Breast CancerNCT00437853
Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer
A study testing Anastrozole in people with Breast Cancer, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 66 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anastrozole
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2003to Feb 2007
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Cancerologia de Mexico
Mexico City, Mexico City, 14080
About this study
EFFICACY OF NEOADJUVANT ENDOCRINE THERAPY WITH ANASTROZOLE IN POMENOPAUSAL WOMEN WITH ER-POSITIVE BREAST CANCER.
Flavia Morales-Vásquez, Horacio Noé López Basave.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- Anastrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was to compare overall objective response (OR) determined by clinical (palpation) and ultrasound.
Secondary outcomes (1)
Secondary endpoint was the number of patients who qualified for BCS plus radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startJun 2003
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Flavia Morales-Vasquez, Principal investigator, Instituto Nacional de Cancerologia MexicoAlejandro Mohar, Study director, Instituto Nacional de Cancerologia MexicoAlfonso Dueñas Gonzalez, Study chair, Instituto Nacional de Cancerologia de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437853
- Sponsor's protocol ID
- 1033MX/0001
- Status last verified
- Feb 2007
- First submitted
- 20 Feb 2007
- Last updated
- 21 Feb 2007
- Results posted
- No