Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer

June 29, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the efficacy of exemestane vs tamoxifen, in terms of progression-free survival, in postmenopausal women with locally recurrent or metastatic breast cancer.
  • Determine the safety profile of exemestane in these patients.
  • Compare the overall survival of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. (Phase II of this study closed as of 6/14/00). Patients are stratified by participating center, prior adjuvant tamoxifen (yes vs no), prior chemotherapy for metastatic disease (yes vs no), and dominant site of metastasis (visceral with or without others vs bone only vs bone and soft tissue vs soft tissue only).

Patients are randomized to receive either oral exemestane or oral tamoxifen daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 18 months and then at least every 6 months thereafter.

PROJECTED ACCRUAL: A total of 342 patients will be accrued for this study within 4.7 years.

Study Type

Interventional

Enrollment (Anticipated)

342

Phase

  • Phase 3

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

  • Australia
      • Bankstown, Australia, NSW 2200
        • Bankstown - Lidcombe Hospital
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
  • Belgium
      • Antwerp, Belgium, 2020
        • Algemeen Ziekenhuis Middelheim
      • Brussels (Bruxelles), Belgium, 1000
        • Institut Jules Bordet
      • Brussels (Bruxelles), Belgium, B-1050
        • Centre Hospitalier Etterbeek Ixelles
      • Haine Saint Paul, Belgium, 7100
        • Hopital de Jolimont
      • La Louviere, Belgium, 7100
        • Centre Hospitalier Universitaire de Tivoli
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
      • Namur, Belgium, 5000
        • Clinique Sainte Elisabeth
      • Wilrijk, Belgium, 2610
        • Algemeen Ziekenhuis Sint-Augustinus
  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Dijon, France, 21079
        • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Rennes, France, 35064
        • Centre Eugene Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint Cloud, France, 92211
        • Centre René Huguenin
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University of Malaysia Medical Center
  • Netherlands
      • 's-Gravenhage (Den Haag, The Hague), Netherlands, 2545 CH
        • Leyenburg Ziekenhuis
      • Amersfont, Netherlands, 3016 CP
        • Ziekenhuis Eemland de Lichtenberg
      • Amsterdam, Netherlands, 1091 HA
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoekhuis
      • Eindhoven, Netherlands, 5602 ZA
        • Catharina Ziekenhuis
      • Leiden, Netherlands, 2300 CA
        • Leiden University Medical Center
      • Leidschendam, Netherlands, 2262 BA
        • Medisch Centrum Haaglanden Locatle Antoniushove
      • Maastricht, Netherlands, 6202 AZ
        • Academisch Ziekenhuis Maastricht
      • Nijmegen, Netherlands, NL-6500 HB
        • University Medical Center Nijmegen
      • Purmerend, Netherlands, 1440 AG
        • Waterlandziekenhuis
      • Roermond, Netherlands, 6043 CV
        • Saint Laurentius Ziekenhuis
      • Rotterdam, Netherlands, 3075 EA
        • Rotterdam Cancer Institute
      • Sittard, Netherlands, 6131 BK
        • Maasland Hospital
      • Tilburg, Netherlands, 5022 GC
        • St. Elisabeth Ziekenhuis
      • Utrecht, Netherlands, 3508 TG
        • Diakonessenhuis Utrecht
      • Veldhoven, Netherlands, 5500 MB DB
        • Sint Joseph Ziekenhuis
  • Philippines
      • Cebu City, Philippines, 6000
        • Chong Hua Medical Arts Center
  • Poland
      • Gdansk, Poland, 80-211
        • Medical University of Gdansk
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Russian Academy of Medical Sciences Cancer Research Center
      • Saint Petersburg, Russian Federation, 197758
        • Petrov Research Institute of Oncology
  • Slovenia
      • Ljubljana, Slovenia, Sl-1000
        • Institute of Oncology, Ljubljana
  • Taiwan
      • Taipei, Taiwan, NEIHU- 114
        • Tri-Service General Hospital
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
  • United Kingdom
    • England
      • London, England, United Kingdom, SE1 9RT
        • Guy's and St. Thomas' Hospitals Trust
      • Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW
        • South Tees Hospitals NHS Trust
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Weston Park Hospital
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Western General Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven adenocarcinoma of the breast that is metastatic and progressive or locally recurrent and inoperable

