NCT01530607

Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Standard cyclophosphamide	AC (3 mos/4 cycles), CAF (6 mos/cycles), TAC (6 mos/cycles), CEF (6 mos/cycles) AC followed by taxane (6 mos/8 cycles), CMF (6 mos)
DRUG	Goserelin (Zoladex)	Chemotherapy in Arm 1 plus Goserelin given one week before first chemotherapy dose. Goserelin is given once every 4 weeks during chemo

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-02-10
• Last updated: 2016-02-25