Breast Cancer
Conditions
Keywords
hormone insensitive breast cancer, Prevention of Chemotherapy induced ovarian failure, P.O.F., GnRH-Agonist Goserelin
Brief 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
Interventions
DRUGGoserelin
Sponsors
GBG Forschungs GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Discontinuation, delay, or dose-reductions of chemotherapy | December 2008 |
| Date of first regular menstrual period | March 2010 |
| Any diagnosis of pregnancy during study follow up | March 2010 |
| According to menopausal symptom score: E2, FSH, LH, SHGB, and Progesterone at 0, 6, 12, 18 and 24 months | March 2010 |
Countries
Germany
Outcome results
None listed