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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196846
• Other study ID #: GBG37
• Secondary ID: Eudract Number:
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: June 11, 2010
• Start date: March 2005
• Est. completion date: March 2010

Study information

• Verified date: June 2010
• Source: German Breast Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Goserelin

Locations

Country	Name	City	State
Germany	Universitätsfrauenklinik, Rostock Universität	Rostock	Mecklenburg Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
German Breast Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Discontinuation, delay, or dose-reductions of chemotherapy		December 2008	No
Secondary	Discontinuation or delay of Goserelin injections		December 2008	No
Secondary	Any grade II to grade IV AE specified to serious or non serious events during treatment with chemotherapy +/- Goserelin		December 2008	Yes
Secondary	Evaluation according to EORTC Q 30		March 2010	No
Secondary	According to menopausal symptom score: E2, FSH, LH, SHGB, and Progesterone at 0, 6, 12, 18 and 24 months		March 2010	No
Secondary	Date of first regular menstrual period		March 2010	No
Secondary	Any diagnosis of pregnancy during study follow up		March 2010	No

External Links

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