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Trial record 1 of 1 for:    NCT00128843
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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 : February 18, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Tracking Information
First Submitted Date  ICMJE August 9, 2005
First Posted Date  ICMJE August 10, 2005
Last Update Posted Date February 18, 2019
Actual Study Start Date  ICMJE August 2001
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
Overall Response Rate (ORR) in both arms [ Time Frame: up to 12 months ]
Complete response plus partial response
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2005)
Overall response rate.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • 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
  • 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
  • Clinical benefit (1st line) [ Time Frame: up to 6 months ]
    Completed response (CR) plus Partial Response (PR) plus Stable Diasease (SD) lasting ≥6 months
  • Clinical benefit after crossover (2nd line) [ Time Frame: up to 6 months ]
    Completed response (CR) plus Partial Response (PR) plus Stable Diasease
  • Survival [ Time Frame: up to 36 months ]
    Time from randomization of last patient included until death whatever cause.
  • Survival after crossover [ Time Frame: up to 24 months ]
    Time from crossover until death whatever cause.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2005)
  • Time to progression.Time to progression after crossover.
  • Clinical benefit.Clinical benefit after crossover.
  • Survival. Survival after crossover.
  • Toxicity. Toxicity after crossover.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exemestane Versus Anastrozole as First Line Hormone Therapy in Postmenopausal Metastatic Breast Cancer Patients
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Exemestane
    25mg/day until progression disease
    Other Name: Aromasil
  • Drug: Anastrozole
    1mg/day until progression disease
    Other Name: Arimidex
Study Arms  ICMJE
  • 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
    Intervention: Drug: Anastrozole
  • 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
    Intervention: Drug: Exemestane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2018)
103
Original Enrollment  ICMJE
 (submitted: August 9, 2005)
100
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00128843
Other Study ID Numbers  ICMJE GEICAM 2001-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spanish Breast Cancer Research Group
Study Sponsor  ICMJE Spanish Breast Cancer Research Group
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Study Director Instituto Valenciano de Oncología
PRS Account Spanish Breast Cancer Research Group
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP