Status:
COMPLETED
Exemestane Versus Anastrozole as First Line Hormone Therapy in Postmenopausal Metastatic Breast Cancer Patients
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Pfizer
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-90 years
Phase:
PHASE2
Brief Summary
This is a pivotal phase II, multicenter, open-label trial, designed to compare the efficacy of exemestane versus anastrozole as a first line treatment for advanced breast cancer. One hundred postmenop...
Detailed Description
The primary study endpoint is objective response rate. The study has been designed following Simon's test, with a p1-p0=0.15. p1 is the optimum level of activity of the experimental treatment (exemest...
Eligibility Criteria
Inclusion
- Pathological diagnoses of breast cancer.
- Postmenopausal women, defined as:
- Bilateral surgical oophorectomy or amenorrhoea \>= 5 years;
- Age \>= 56 years old and amenorrhoea \>= 1 year;
- Chemotherapy induced amenorrhoea \>= 2 years;
- Radiotherapy induced amenorrhoea at least 3 months before:
- Age \< 56 and \< 5 years of amenorrhoea: follicle-stimulating hormone (FSH) levels to confirm postmenopausal status.
- Metastatic breast cancer (stage IV) or non-operable locally advanced breast cancer (stage IIIB).
- Positive estrogen and/or progesterone receptors as \>10% cells or \>10fmol/mg.
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Patients who have received adjuvant tamoxifen are eligible, if progression has been established at least 24 months since treatment start.
- Neoadjuvant chemotherapy is allowed if progression has been established at least 12 months after end of treatment.
- Patients may have received a first line of chemotherapy for advanced disease, but treatment must have ended at least 4 weeks before enrolment, and all acute toxicities must be resolved. Previous treatment with Herceptin is allowed.
- Normal haematological, hepatic and renal functions.
- Performance status ECOG of 0, 1, 2.
- Life expectancy superior to 3 months.
- Written informed consent.
Exclusion
- Previous hormone treatment for metastatic disease.
- Previous treatment with aromatase inhibitors.
- Inflammatory breast cancer, or aggressive metastatic disease, or visceral lesions, or metastasis in the central nervous system (CNS).
- Non-measurable disease.
- Second malignancy except for basal skin carcinoma or cervical in situ carcinoma adequately treated. If other malignancies, patient must have a disease-free period superior to 5 years.
- Treatment with any investigational product in the 4 previous weeks.
- Patients with negative estrogen and progesterone receptor tumours.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00128843
Start Date
August 1 2001
End Date
October 1 2014
Last Update
March 6 2023
Active Locations (13)
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1
Germans Trias i Pujol
Badalona, Barcelona, Spain
2
Clínico Universitario A Coruña (CHUAC)
A Coruña, Galicia, Spain
3
Onkologikoa
Donostia / San Sebastian, Guipúzcoa, Spain, 20012
4
Hospital Donostia
Donostia / San Sebastian, Guipúzcoa, Spain, 20014