Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Megestrol in Treating Hot Flashes Following Treatment for Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	Not specified	NCI	SWOG-S9626 NCI-P00-0159, NCT00005975

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.

Entry 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

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)

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

Expected Enrollment

A total of 279 patients (93 per treatment arm) will be accrued for this study 
over 3 years.

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.

Goodwin JW, Green SJ, Moinpour CM, et al.: Phase III randomized placebo-controlled trial of two doses of megestrol acetate as treatment for menopausal symptoms in women with breast cancer: Southwest Oncology Group Study 9626. J Clin Oncol 26 (10): 1650-6, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

John Goodwin, MD, Protocol chair		Ph: 417-269-4520 Email: jgoodwin@sprg.mercy.net

Registry Information
Official Title		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
Trial Start Date		2000-05-02
Trial Completion Date		2004-01-23
Registered in ClinicalTrials.gov		NCT00005975
Date Submitted to PDQ		2000-05-10
Information Last Verified		2009-01-27