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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

February 20, 2007
February 20, 2007
June 2003
Not Provided
The primary endpoint was to compare overall objective response (OR) determined by clinical (palpation) and ultrasound.
Same as current
No Changes Posted
Secondary endpoint was the number of patients who qualified for BCS plus radiotherapy.
Same as current
Not Provided
Not Provided
 
Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: Anastrozole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2007
Not Provided

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.

Female
66 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00437853
1033MX/0001
Not Provided
Not Provided
Instituto Nacional de Cancerologia de Mexico
AstraZeneca
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
Instituto Nacional de Cancerologia de Mexico
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP