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

German Breast Group (GBG) Research

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Goserelin

Study type

Interventional

Funder types

Other

Identifiers

NCT00196846

Eudract Number: 2004-003980-62

GBG37

Details and patient eligibility

About

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

Full 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

Enrollment

62 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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