Skip to main content
OpenTrials
Completed

NCT Number: NCT00090974

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

0 year–120 year

Sex eligibility

Female

Study type

Observational

Primary location

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital, Fairbanks, Alaska, United States

Loading trial locations.

About this study

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Postmenopausal

Performance status

  • ECOG 0-2

Sex

  • Female

Menopausal status

  • Postmenopausal

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Treatment and study plan

quality-of-life assessment

Procedure

Sponsors and collaborators

Lead sponsor

Eastern Cooperative Oncology Group

Network

Collaborators

  • NCIC Clinical Trials Group
  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Sep 8, 2004
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.