Skip to main content
OpenTrials
Completed

NCT Number: NCT01237327

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Megestrol acetate

Drug

Megestrol Acetate 160 mg oral tablets Qd

Other names: Megace

exemestane (Aromasin)

Drug

exemestane (Aromasin) 25 mg oral tablets Qd

Other names: Aromasin

Primary outcomes

  1. 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.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 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

  2. Duration of Response (DR)

    Time frame: 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.

  3. Time to Tumor Progression (TTP)

    Time frame: 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.

  4. Time to Treatment Failure (TTF)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2007
Study completion
2009
First posted
Nov 9, 2010
Registry last updated
May 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.