None listed
Conditions
Interventions
Product Name: Zoladex
Product Code: 19711.00.00
Pharmaceutical Form: Injection*
INN or Proposed INN: Goselerinacetate
Other descriptive name: Zoladex
Concentration unit: mg/g milligram(s)/gram
Concent
Sponsors
GBG Forschungs GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 regulary 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-proceedures); • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 concommittant 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 |
|---|---|
| Main Objective: • To increase the percentage of patients with normal ovarian function at 6 months after applicaton of (neo)adjuvant, anthracycline-containing polychemotherapy in parallel with Goserelin compared to chemotherapy alone.;Primary end point(s): 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;Secondary Objective: 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 • Determination of the ovarian reserve by vaginal ultrasound and blood hormone measurements for FSH, Estradiol, Anti-Mullerian Hormone (AMH) and Inhibin B after End of Chemotherapy (EOC)/End of Goserelin treatment (EOGT) at one point of time during follow-up • Pregnancy rate | — |
Countries
Germany
Outcome results
None listed