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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

Open (Enrolling)
Breast Cancer

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Trial Information

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



- 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

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.

Inclusion Criteria


- 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



- 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

Type of Study:


Study Design:


Principal Investigator

Lynne Wagner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms



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