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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00128843
First received: August 9, 2005
Last updated: September 23, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Exemestane
Drug: Anastrozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Randomized, Multicenter, Crossover Clinical Trial for Administration of Exemestane vs. Anastrozole as First Line Treatment for Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Spanish Breast Cancer Research Group:

Primary Outcome Measures:
  • Overall response rate

Secondary Outcome Measures:
  • Time to progression
  • Time to progression after crossover
  • Clinical benefit
  • Clinical benefit after crossover
  • Survival
  • Survival after crossover
  • Toxicity
  • Toxicity after crossover

Estimated Enrollment: 100
Study Start Date: August 2001
Estimated Study Completion Date: July 2005
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 (exemestane), and p0 is the minimum expected activity. In this study, p1 is 25% (25% of RR) and p0 is 10% (10% of RR). With an alpha error of 0.05 and a beta error of 0.1, Simon test establishes a first step of 21 patients per treatment arm. If at least 2 objective responses are observed in exemestane arm, recruitment will continue until 100 patients have been recruited. After this second recruitment phase, at least 7 objective responses must be observed to confirm the expected exemestane level of activity.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128843

Locations
Spain
Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Pfizer
Investigators
Study Chair: Antonio Llombart, MD., PhD. Spanish Breast Cancer Research Group
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00128843     History of Changes
Other Study ID Numbers: GEICAM 2001-03
Study First Received: August 9, 2005
Last Updated: September 23, 2008
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Breast Cancer Research Group:
Metastatic breast cancer
First line of hormone treatment
Postmenopausal women
Positive hormone receptor tumours

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Exemestane
Anastrozole
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on April 17, 2014