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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 11, 2003
Last Update Posted: July 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
November 1, 1999
April 11, 2003
July 2, 2012
May 1996
December 2002   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00002777 on ClinicalTrials.gov Archive Site
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Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer

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.


  • 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.

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Breast Cancer
  • Drug: exemestane
  • Drug: tamoxifen citrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Not Provided
December 2002   (Final data collection date for primary outcome measure)


  • 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



  • 18 and over


  • 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


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


  • 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)


  • Creatinine less than 1.5 times ULN


  • No deep venous thrombosis


  • 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


Biologic therapy:

  • No concurrent immunotherapy


  • 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


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


  • See Disease Characteristics
  • No prior ovariectomy for advanced disease


  • 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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   France,   Malaysia,   Netherlands,   Philippines,   Poland,   Russian Federation,   Slovenia,   Taiwan,   Thailand,   United Kingdom
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European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Robert Paridaens, MD, PhD University Hospital, Gasthuisberg
European Organisation for Research and Treatment of Cancer - EORTC
June 2012

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