Clinical trial NCT00196846: Prevention of Chemotherapy Induced Ovarian Failure With Goserelin in BC Patients (ZORO)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: hormone insensitive breast cancer
Prevention of Chemotherapy induced ovarian failure
P.O.F.
GnRH-Agonist Goserelin
Lead sponsor: GBG Forschungs GmbH
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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 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

Primary outcomes:
measure: 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
timeFrame: December 2008
Secondary outcomes:
measure: Discontinuation, delay, or dose-reductions of chemotherapy
timeFrame: December 2008
measure: Discontinuation or delay of Goserelin injections
timeFrame: December 2008
measure: Any grade II to grade IV AE specified to serious or non serious events during treatment with chemotherapy +/- Goserelin
timeFrame: December 2008
measure: Evaluation according to EORTC Q 30
timeFrame: March 2010
measure: According to menopausal symptom score: E2, FSH, LH, SHGB, and Progesterone at 0, 6, 12, 18 and 24 months
timeFrame: March 2010
measure: Date of first regular menstrual period
timeFrame: March 2010
measure: Any diagnosis of pregnancy during study follow up
timeFrame: March 2010
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Universitätsfrauenklinik, Rostock Universität
state: Mecklenburg Vorpommern
Study officials:
affiliation: Rostock Universität, Universitätsfrauenklinik
name: Bernd Gerber, MD
role: PRINCIPAL_INVESTIGATOR
References: