Exemestane Versus Anastrozole as First Line Hormone Therapy in Postmenopausal Metastatic Breast Cancer Patients

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

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 postmenopausal patients, with metastatic, positive hormone receptor breast cancer will be enrolled in this trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Breast Cancer Research Group
• Collaborator: Pfizer
• Treatments: Anastrozole; Exemestane; Hormones

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.