Prevention of Chemotherapy Induced Ovarian Failure With Goserelin in BC Patients (ZORO)
This study has been completed.
Sponsor:
German Breast Group
Information provided by:
German Breast Group
ClinicalTrials.gov Identifier:
NCT00196846
First received: September 12, 2005
Last updated: June 11, 2010
Last verified: June 2010
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Purpose
Study done in young breast cancer patients to prevent chemotherapy induced ovarian failure
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Goserelin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
fragile X-associated primary ovarian insufficiency
U.S. FDA Resources
Further study details as provided by German Breast Group:
Primary Outcome Measures:
- 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 [ Time Frame: December 2008 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Discontinuation, delay, or dose-reductions of chemotherapy [ Time Frame: December 2008 ] [ Designated as safety issue: No ]
- Discontinuation or delay of Goserelin injections [ Time Frame: December 2008 ] [ Designated as safety issue: No ]
- Any grade II to grade IV AE specified to serious or non serious events during treatment with chemotherapy +/- Goserelin [ Time Frame: December 2008 ] [ Designated as safety issue: Yes ]
- Evaluation according to EORTC Q 30 [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
- According to menopausal symptom score: E2, FSH, LH, SHGB, and Progesterone at 0, 6, 12, 18 and 24 months [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
- Date of first regular menstrual period [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
- Any diagnosis of pregnancy during study follow up [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 62 |
| Study Start Date: | March 2005 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196846
Locations
| Germany | |
| Universitätsfrauenklinik, Rostock Universität | |
| Rostock, Mecklenburg Vorpommern, Germany, 18075 | |
Sponsors and Collaborators
German Breast Group
Investigators
| Principal Investigator: | Bernd Gerber, MD | Rostock Universität, Universitätsfrauenklinik |
More Information
Additional Information:
No publications provided
| Responsible Party: | Konstantin Reißmüller, GBG |
| ClinicalTrials.gov Identifier: | NCT00196846 History of Changes |
| Other Study ID Numbers: | GBG37, Eudract Number: 2004-003980-62 |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 11, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by German Breast Group:
|
hormone insensitive breast cancer Prevention of Chemotherapy induced ovarian failure P.O.F. GnRH-Agonist Goserelin |
Additional relevant MeSH terms:
|
Breast Neoplasms Menopause, Premature Primary Ovarian Insufficiency Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Goserelin Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 16, 2012
