Protection of Ovarian Function with Goserelin Acetate in Premenopausal Early Breast Cancer Patients with Chemotherapy - PROOF

Study identifier:D8664L00012

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

Protection of Ovarian Function with Goserelin Acetate in Premenopausal Early Breast Cancer Patients Undergoing Adjuvant Chemotherapy: An Open Label, Randomised, Multi-Centre, Phase IIIb Study

Medical condition

Breast Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Goserelin acetate

Sex

Female

Actual Enrollment

102

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: -
Estimated Primary Completion Date: 01 Apr 2012
Estimated Study Completion Date: 01 Apr 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Verification:

Verified 01 Dec 2010 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria