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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Megestrol Acetate 160 mg oral tablets Qd
exemestane (Aromasin) 25 mg oral tablets Qd
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
Overall Survival
Overall survival in months measured from date of starting treatment in core study to date of death for any reason.
Time frame: Every 12 weeks up to 6 years
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Every 12 weeks up to 6 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cancer Hospital
Shanghai, China
The 2nd Central Hospital of Tianjin
Tianjin, China
The 1st Affiliated Hospital, Xi'an Jiao Tong University
Xi'an, China