An Open Label, Randomized Multicenter Comparative Trial Of 5 Years Adjuvant Exemestane Treatment Versus 5 Years Adjuvant Tamoxifen Treatment In Postmenopausal Women With Early Breast Cancer
N/A
N/A
Female
Breast Cancer
Trial Information
An Open Label, Randomized Multicenter Comparative Trial Of 5 Years Adjuvant Exemestane Treatment Versus 5 Years Adjuvant Tamoxifen Treatment In Postmenopausal Women With Early Breast Cancer
OBJECTIVES:
- Compare the efficacy and tolerability of adjuvant exemestane versus adjuvant tamoxifen
in postmenopausal women with early breast cancer.
- Compare the relapse-free survival and overall survival of patients treated with these
drugs.
- Compare the incidence of contralateral breast cancer in patients treated with these
drugs.
- Compare the safety and long-term tolerability of these drugs in these patients.
- Compare the quality of life of patients treated with these drugs.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to estrogen receptor (ER)/progesterone receptor (PgR) status (ER positive vs ER
negative/PgR positive vs ER positive/PgR unknown), prior chemotherapy (none vs taxane-based
vs anthracycline-based vs other), and nodal status (negative vs 1-3 nodes positive vs 4 or
more nodes positive). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral tamoxifen once daily
- Arm II: Patients receive oral exemestane once daily. Treatment in both arms continues
for a minimum of 5 years in the absence of disease progression or unacceptable
toxicity.
Quality of life is assessed at baseline and at months 3 and 12 during study.
Patients are followed at least annually.
PROJECTED ACCRUAL: Approximately 4,400 patients (2,200 per treatment arm) will be accrued
for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed early adenocarcinoma of the breast
- Completely excised by surgery with curative intent (R0)
- Any N OR
- Any primary tumor greater than 3 cm OR
- Any primary tumor grade III and greater than 1 cm
- M0
- No positive supraclavicular nodes
- Hormone receptor status:
- Estrogen and/or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age:
- Any age
- See Menopausal status
Sex:
- Female
Menopausal status:
- Postmenopausal
- Any age with bilateral oophorectomy or amenorrhea for at least 5 years OR
- Age 50 or over:
- Natural amenorrhea for at least 1 year OR
- Chemotherapy-induced amenorrhea for at least 2 years OR
- Radiation-induced amenorrhea (at least 3 months since prior radiotherapy)
OR
- Under age 50:
- If amenorrheic for less than 5 years (any cause) or prior hysterectomy
without bilateral surgical oophorectomy, follicle-stimulating hormone must
be assayed to confirm postmenopausal status
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count greater than 100,000/mm3
- WBC greater than 3,000/mm3
Hepatic:
- SGOT or SGPT less than 2.5 times upper limit of normal (ULN)
Renal:
- Creatinine less than 1.5 times ULN
Cardiovascular:
- No uncontrolled cardiac disease
- No unstable angina
- No congestive heart failure or arrhythmia requiring medical therapy
- No myocardial infarction within the past 3 months
Other:
- No severe osteoporosis
- No other malignancies within the past 5 years except adequately treated carcinoma in
situ of the cervix or basal cell skin cancer
- No other serious concurrent disease that would preclude study
- No psychiatric disorders that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior neoadjuvant chemotherapy
- No more than 10 weeks since completion of prior adjuvant chemotherapy
Endocrine therapy:
- No prior adjuvant hormonal therapy for breast cancer
- No prior neoadjuvant hormonal therapy (prior to surgery) for duration of more than 4
weeks
- At least 4 weeks since prior hormone replacement therapy
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
- No more than 10 weeks since completion of curative surgery
Other:
- No other concurrent investigational agents or participation in another clinical study
(except adjuvant cytotoxic chemotherapy studies)
- Concurrent bisphosphonates allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Relapse-free survival
Safety Issue:
No
Principal Investigator
Daniel Rea, MD
Investigator Role:
Study Chair
Investigator Affiliation:
City Hospital - Birmingham
Authority:
United States: Federal Government
Study ID:
CDR0000069260
NCT ID:
NCT00032136
Start Date:
December 2001
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- Breast Neoplasms
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