NCT00196846

Brief Summary

Study done in young breast cancer patients to prevent chemotherapy induced ovarian failure

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Mar 2005

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 14, 2010

Status Verified

June 1, 2010

Enrollment Period

3.8 years

First QC Date

September 12, 2005

Last Update Submit

June 11, 2010

Conditions

Breast Cancer

Keywords

hormone insensitive breast cancerPrevention of Chemotherapy induced ovarian failureP.O.F.GnRH-Agonist Goserelin

Outcome Measures

Primary Outcomes (1)

  • 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

    December 2008

Secondary Outcomes (7)

  • Discontinuation, delay, or dose-reductions of chemotherapy

    December 2008

  • Discontinuation or delay of Goserelin injections

    December 2008

  • Any grade II to grade IV AE specified to serious or non serious events during treatment with chemotherapy +/- Goserelin

    December 2008

  • Evaluation according to EORTC Q 30

    March 2010

  • According to menopausal symptom score: E2, FSH, LH, SHGB, and Progesterone at 0, 6, 12, 18 and 24 months

    March 2010

  • +2 more secondary outcomes

Interventions

GoserelinDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsfrauenklinik, Rostock Universität

Rostock, Mecklenburg-Vorpommern, 18075, Germany

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Bernd Gerber, MD

    Rostock Universität, Universitätsfrauenklinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

March 1, 2005

Primary Completion

December 1, 2008

Study Completion

March 1, 2010

Last Updated

June 14, 2010

Record last verified: 2010-06

Locations

DE(1)