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

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ClinicalTrials.gov Identifier: NCT00128843
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Exemestane Drug: Anastrozole Phase 2

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  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Actual Study Start Date : August 2001
Actual Primary Completion Date : July 2005
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Aromasil



Primary Outcome Measures :
  1. Overall Response Rate (ORR) in both arms [ Time Frame: up to 12 months ]
    Complete response plus partial response


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Clinical benefit (1st line) [ Time Frame: up to 6 months ]
    Completed response (CR) plus Partial Response (PR) plus Stable Diasease (SD) lasting ≥6 months

  4. Clinical benefit after crossover (2nd line) [ Time Frame: up to 6 months ]
    Completed response (CR) plus Partial Response (PR) plus Stable Diasease

  5. Survival [ Time Frame: up to 36 months ]
    Time from randomization of last patient included until death whatever cause.

  6. Survival after crossover [ Time Frame: up to 24 months ]
    Time from crossover until death whatever cause.

  7. Toxicity [ 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.

  8. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128843


Locations
Spain
Germans Trias i Pujol
Badalona, Barcelona, Spain
Clínico Universitario A Coruña (CHUAC)
A Coruña, Galicia, Spain
Onkologikoa
Donostia-San Sebastián, Guipúzcoa, Spain, 20012
Hospital Donostia
Donostia-San Sebastián, Guipúzcoa, Spain, 20014
H Comarcal de Barbastro
Barbastro, Huesca, Spain
H Puerto de Sagunto
Sagunto, Valencia, Spain
Hospital Clínico Universitario San Carlos
Madrid, Spain, 28040
Puerta de Hierro
Madrid, Spain
Ruber Internacional
Madrid, Spain
H Sant Camil
Tarragona, Spain
Instituto Valenciano de Oncología (IVO)
Valencia, Spain, 46009
Clínico Lozano Blesa
Zaragoza, Spain
H Universitario Miguel Servet
Zaragoza, Spain
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Pfizer
Investigators
Study Director: Study Director Instituto Valenciano de Oncología

Additional Information:
Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00128843     History of Changes
Other Study ID Numbers: GEICAM 2001-03
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

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
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal