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S9626: Megestrol in Treating Hot Flashes Following Treatment for Breast Cancer

Primary Purpose

Breast Cancer, Hot Flashes

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Megestrol Acetate 20mg/day
Megestrol Acetate 40 mg/day
Megestrol Acetate Placebo 20 mg/day
Megestrol Acetate Placebo 40 mg/day
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, hot flashes

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Megestrol Acetate/Placebo 20 mg/day

    Megestrol Acetate/Placebo 40 mg/day

    Arm Description

    Double blinded Megestrol Acetate 20 mg/day or Megestrol Acetate Placebo 20 mg/day taken for 3 months

    Double blinded Megestrol Acetate 40 mg/day or Megestrol Acetate Placebo 40 mg/day taken for 3 months

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Document any effects of various dose levels of megestrol acetate on atrophic vaginitis and dyspareunia
    Evaluate toxicity of two dose levels of megestrol acetate relative to placebo
    Feasibility of accrual patients to placebo-controlled study

    Full Information

    First Posted
    July 5, 2000
    Last Updated
    November 17, 2015
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005975
    Brief Title
    S9626: Megestrol in Treating Hot Flashes Following Treatment for Breast Cancer
    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: SWOG Study S9626
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1998 (undefined)
    Primary Completion Date
    September 2001 (Actual)
    Study Completion Date
    March 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Megestrol may be effective in treating hot flashes following treatment for breast cancer. It is not yet known which regimen of megestrol is most effective for hot flashes. PURPOSE: Randomized phase III trial to compare the effectiveness of different doses of megestrol in treating hot flashes in patients who have undergone therapy for breast cancer.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Hot Flashes
    Keywords
    stage I breast cancer, stage II breast cancer, hot flashes

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    288 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Megestrol Acetate/Placebo 20 mg/day
    Arm Type
    Active Comparator
    Arm Description
    Double blinded Megestrol Acetate 20 mg/day or Megestrol Acetate Placebo 20 mg/day taken for 3 months
    Arm Title
    Megestrol Acetate/Placebo 40 mg/day
    Arm Type
    Active Comparator
    Arm Description
    Double blinded Megestrol Acetate 40 mg/day or Megestrol Acetate Placebo 40 mg/day taken for 3 months
    Intervention Type
    Drug
    Intervention Name(s)
    Megestrol Acetate 20mg/day
    Other Intervention Name(s)
    NSC-71423
    Intervention Description
    Double blinded Megestrol Acetate 20 mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Megestrol Acetate 40 mg/day
    Other Intervention Name(s)
    NSC-71423
    Intervention Description
    Double blinded Megestrol Acetate 40 mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Megestrol Acetate Placebo 20 mg/day
    Other Intervention Name(s)
    NSC-71423
    Intervention Description
    Megestrol Acetate Placebo 20 mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Megestrol Acetate Placebo 40 mg/day
    Other Intervention Name(s)
    NSC-71423
    Intervention Description
    Megestrol Acetate Placebo 40 mg/day
    Primary Outcome Measure Information:
    Title
    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
    Time Frame
    3, 6, and 9 months
    Secondary Outcome Measure Information:
    Title
    Document any effects of various dose levels of megestrol acetate on atrophic vaginitis and dyspareunia
    Time Frame
    3, 6, and 9 months
    Title
    Evaluate toxicity of two dose levels of megestrol acetate relative to placebo
    Time Frame
    3, 6, and 9 months
    Title
    Feasibility of accrual patients to placebo-controlled study
    Time Frame
    At registration

    10. Eligibility

    Sex
    Female
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John W. Goodwin, MD
    Organizational Affiliation
    Cancer Research for the Ozarks
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18375894
    Citation
    Goodwin JW, Green SJ, Moinpour CM, Bearden JD 3rd, Giguere JK, Jiang CS, Lippman SM, Martino S, Albain KS. 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. 2008 Apr 1;26(10):1650-6. doi: 10.1200/JCO.2006.10.6179.
    Results Reference
    result

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    S9626: Megestrol in Treating Hot Flashes Following Treatment for Breast Cancer

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