Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01237327
First received: November 3, 2010
Last updated: May 3, 2011
Last verified: May 2011
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Purpose
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 megestrol : study 971-ONC-0028-080.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: Megestrol acetate Drug: exemestane (Aromasin) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Overall Survival [ Time Frame: Every 12 weeks up to 6 years ] [ Designated as safety issue: No ]Overall survival in months measured from date of starting treatment in core study to date of death for any reason.
Secondary Outcome Measures:
- Objective Response Rate (ORR) [ Time Frame: Every 12 weeks up to 6 years ] [ Designated as safety issue: No ]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
- Duration of Response (DR) [ Time Frame: Every 12 weeks up to 6 years ] [ Designated as safety issue: No ]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.
- Time to Tumor Progression (TTP) [ Time Frame: Every 12 weeks up to 6 years ] [ Designated as safety issue: No ]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.
- Time to Treatment Failure (TTF) [ Time Frame: Every 12 weeks up to 6 years ] [ Designated as safety issue: No ]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.
| Enrollment: | 84 |
| Study Start Date: | November 2001 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Megestrol acetate
Megestrol Acetate 160 mg oral tablets Qd
Other Name: Megace
|
| Experimental: 2 |
Drug: exemestane (Aromasin)
exemestane (Aromasin) 25 mg oral tablets Qd
Other Name: Aromasin
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Previous participation in study 971-ONC-0028-080.
Exclusion Criteria:
- Subjects who had not previously participated in study 971-ONC-0028-080.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237327
Locations
| China | |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | |
| Beijing, China, 100021 | |
| PLA 307 Hospital | |
| Beijing, China, 100039 | |
| Jiangsu Cancer Hospital | |
| Nanjing, China, 210009 | |
| Ba Yi Hospital, Cancer Center of CPLA | |
| Nanjing, China, 210002 | |
| Cancer Hospital | |
| Shanghai, China, 200032 | |
| The 2nd Central Hospital of Tianjin | |
| Tianjin, China, 300120 | |
| The 1st Affiliated Hospital, Xi'an Jiao Tong University | |
| Xi'an, China, 710061 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01237327 History of Changes |
| Other Study ID Numbers: | 971-ONC-0028-094, A5991027 |
| Study First Received: | November 3, 2010 |
| Results First Received: | December 7, 2010 |
| Last Updated: | May 3, 2011 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Pfizer:
|
Metastatic Breast Cancer Advanced Postmenopausal Exemestane vs Megestrol |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Megestrol Megestrol Acetate Exemestane Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Appetite Stimulants Central Nervous System Stimulants Central Nervous System Agents Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013