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

This study is ongoing, but not recruiting participants.

First Received: September 7, 2004 Last Updated: February 6, 2009 History of Changes

Sponsors and Collaborators:	Eastern Cooperative Oncology Group National Cancer Institute (NCI) National Cancer Institute of Canada
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00090974

Purpose

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 Cancer-Related Problem/Condition	Procedure: quality-of-life assessment

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Exemestane Anastrozole Celecoxib

U.S. FDA Resources

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

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

Study Start Date:

December 2004

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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)

National Cancer Institute of Canada

Investigators

Study Chair:	Lynne Wagner, MD	Robert H. Lurie Cancer Center
Study Chair:	Paul E. Goss, MD, PhD	Massachusetts General Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. Epub 2008 Mar 31.

Study ID Numbers:	CDR0000380937, ECOG-E1Z03, CAN-NCIC-E1Z03
Study First Received:	September 7, 2004
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00090974 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

quality of life
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Study placed in the following topic categories:

Anastrozole
Celecoxib
Antineoplastic Agents, Hormonal
Skin Diseases
Quality of Life

Breast Neoplasms
Exemestane
Aromatase Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Anastrozole
Skin Diseases
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms
Enzyme Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009