Breast CancerPhase 3NCT00005975
S9626: Megestrol in Treating Hot Flashes Following Treatment for Breast Cancer
A Phase 3 study testing Megestrol Acetate 20mg/day and Megestrol Acetate 40 mg/day in people with Breast Cancer and Hot Flashes, run by SWOG Cancer Research Network.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 120 years, women only
- Conditions the study is for
- Breast Cancer, Hot Flashes
- What is being tested?
- Megestrol Acetate 20mg/day and Megestrol Acetate 40 mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Mar 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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)
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Hot Flashes
- Being tested
- Megestrol Acetate 20mg/day, Megestrol Acetate 40 mg/day, Megestrol Acetate Placebo 20 mg/day, Megestrol Acetate Placebo 40 mg/day
- Keywords
- stage I breast cancer, stage II breast cancer, hot flashes
- Medical subject headings
- Breast Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megestrol Acetate 20mg/dayDrug
Also called NSC-71423
Double blinded Megestrol Acetate 20 mg/day
Megestrol Acetate 40 mg/dayDrug
Also called NSC-71423
Double blinded Megestrol Acetate 40 mg/day
Megestrol Acetate Placebo 20 mg/dayDrug
Also called NSC-71423
Megestrol Acetate Placebo 20 mg/day
Megestrol Acetate Placebo 40 mg/dayDrug
Also called NSC-71423
Megestrol Acetate Placebo 40 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Megestrol Acetate 20mg/day; Drug: 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 Receives: Drug: Megestrol Acetate 40 mg/day; Drug: Megestrol Acetate Placebo 40 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3, 6, and 9 months
Secondary outcomes (3)
Document any effects of various dose levels of megestrol acetate on atrophic vaginitis and dyspareunia
Measured: 3, 6, and 9 months
Evaluate toxicity of two dose levels of megestrol acetate relative to placebo
Measured: 3, 6, and 9 months
Feasibility of accrual patients to placebo-controlled study
Measured: At registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2004 (estimated)
- Study startApr 1998
- Primary completionSep 2001
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John W. Goodwin, MD, Study chair, Cancer Research for the Ozarks
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005975
- Sponsor's protocol ID
- CDR0000067962
- Other IDs
- S9626, NCI-P00-0159, U10CA037429
- Status last verified
- Nov 2015
- First submitted
- 5 Jul 2000
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18375894
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00005975
- Acronym / sponsor ID
- CDR0000067962
- Conditions
- Breast Cancer, Hot Flashes
- Keywords
- stage I breast cancer, stage II breast cancer, hot flashes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1998
- Primary completion
- Sep 2001 (actual)
- Study completion
- Mar 2002 (actual)
- First posted
- 28 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Megestrol Acetate/Placebo 20 mg/day | Active comparator | Drug: Megestrol Acetate 20mg/day, Drug: Megestrol Acetate Placebo 20 mg/dayDouble blinded Megestrol Acetate 20 mg/day or Megestrol Acetate Placebo 20 mg/day taken for 3 months |
| Megestrol Acetate/Placebo 40 mg/day | Active comparator | Drug: Megestrol Acetate 40 mg/day, Drug: Megestrol Acetate Placebo 40 mg/dayDouble blinded Megestrol Acetate 40 mg/day or Megestrol Acetate Placebo 40 mg/day taken for 3 months |
Who may qualify
- Ages
- Up to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Megestrol Acetate 20mg/dayAlso: NSC-71423Double blinded Megestrol Acetate 20 mg/day | Drug | Megestrol Acetate/Placebo 20 mg/day |
| Megestrol Acetate 40 mg/dayAlso: NSC-71423Double blinded Megestrol Acetate 40 mg/day | Drug | Megestrol Acetate/Placebo 40 mg/day |
| Megestrol Acetate Placebo 20 mg/dayAlso: NSC-71423Megestrol Acetate Placebo 20 mg/day | Drug | Megestrol Acetate/Placebo 20 mg/day |
| Megestrol Acetate Placebo 40 mg/dayAlso: NSC-71423Megestrol Acetate Placebo 40 mg/day | Drug | Megestrol Acetate/Placebo 40 mg/day |
Primary outcome
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
3 secondary outcomes
Document any effects of various dose levels of megestrol acetate on atrophic vaginitis and dyspareunia
Time frame: 3, 6, and 9 months
Evaluate toxicity of two dose levels of megestrol acetate relative to placebo
Time frame: 3, 6, and 9 months
Feasibility of accrual patients to placebo-controlled study
Time frame: At registration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- Results publication: PubMed 18375894Goodwin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W. Goodwin, MD study chair
Cancer Research for the Ozarks
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Megestrol Acetate 20mg/day and Megestrol Acetate 40 mg/day in people with Breast Cancer and Hot Flashes, run by SWOG Cancer Research Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 3, 6, and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.