E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
-young hormone insensitive breast cancer patients receiving anthracycline containing (neo-)adjuvant chemotherapy |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• 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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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;
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The reason and date of Goserelin discontinuation for all patients will be documented on the case report form (e.g. completed study, progressive disease, death, adverse event, withdrawal of consent, lost to follow-up, etc.). Patients without proven ovarian suppression should discontinue study medication treatment with Goselerin. The investigator will attempt to complete all discharge procedures at the time a patient is withdrawn from
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |