A Phase III Trial of Placebo Versus Megestrol Acetate 20 MG/Day Versus Megestrol Acetate 40 MG/Day as Treatment for Symptoms of Ovarian Failure in Women Treated for Breast Cancer: SWOG Study S9626
N/A
N/A
Female
Breast Cancer, Hot Flashes
Trial Information
A Phase III Trial of Placebo Versus Megestrol Acetate 20 MG/Day Versus Megestrol Acetate 40 MG/Day as Treatment for Symptoms of Ovarian Failure in Women Treated for Breast Cancer: SWOG Study S9626
OBJECTIVES: I. Compare the effectiveness and duration of the benefit of placebo versus low
dose megestrol versus high dose megestrol in the reduction of severe and/or frequent hot
flashes in patients with previously treated invasive breast cancer. II. Document the effects
of various dose levels of megestrol on atrophic vaginitis and dyspareunia in these patients.
III. Evaluate the toxicity of this treatment in these patients.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are stratified according to tamoxifen use (yes vs no), number of hot flashes per week (5-34
vs 35-63 vs more than 63), and duration of hot flashes (6 months or less vs longer than 6
months). Patients are randomized to one of three treatment arms. Arm I: Patients receive
oral placebo daily. Arm II: Patients receive lower dose oral megestrol daily. Arm III:
Patients receive higher dose oral megestrol daily. Patients who do not respond after 3
months of treatment receive an additional dose of oral megestrol daily. Treatment continues
for a total of 6 months in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 months.
PROJECTED ACCRUAL: A total of 279 eligible patients (93 per arm) are expected to be accrued.
Inclusion Criteria
DISEASE CHARACTERISTICS: Diagnosis of infiltrating breast cancer (T1-3, N0-1, M0) treated
with appropriate local and regional therapy Chemotherapy and/or surgery completed At least
10 hot flashes per week OR At least 5 severe or very severe hot flashes per week No prior
participation in NCI sponsored breast cancer adjuvant protocol No recurrent or persistent
vaginal bleeding If postmenopausal and had any vaginal bleeding within past year, then
must have normal endometrial biopsy Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Pre or postmenopausal
Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not
specified Hepatic: Not specified Renal: Not specified Cardiovascular: No history of deep
vein thrombosis Other: Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception No other prior malignancy in past 5 years except
adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the
cervix, or other adequately treated stage I or II cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No concurrent chemotherapy Endocrine therapy: Prior hormonal therapy
allowed At least 6 months since prior megestrol At least 1 week since prior nonestrogen
containing steroid hormones (except tamoxifen) Concurrent tamoxifen allowed only if begun
at least 4 months prior to study No other concurrent nonestrogen containing steroid
hormones No concurrent estrogen or hormone replacement therapy Radiotherapy: Concurrent
radiotherapy allowed Surgery: See Disease Characteristics Prior hysterectomy allowed No
concurrent surgery Other: Concurrent nonhormonal prescription or nonprescription
medications for hot flashes allowed (e.g., clonidine, ergotamine tartrate, vitamin E, or
soy)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Effectiveness and duration of the benefit of placebo and 2 dose levels of megestrol acetate in reduction of severe and/or frequent hot flashes in patients with history of adequate local and regional treatment of invasive breast cancer
Outcome Time Frame:
3, 6, and 9 months
Safety Issue:
No
Principal Investigator
John W. Goodwin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cancer Research for the Ozarks
Authority:
United States: Federal Government
Study ID:
CDR0000067962
NCT ID:
NCT00005975
Start Date:
April 1998
Completion Date:
March 2002
Related Keywords:
- Breast Cancer
- Hot Flashes
- stage I breast cancer
- stage II breast cancer
- hot flashes
- Breast Neoplasms
- Hot Flashes
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