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

NCT01237327 | Completed Phase 3 Results

• 2 other identifiers: 971-ONC-0028-094A5991027
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 7

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.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; Advanced; Postmenopausal; Exemestane vs Megestrol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Every 12 weeks up to 6 years

• Duration of Response (DR)

  Every 12 weeks up to 6 years

• Time to Tumor Progression (TTP)

  Every 12 weeks up to 6 years

• Time to Treatment Failure (TTF)

  Every 12 weeks up to 6 years

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Megestrol acetate

2

EXPERIMENTAL

Drug: exemestane (Aromasin)

Interventions

Megestrol acetate DRUG

Megestrol Acetate 160 mg oral tablets Qd

Also known as: Megace

1

exemestane (Aromasin) DRUG

exemestane (Aromasin) 25 mg oral tablets Qd

Also known as: Aromasin

2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

PLA 307 Hospital

Beijing, 100039, China

Location

Ba Yi Hospital, Cancer Center of CPLA

Nanjing, 210002, China

Location

Jiangsu Cancer Hospital

Nanjing, 210009, China

Location

Cancer Hospital

Shanghai, 200032, China

Location

The 2nd Central Hospital of Tianjin

Tianjin, 300120, China

Location

The 1st Affiliated Hospital, Xi'an Jiao Tong University

Xi'an, 710061, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Megestrol Acetate; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

At the time of study completion in 2007, via protocol amendment participants still on treatment were allowed to continue treatment, being monitored for Serious Adverse Events (SAE) only. The final participant discontinued in 2009.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 9, 2010
• Study Start: November 1, 2001
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2009
• Last Updated: May 6, 2011
• Results First Posted: March 14, 2011

Record last verified: 2011-05

Locations

CN (7)