NCT00196846

Prevention of Chemotherapy Induced Ovarian Failure With Goserelin in BC Patients (ZORO)

Prospective Randomized Multicenter Study to Prevent Chemotherapy Induced Ovarian Failure With the GnRH-Agonist Goserelin in Young Hormone Insensitive Breast Cancer Patients Receiving Anthracycline Containing (Neo-)Adjuvant Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: GBG Forschungs GmbH · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Study done in young breast cancer patients to prevent chemotherapy induced ovarian failure

Detailed description

Study Design: Prospective, randomized, open phase II trial Schedule: All patients will receive an anthracycline-containing polychemotherapy. Patients randomized to Goserelin will receive their first injection of 3.6 mg at least 2 weeks before start of chemotherapy. Goserelin will be given as a subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) until the end of the last chemotherapy cycle. Primary objective: •To increase the percentage of patients with normal ovarian function at 6 months after application of (neo)adjuvant, anthracycline-containing polychemotherapy in parallel with Goserelin compared to chemotherapy alone. Secondary objectives: To compare the two treatment groups regarding * Compliance to treatment * Toxicity * Quality of life * Menopausal Symptoms Score * Ovarian function at 6, 12, 18 and 24 months * Duration until recovery of regular menstrual period * Pregnancy rate

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Goserelin

Timeline

• Start date: 2005-03-01
• Primary completion: 2008-12-01
• Completion: 2010-03-01
• First posted: 2005-09-20
• Last updated: 2010-06-14

Locations

1 site across 1 country: Germany