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

Phase 3

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: exemestane (Aromasin); Drug: Megestrol acetate

• Registration Number: NCT01237327
• Lead Sponsor: Pfizer

Brief 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 megestrol : study 971-ONC-0028-080.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2007-12
• Study Completion: 2009-12
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-09
• Results First Submitted: 2010-12-07
• Results First Submitted QC: 2011-02-17
• Results First Posted: 2011-03-14
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-03
• Last Update Posted: 2011-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	exemestane (Aromasin)	-
1	Megestrol acetate	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	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.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Every 12 weeks up to 6 years	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)	Every 12 weeks up to 6 years	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)	Every 12 weeks up to 6 years	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)	Every 12 weeks up to 6 years	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.

Trial Locations

Locations (7)

The 2nd Central Hospital of Tianjin; 🇨🇳 Tianjin, China

Cancer Hospital; 🇨🇳 Shanghai, China

The 1st Affiliated Hospital, Xi'an Jiao Tong University; 🇨🇳 Xi'an, China

PLA 307 Hospital; 🇨🇳 Beijing, China

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

Ba Yi Hospital, Cancer Center of CPLA; 🇨🇳 Nanjing, China

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, China