Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437853
• Other study ID #: 1033MX/0001
• Status: Completed
• Phase: N/A
• First received: February 20, 2007
• Last updated: February 20, 2007
• Start date: June 2003
• Est. completion date: February 2007

Study information

• Verified date: February 2007
• Source: Instituto Nacional de Cancerologia de Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics CommitteeMexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00262535

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 66 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Anastrozole

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cancerologia de Mexico	Mexico D.F.	Mexico, D.F.

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia de Mexico	AstraZeneca

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint was to compare overall objective response (OR) determined by clinical (palpation) and ultrasound.
Secondary	Secondary endpoint was the number of patients who qualified for BCS plus radiotherapy.