NCT00005975

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Apr 1998

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2001

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

June 28, 2004

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

3.4 years

First QC Date

July 5, 2000

Last Update Submit

November 17, 2015

Conditions

Breast CancerHot Flashes

Keywords

stage I breast cancerstage II breast cancerhot flashes

Outcome Measures

Primary Outcomes (1)

  • 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

    3, 6, and 9 months

Secondary Outcomes (3)

  • Document any effects of various dose levels of megestrol acetate on atrophic vaginitis and dyspareunia

    3, 6, and 9 months

  • Evaluate toxicity of two dose levels of megestrol acetate relative to placebo

    3, 6, and 9 months

  • Feasibility of accrual patients to placebo-controlled study

    At registration

Study Arms (2)

Megestrol Acetate/Placebo 20 mg/day

ACTIVE COMPARATOR

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

Drug: Megestrol Acetate 20mg/dayDrug: Megestrol Acetate Placebo 20 mg/day

Megestrol Acetate/Placebo 40 mg/day

ACTIVE COMPARATOR

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

Drug: Megestrol Acetate 40 mg/dayDrug: Megestrol Acetate Placebo 40 mg/day

Interventions

Megestrol Acetate 20mg/dayDRUG

Double blinded Megestrol Acetate 20 mg/day

Also known as: NSC-71423
Megestrol Acetate/Placebo 20 mg/day
Megestrol Acetate 40 mg/dayDRUG

Double blinded Megestrol Acetate 40 mg/day

Also known as: NSC-71423
Megestrol Acetate/Placebo 40 mg/day
Megestrol Acetate Placebo 20 mg/dayDRUG

Megestrol Acetate Placebo 20 mg/day

Also known as: NSC-71423
Megestrol Acetate/Placebo 20 mg/day
Megestrol Acetate Placebo 40 mg/dayDRUG

Megestrol Acetate Placebo 40 mg/day

Also known as: NSC-71423
Megestrol Acetate/Placebo 40 mg/day

Eligibility Criteria

AgeUp to 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18375894RESULT

MeSH Terms

Conditions

Breast NeoplasmsHot Flashes

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • John W. Goodwin, MD

    Cancer Research for the Ozarks

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

June 28, 2004

Study Start

April 1, 1998

Primary Completion

September 1, 2001

Study Completion

March 1, 2002

Last Updated

November 18, 2015

Record last verified: 2015-11