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Prevention of Chemotherapy Induced Ovarian Failure With Goserelin in BC Patients (ZORO)

This study has been completed.
Information provided by:
German Breast Group Identifier:
First received: September 12, 2005
Last updated: June 11, 2010
Last verified: June 2010
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
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:

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 ]

Secondary Outcome Measures:
  • Discontinuation, delay, or dose-reductions of chemotherapy [ Time Frame: December 2008 ]
  • Discontinuation or delay of Goserelin injections [ Time Frame: December 2008 ]
  • Any grade II to grade IV AE specified to serious or non serious events during treatment with chemotherapy +/- Goserelin [ Time Frame: December 2008 ]
  • Evaluation according to EORTC Q 30 [ Time Frame: March 2010 ]
  • According to menopausal symptom score: E2, FSH, LH, SHGB, and Progesterone at 0, 6, 12, 18 and 24 months [ Time Frame: March 2010 ]
  • Date of first regular menstrual period [ Time Frame: March 2010 ]
  • Any diagnosis of pregnancy during study follow up [ Time Frame: March 2010 ]

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)
Detailed Description:

Study Design:

Prospective, randomized, open phase II trial


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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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
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Please refer to this study by its identifier: NCT00196846

Universitätsfrauenklinik, Rostock Universität
Rostock, Mecklenburg Vorpommern, Germany, 18075
Sponsors and Collaborators
German Breast Group
Principal Investigator: Bernd Gerber, MD Rostock Universität, Universitätsfrauenklinik
  More Information

Additional Information:
Responsible Party: Konstantin Reißmüller, GBG 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

Keywords provided by German Breast Group:
hormone insensitive breast cancer
Prevention of Chemotherapy induced ovarian failure
GnRH-Agonist Goserelin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on April 21, 2017