Quality of Life in Postmenopausal Women Who Are Receiving Either Exemestane or Anastrozole With or Without Celecoxib for Stage I, Stage II, or Stage IIIA Primary Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: September 7, 2004
Last updated: August 19, 2009
Last verified: January 2006

RATIONALE: Quality-of-life assessment in postmenopausal women who are receiving hormone therapy for breast cancer may help to determine the effects of treatment on these patients and may improve the quality of life for future breast cancer patients.

PURPOSE: This clinical trial is studying quality of life of postmenopausal women who are receiving either exemestane or anastrozole with or without celecoxib for stage I, stage II, or stage IIIA primary breast cancer.

Condition Intervention
Breast Cancer
Procedure: quality-of-life assessment

Study Type: Observational
Official Title: Quality Of Life Companion Study For JMA27 (NCIC-MA.27): A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2004
Detailed Description:



  • Compare treatment-related symptoms using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire in postmenopausal women with receptor-positive stage I, II, or IIIA primary breast cancer undergoing treatment with exemestane vs anastrozole with or without celecoxib on protocol CAN-NCIC-MA27.


  • Compare health-related quality of life using the FACT-ES questionnaire in patients treated with these regimens.
  • Determine the extent to which differences in treatment-emergent symptoms affect overall quality of life in patients treated with these regimens.

OUTLINE: This is a multicenter, companion study. Patients receive treatment on CAN-NCIC-MA27.

Health-related quality of life and treatment-related symptoms are assessed using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire at baseline and at 3, 6, 12, and 24 months.

PROJECTED ACCRUAL: A total of 1,253 patients will be accrued for this study.


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed invasive breast cancer

    • pT1-3; pNX, pN0-2 or pN3*; M0 NOTE: *Only when the sole basis for this classification is the presence of 10 or more involved axillary lymph nodes
  • Registered on protocol CAN-NCIC-MA27 within the past week
  • Hormone receptor status:

    • Estrogen receptor- and/or progesterone receptor-positive by immunohistochemistry or tumor receptor content ≥ 10 fmol/mg protein
    • At least 1 tumor must be receptor-positive in patients with bilateral breast cancer



  • Postmenopausal

Performance status

  • ECOG 0-2


  • Female

Menopausal status

  • Postmenopausal

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Able to read, understand, and complete quality of life questionnaires


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090974

  Show 224 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Study Chair: Lynne Wagner, MD Robert H. Lurie Cancer Center
Study Chair: Paul E. Goss, MD, PhD Massachusetts General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00090974     History of Changes
Other Study ID Numbers: CDR0000380937  ECOG-E1Z03  CAN-NCIC-E1Z03 
Study First Received: September 7, 2004
Last Updated: August 19, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Steroid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 25, 2016