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

This study has been completed.
Sponsor:
Information provided by:
German Breast Group
ClinicalTrials.gov Identifier:
NCT00196846
First received: September 12, 2005
Last updated: June 11, 2010
Last verified: June 2010
  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:


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)
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Adnexal Diseases
Breast Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Skin Diseases
Goserelin
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014