  • At least one bidimensionally measurable or evaluable lesion

    • Lytic bone lesions on x-ray/CT scan, surrounded by calcified bone, and at least 1 cm
    • Bidimensionally measurable extraosseous disease required for patients on bisphosphonates

    • The following are not considered evaluable:

      • Previously irradiated lesions
      • Lymphangitic spread
      • Ascites
      • Blastic bone lesions
      • Pleural effusions
  • No rapidly progressive disease for which hormonal therapy is not indicated
  • No massive visceral disease (i.e., more than one third of any organ)
  • No brain metastases

  • Hormone receptor status:

    • Estrogen receptor positive or progesterone receptor positive, defined by 1 of the following:

      • At least 10 femtomoles H3-estrogen or at least 20 femtomoles
      • H3 progesterone binding per mg of cytosol protein by DCC or sucrose density method
      • At least 0.10 femtomoles H3-estrogen or at least 0.20 femtomoles
      • H3-progesterone binding per mg of DNA by IF/EIA technique
      • Positive immunohistochemistry noted on pathology report

    • Unknown receptor status eligible provided:

      • Disease-free interval of at least 2 years since adjuvant therapy or initial surgery (if no adjuvant therapy), including most recently treated tumor in bilateral breast cancer if status unknown in one primary tumor

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Postmenopausal by 1 of the following:

    • Natural menopause and more than 1 year since last menstrual period (LMP)
    • Radiation-induced oophorectomy and more than 1 year since LMP

    • Chemotherapy induced menopause if:

      • At least 1 year since LMP (+ 1 year post-tamoxifen)
      • Serum FSH and LH and plasma estradiol levels in postmenopausal range
      • LHRH-induced amenorrhea

    • Surgical castration

      • Patients under age 56 with prior hysterectomy and 1 or both ovaries intact or tamoxifen-induced amenorrhea with at least 12 months since prior tamoxifen must have postmenopausal serum FSH and LH and plasma estradiol concentrations

Performance status:

  • ECOG (WHO) 0-2

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT/SGPT less than 2.5 times ULN (less than 5 times ULN with liver metastases)

Renal:

  • Creatinine less than 1.5 times ULN

Cardiovascular:

  • No deep venous thrombosis

Other:

  • No mental incapacitation
  • No severe concurrent disease
  • No prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since chemotherapy for metastatic disease and recovered
  • No more than 1 prior chemotherapy regimen for metastatic disease
  • Prior adjuvant chemotherapy allowed if disease free for at least 6 months
  • No concurrent chemotherapy

Endocrine therapy:

  • No prior hormonal therapy for advanced disease (e.g., tamoxifen or LHRH agonists)
  • Prior adjuvant tamoxifen allowed if disease free for at least 6 months
  • No other concurrent hormonal therapy, including steroids

Radiotherapy:

  • Recovered from toxic effects of prior radiotherapy
  • Concurrent palliative radiotherapy, including whole brain irradiation, allowed

Surgery:

  • See Disease Characteristics
  • No prior ovariectomy for advanced disease

Other:

  • No other concurrent investigational drugs
  • Concurrent bisphosphonates allowed if short term (7 days) for hypercalcemia due to suspect tumor flare or if on prior bisphosphonates with bidimensionally measurable extraosseous lesion

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

Collaborators and Investigators

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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

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

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

May 1, 1996

Primary Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 10, 2003

First Posted (Estimate)

April 11, 2003

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-10951
  • PHARMACIA-EORTC-10951

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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