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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128843
• Other study ID #: GEICAM 2001-03
• Status: Completed
• Phase: Phase 2
• Start date: August 2001
• Est. completion date: October 2014

Study information

• Verified date: March 2023
• Source: Spanish Breast Cancer Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 2014
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Exemestane
25mg/day until progression disease
• Anastrozole
1mg/day until progression disease

Locations

Country	Name	City	State
Spain	Clínico Universitario A Coruña (CHUAC)	A Coruña	Galicia
Spain	Germans Trias i Pujol	Badalona	Barcelona
Spain	H Comarcal de Barbastro	Barbastro	Huesca
Spain	Hospital Donostia	Donostia-San Sebastián	Guipúzcoa
Spain	Onkologikoa	Donostia-San Sebastián	Guipúzcoa
Spain	Hospital Clínico Universitario San Carlos	Madrid
Spain	Puerta de Hierro	Madrid
Spain	Ruber Internacional	Madrid
Spain	H Puerto de Sagunto	Sagunto	Valencia
Spain	H Sant Camil	Tarragona
Spain	Instituto Valenciano de Oncología (IVO)	Valencia
Spain	Clínico Lozano Blesa	Zaragoza
Spain	H Universitario Miguel Servet	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Breast Cancer Research Group	Pfizer

Country where clinical trial is conducted

Spain, 

References & 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 wit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) in both arms	Complete response plus partial response	up to 12 months
Secondary	Time to progression	Time from last patient included to progression disease	From date of randomization until the date of new documented progression, assessed up to 24 months
Secondary	Time to progression after crossover	Time from crossover (2nd line) to progression disease	From date of crossover until the date of new documented progression, assessed up to 5 months
Secondary	Clinical benefit (1st line)	Completed response (CR) plus Partial Response (PR) plus Stable Diasease (SD) lasting =6 months	up to 6 months
Secondary	Clinical benefit after crossover (2nd line)	Completed response (CR) plus Partial Response (PR) plus Stable Diasease	up to 6 months
Secondary	Survival	Time from randomization of last patient included until death whatever cause.	up to 36 months
Secondary	Survival after crossover	Time from crossover until death whatever cause.	up to 24 months
Secondary	The Number of Participants Who Experienced Adverse Events (AE)	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)
Secondary	Toxicity after crossover	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)

External Links

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