Metastatic Breast CancerPhase 3NCT01237327

Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer

A Phase 3 study testing Megestrol acetate and exemestane (Aromasin) in people with Metastatic Breast Cancer, run by Pfizer at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women with natural or induced postmenopausal status with advanced breast cancer whose disease has progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had participated on an original study of exemestane vs… Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Metastatic Breast Cancer
What is being tested?: Megestrol acetate and exemestane (Aromasin)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 7 sitesChina
Study dates: Nov 2001to Dec 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Previous participation in study 971-ONC-0028-080.

Who cannot join

Subjects who had not previously participated in study 971-ONC-0028-080.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

China7 sites

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
PLA 307 Hospital
Beijing, 100039
Ba Yi Hospital, Cancer Center of CPLA
Nanjing, 210002
Jiangsu Cancer Hospital
Nanjing, 210009
Cancer Hospital
Shanghai, 200032
The 2nd Central Hospital of Tianjin
Tianjin, 300120
The 1st Affiliated Hospital, Xi'an Jiao Tong University
Xi'an, 710061

Other trials in China

About this study

Official title: Follow-up of the Study 971-ONC-0028-080: Exemestane Versus Megestrol Acetate In Postmenopausal Patients With Metastatic Breast Cancer, Failing Anti-Estrogens: An Open-Label, Randomized, Parallel-Group, Phase III Comparative Study

Conditions: Metastatic Breast Cancer
Being tested: Megestrol acetate, exemestane (Aromasin)
Keywords: Metastatic Breast Cancer, Advanced, Postmenopausal, Exemestane vs Megestrol
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Megestrol acetateDrug
Also called Megace
Megestrol Acetate 160 mg oral tablets Qd
exemestane (Aromasin)Drug
Also called Aromasin
exemestane (Aromasin) 25 mg oral tablets Qd

Study groups in NCT01237327
Study group	Role	What they receive
1	Active comparator	Not described Receives: Drug: Megestrol acetate
2	Experimental	Not described Receives: Drug: exemestane (Aromasin)

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival
Overall survival in months measured from date of starting treatment in core study to date of death for any reason.
Measured: Every 12 weeks up to 6 years

Secondary outcomes (4)

Objective Response Rate (ORR)
Percentage of participants achieving an objective response (OR) defined as complete response (CR) or partial response (PR) out of the total number of participants randomized in each treatment group
Measured: Every 12 weeks up to 6 years
Duration of Response (DR)
Duration of objective response (complete response [CR] or partial response [PR]) calculated from date objective response was first documented to date of progressive disease. For subjects proceeding from PR to CR, the onset of PR was taken as the onset of objective response.
Measured: Every 12 weeks up to 6 years
Time to Tumor Progression (TTP)
TTP = time between first day of study treatment and date of documented disease progression, or date of tumor-related death in the absence of previously documented progressive disease (PD). PD defined as a 25% or greater increase in size of 1 or more lesions compared to smallest previous assessment, or appearance of new lesion, or unequivocal worsening of bone lesions, or progression of nonevaluable lesions.
Measured: Every 12 weeks up to 6 years
Time to Treatment Failure (TTF)
TTF = time between first day of study treatment and date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death from any cause, whichever was the earliest event.
Measured: Every 12 weeks up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2001Dec 2009

First posted9 Nov 2010 (estimated)
Study startNov 2001
Primary completionDec 2007
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Treatment
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01237327
Sponsor's protocol ID: 971-ONC-0028-094
Other IDs: A5991027
Status last verified: May 2011
First submitted: 3 Nov 2010
Last updated: 6 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metastatic Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Follow-up of the Study 971-ONC-0028-080: Exemestane Versus Megestrol Acetate In Postmenopausal Patients With Metastatic Breast Cancer, Failing Anti-Estrogens: An Open-Label, Randomized, Parallel-Group, Phase III Comparative Study
ClinicalTrials.gov ID: NCT01237327
Acronym / sponsor ID: 971-ONC-0028-094
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer, Advanced, Postmenopausal, Exemestane vs Megestrol
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2001
Primary completion: Dec 2007 (actual)
Study completion: Dec 2009 (actual)
First posted: 9 Nov 2010 (estimated)
Results: Posted 14 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Megestrol acetate
2	Experimental	Drug: exemestane (Aromasin)

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Previous participation in study 971-ONC-0028-080.

Key exclusion criteria (1 listed)

Subjects who had not previously participated in study 971-ONC-0028-080.

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 acetateAlso: MegaceMegestrol Acetate 160 mg oral tablets Qd	Drug	1
exemestane (Aromasin)Also: Aromasinexemestane (Aromasin) 25 mg oral tablets Qd	Drug	2

Primary outcome

Overall Survival
Time frame: Every 12 weeks up to 6 years
Overall survival in months measured from date of starting treatment in core study to date of death for any reason.

4 secondary outcomes

Objective Response Rate (ORR)
Time frame: Every 12 weeks up to 6 years
Duration of Response (DR)
Time frame: Every 12 weeks up to 6 years
Time to Tumor Progression (TTP)
Time frame: Every 12 weeks up to 6 years
Time to Treatment Failure (TTF)
Time frame: Every 12 weeks up to 6 years

Results and safety

Results posted to the registry on 14 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exemestane	43	1
Megestrol Acetate	41	1

Primary outcome: Overall Survival

Time frame: Every 12 weeks up to 6 years. Median (95% Confidence Interval). Unit: months

Measure	Exemestane n = 43	Megestrol Acetate n = 41
Value	29.2 (22.9 to 47.8)	16.3 (11.6 to 27.6)

Exemestane vs Megestrol Acetate: Hazard Ratio (HR): 0.7799 (95% CI 0.47 to 1.294), p = 0.3348, Log Rank

Population analysed: Intent-to-treat (ITT): participants randomized to study medication in core study who consented to participation in extension study.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exemestane	1 of 41 (2.4%)	24 of 41 (58.5%)	Not reported
Megestrol Acetate	2 of 40 (5%)	25 of 40 (62.5%)	Not reported

Limitations and caveats (from the sponsor): At the time of study completion in 2007, via protocol amendment participants still on treatment were allowed to continue treatment, being monitored for Serious Adverse Events (SAE) only. The final participant discontinued in 2009.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Metastatic Breast Cancer

RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
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Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
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RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
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RecruitingPhase 1/2
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Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma

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.

Pfizer CT.gov Call Center study director

Pfizer

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Megestrol acetate and exemestane (Aromasin) in people with Metastatic Breast Cancer, run by Pfizer at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. 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 6 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 14 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (time frame: Every 12 weeks up to 6 years). 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 NCT01237327.

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 6 May 2011.