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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

Phase 2
18 Years
45 Years
Not Enrolling
Breast Cancer

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Trial Information

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 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

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

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome 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

Outcome Time Frame:

December 2008

Safety Issue:


Principal Investigator

Bernd Gerber, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rostock Universität, Universitätsfrauenklinik


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

March 2005

Completion Date:

March 2010

Related Keywords:

  • Breast Cancer
  • hormone insensitive breast cancer
  • Prevention of Chemotherapy induced ovarian failure
  • P.O.F.
  • GnRH-Agonist Goserelin
  • Breast Neoplasms
  • Menopause, Premature
  • Primary Ovarian Insufficiency