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

NCT00128843 | Completed Phase 2

• 1 other identifier: GEICAM 2001-03
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 13

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.

Conditions

Breast Cancer

Keywords

Metastatic breast cancer; First line of hormone treatment; Postmenopausal women; Positive hormone receptor tumours

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) in both arms

  Complete response plus partial response

  up to 12 months

Secondary Outcomes (8)

• Time to progression

  From date of randomization until the date of new documented progression, assessed up to 24 months

• Time to progression after crossover

  From date of crossover until the date of new documented progression, assessed up to 5 months

• Clinical benefit (1st line)

  up to 6 months

• Clinical benefit after crossover (2nd line)

  up to 6 months

• Survival

  up to 36 months

Study Arms (2)

Exemestane

EXPERIMENTAL

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

Drug: Anastrozole

Anastrozole

ACTIVE COMPARATOR

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

Drug: Exemestane

Interventions

Exemestane DRUG

25mg/day until progression disease

Also known as: Aromasil

Anastrozole

Anastrozole DRUG

1mg/day until progression disease

Also known as: Arimidex

Exemestane

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Pfizer: collaborator

Study Sites (13)

Germans Trias i Pujol

Badalona, Barcelona, Spain

Location

Clínico Universitario A Coruña (CHUAC)

A Coruña, Galicia, Spain

Location

Onkologikoa

Donostia / San Sebastian, Guipúzcoa, 20012, Spain

Location

Hospital Donostia

Donostia / San Sebastian, Guipúzcoa, 20014, Spain

Location

H Comarcal de Barbastro

Barbastro, Huesca, Spain

Location

H Puerto de Sagunto

Sagunto, Valencia, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, 28040, Spain

Location

Puerta de Hierro

Madrid, Spain

Location

Ruber Internacional

Madrid, Spain

Location

H Sant Camil

Tarragona, Spain

Location

Instituto Valenciano de Oncología (IVO)

Valencia, 46009, Spain

Location

Clínico Lozano Blesa

Zaragoza, Spain

Location

H Universitario Miguel Servet

Zaragoza, Spain

Location

Related Publications (1)

• 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.

  PMID: 21717449 RESULT

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Study Director

  Instituto Valenciano de Oncología

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2005
• First Posted: August 10, 2005
• Study Start: August 1, 2001
• Primary Completion: July 1, 2005
• Study Completion: October 1, 2014
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

ES (13)