Clinical trial NCT00437853: Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Instituto Nacional de Cancerologia de Mexico
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2007-02-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The primary endpoint was to compare overall objective response (OR) determined by clinical (palpation) and ultrasound.
Secondary outcomes:
measure: Secondary endpoint was the number of patients who qualified for BCS plus radiotherapy.
Other outcomes:
Locations:
city: Mexico D.F.
country: Mexico
facility: Instituto Nacional de Cancerologia de Mexico
state: Mexico, D.F.
Study officials:
affiliation: Instituto Nacional de Cancerologia Mexico
name: Flavia Morales-Vasquez
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Cancerologia Mexico
name: Alejandro Mohar
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Cancerologia de Mexico
name: Alfonso Dueñas Gonzalez
role: STUDY_CHAIR
References: