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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Goserelin

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

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg Vorpommern
    • Rostock, Mecklenburg Vorpommern, Germany, 18075
      • Universitätsfrauenklinik, Rostock Universität

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures
• Complete baseline documentation sent to GBG
• Age of at least 18 and at most 45 years
• Patients request to preserve ovarian function
• Spontaneous and regular menstrual periods before study entry with FSH below 15 mlU/ml in follicular phase
• Histologically confirmed primary breast cancer with the need for anthracycline-based chemotherapy
• Steroid receptor (estrogen and progesterone) negative tumor (diagnosis according to hospital standard-procedures)
• No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated
• Karnofsky-Index >80%
• Life expectancy of at least 10 years, disregarding the diagnosis of cancer
• Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution
• Patients must be available for and compliant to treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center.

Exclusion Criteria:

• Known hypersensitivity reaction to the investigational compounds or incorporated substances
• Prior cytotoxic treatment for any reason
• Suspected (primary or secondary) ovarian insufficiency
• Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration and must implement adequate non-hormonal contraceptive measures during study treatment; prior use of hormonal contraceptives has to be discontinued before first Goserelin injection
• Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
• Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
• Concurrent treatment with other experimental drugs or any other anti-cancer therapy
• Concurrent treatment with sex hormones. Prior treatment must be stopped before study entry

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Normal ovarian function as defined by two consecutive menstrual periods within 21-35 days within a time frame of 5 - 8 months after last application of goserelin	December 2008

Secondary Outcome Measures

Outcome Measure	Time Frame
Discontinuation, delay, or dose-reductions of chemotherapy	December 2008
Discontinuation or delay of Goserelin injections	December 2008
Any grade II to grade IV AE specified to serious or non serious events during treatment with chemotherapy +/- Goserelin	December 2008
Evaluation according to EORTC Q 30	March 2010
According to menopausal symptom score: E2, FSH, LH, SHGB, and Progesterone at 0, 6, 12, 18 and 24 months	March 2010
Date of first regular menstrual period	March 2010
Any diagnosis of pregnancy during study follow up	March 2010

Collaborators and Investigators

• Sponsor: German Breast Group
• Investigators: Principal Investigator: Bernd Gerber, MD, Rostock Universität, Universitätsfrauenklinik

Publications and helpful links

Helpful Links

• Click here for more information about this study: ZORO Study

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): June 14, 2010
• Last Update Submitted That Met QC Criteria: June 11, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: hormone insensitive breast cancer; Prevention of Chemotherapy induced ovarian failure; P.O.F.; GnRH-Agonist Goserelin
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Goserelin
• Other Study ID Numbers: GBG37; Eudract Number: 2004-003980-62