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Breast CancerPhase 2NCT00196846

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

A Phase 2 study testing Goserelin in people with Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study done in young breast cancer patients to prevent chemotherapy induced ovarian failure Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Goserelin
How many people
62 participants
Where
1 siteGermany
Study dates
Mar 2005to Mar 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsfrauenklinik, Rostock Universität

    Rostock, Mecklenburg-Vorpommern, 18075

Other trials in Germany

About this study

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

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

Read the 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
Conditions
Breast Cancer
Being tested
Goserelin
Keywords
hormone insensitive breast cancer, Prevention of Chemotherapy induced ovarian failure, P.O.F., GnRH-Agonist Goserelin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GoserelinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: December 2008

Secondary outcomes (7)

  1. Discontinuation, delay, or dose-reductions of chemotherapy

    Measured: December 2008

  2. Discontinuation or delay of Goserelin injections

    Measured: December 2008

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

    Measured: December 2008

  4. Evaluation according to EORTC Q 30

    Measured: March 2010

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

    Measured: March 2010

  6. Date of first regular menstrual period

    Measured: March 2010

  7. Any diagnosis of pregnancy during study follow up

    Measured: March 2010

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionDec 2008
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00196846
Sponsor's protocol ID
GBG37
Other IDs
Eudract Number: 2004-003980-62
Status last verified
Jun 2010
First submitted
12 Sep 2005
Last updated
14 Jun 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Goserelin in people with Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: December 2008). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00196846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2010.

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