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Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437853
First Posted: February 21, 2007
Last Update Posted: February 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by:
Instituto Nacional de Cancerologia de Mexico
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years and older   (Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00437853     History of Changes
Obsolete Identifiers: NCT00262535
Other Study ID Numbers: 1033MX/0001
First Submitted: February 20, 2007
First Posted: February 21, 2007
Last Update Posted: February 21, 2007
Last Verified: February 2007

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs