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

March 3, 2023 updated by: Spanish Breast Cancer Research Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clínico Universitario San Carlos
      • Madrid, Spain
        • Puerta de Hierro
      • Madrid, Spain
        • Ruber Internacional
      • Tarragona, Spain
        • H Sant Camil
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología (IVO)
      • Zaragoza, Spain
        • Clínico Lozano Blesa
      • Zaragoza, Spain
        • H Universitario Miguel Servet
    • Barcelona
      • Badalona, Barcelona, Spain
        • Germans Trias I Pujol
    • Galicia
      • A Coruña, Galicia, Spain
        • Clínico Universitario A Coruña (CHUAC)
    • Guipúzcoa
      • Donostia-San Sebastián, Guipúzcoa, Spain, 20012
        • Onkologikoa
      • Donostia-San Sebastián, Guipúzcoa, Spain, 20014
        • Hospital Donostia
    • Huesca
      • Barbastro, Huesca, Spain
        • H Comarcal de Barbastro
    • Valencia
      • Sagunto, Valencia, Spain
        • H Puerto de Sagunto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Anastrozole
1mg/day until progression disease
Other Names:
  • Arimidex
Active Comparator: 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
Drug: Exemestane
25mg/day until progression disease
Other Names:
  • Aromasil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) in both arms
Time Frame: up to 12 months
Complete response plus partial response
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: From date of randomization until the date of new documented progression, assessed up to 24 months
Time from last patient included to progression disease
From date of randomization until the date of new documented progression, assessed up to 24 months
Time to progression after crossover
Time Frame: From date of crossover until the date of new documented progression, assessed up to 5 months
Time from crossover (2nd line) to progression disease
From date of crossover until the date of new documented progression, assessed up to 5 months
Clinical benefit (1st line)
Time Frame: up to 6 months
Completed response (CR) plus Partial Response (PR) plus Stable Diasease (SD) lasting ≥6 months
up to 6 months
Clinical benefit after crossover (2nd line)
Time Frame: up to 6 months
Completed response (CR) plus Partial Response (PR) plus Stable Diasease
up to 6 months
Survival
Time Frame: up to 36 months
Time from randomization of last patient included until death whatever cause.
up to 36 months
Survival after crossover
Time Frame: up to 24 months
Time from crossover until death whatever cause.
up to 24 months
The Number of Participants Who Experienced Adverse Events (AE)
Time Frame: Until 30 days after the end of last patient study treatment (1st line)
Patients who will receive at least one dose of Exemestane or Anastrozole will be evaluated for safety and toxicity. Safety will be assess by recording all clinical adverse events at each patient.
Until 30 days after the end of last patient study treatment (1st line)
Toxicity after crossover
Time Frame: Until 30 days after the end of last patient study treatment (crossover: 2nd line)
Patients who will receive at least one dose of Exemestane or Anastrozole will be evaluated for safety and toxicity. Safety will be assess by recording all clinical adverse events at each patient.
Until 30 days after the end of last patient study treatment (crossover: 2nd line)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Breast Cancer Research Group

Collaborators

Pfizer

Investigators

  • Study Director: Study Director, Instituto Valenciano de Oncologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2001

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 9, 2005

First Submitted That Met QC Criteria

August 9, 2005

First Posted (Estimate)

August 10, 2005

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEICAM 2001-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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