

Locations
Mexico
Instituto Nacional de Cancerologia de Mexico
Mexico D.F., Mexico, D.F., Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
AstraZeneca
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00437853     History of Changes
Obsolete Identifiers: NCT00262535
Other Study ID Numbers: 1033MX/0001
Study First Received: February 20, 2007
Last Updated: February 20, 2007
Health Authority: Mexico: Ethics Committee
Mexico: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013