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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237327
• Other study ID #: 971-ONC-0028-094
• Secondary ID: A5991027
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2010
• Last updated: May 3, 2011
• Start date: November 2001
• Est. completion date: December 2009

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Megestrol acetate
Megestrol Acetate 160 mg oral tablets Qd
• exemestane (Aromasin)
exemestane (Aromasin) 25 mg oral tablets Qd

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing
China	PLA 307 Hospital	Beijing
China	Ba Yi Hospital, Cancer Center of CPLA	Nanjing
China	Jiangsu Cancer Hospital	Nanjing
China	Cancer Hospital	Shanghai
China	The 2nd Central Hospital of Tianjin	Tianjin
China	The 1st Affiliated Hospital, Xi'an Jiao Tong University	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival in months measured from date of starting treatment in core study to date of death for any reason.	Every 12 weeks up to 6 years	No
Secondary	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	Every 12 weeks up to 6 years	No
Secondary	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.	Every 12 weeks up to 6 years	No
Secondary	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.	Every 12 weeks up to 6 years	No
Secondary	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.	Every 12 weeks up to 6 years	No

External Links

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