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

NCT ID: NCT00128843

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2014-10-31

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

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exemestane

25mg/day per VO until progression disease, after this progression the patient could receive the another drug (comparator arm) ie Anastrozole by investigator decision

Group Type: EXPERIMENTAL

Anastrozole

Intervention Type: DRUG

1mg/day until progression disease

Anastrozole

1mg/day per VO until progression disease, after this progression the patient could receive the another drug (experimental arm) ie Exemestane by investigator decision

Group Type: ACTIVE_COMPARATOR

Exemestane

Intervention Type: DRUG

25mg/day until progression disease

Interventions

Exemestane

25mg/day until progression disease

Intervention Type: DRUG

Anastrozole

1mg/day until progression disease

Intervention Type: DRUG

Other Intervention Names

Aromasil; Arimidex

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Spanish Breast Cancer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Instituto Valenciano de Oncología

Locations

Germans Trias i Pujol

Badalona, Barcelona, Spain

Clínico Universitario A Coruña (CHUAC)

A Coruña, Galicia, Spain

Onkologikoa

Donostia / San Sebastian, Guipúzcoa, Spain

Hospital Donostia

Donostia / San Sebastian, Guipúzcoa, Spain

H Comarcal de Barbastro

Barbastro, Huesca, Spain

H Puerto de Sagunto

Sagunto, Valencia, Spain

Hospital Clínico Universitario San Carlos

Madrid, , Spain

Puerta de Hierro

Madrid, , Spain

Ruber Internacional

Madrid, , Spain

H Sant Camil

Tarragona, , Spain

Instituto Valenciano de Oncología (IVO)

Valencia, , Spain

Clínico Lozano Blesa

Zaragoza, , Spain

H Universitario Miguel Servet

Zaragoza, , Spain

Countries

Spain

References

Llombart-Cussac A, Ruiz A, Anton A, Barnadas A, Antolin S, Ales-Martinez JE, Alvarez I, Andres R, Garcia Saenz JA, Lao J, Carrasco E, Camara C, Casas I, Martin M. Exemestane versus anastrozole as front-line endocrine therapy in postmenopausal patients with hormone receptor-positive, advanced breast cancer: final results from the Spanish Breast Cancer Group 2001-03 phase 2 randomized trial. Cancer. 2012 Jan 1;118(1):241-7. doi: 10.1002/cncr.26299. Epub 2011 Jun 29.

Reference Type: RESULT

PMID: 21717449 (View on PubMed)

Related Links

http://www.geicam.org

Click here for more information about this study: GEICAM 2001-03

Other Identifiers

GEICAM 2001-03

Identifier Type: -

Identifier Source: org_study_id