Prevention of Chemotherapy Induced Ovarian Failure With Goserelin in BC Patients (ZORO) - Full Text View

Sponsored by:	German Breast Group
Information provided by:	German Breast Group
ClinicalTrials.gov Identifier:	NCT00196846

Purpose

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

Condition	Intervention	Phase
Breast Cancer	Drug: Goserelin	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Premature Ovarian Failure

Drug Information available for: Goserelin Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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

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
Estimated Study Completion Date:	February 2010
Estimated 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196846

Locations

Germany, Mecklenburg Vorpommern
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

Click here for more information about this study: ZORO Study This link exits the ClinicalTrials.gov site

Responsible Party:	GBG ( Christa Pfleiderer )
Study ID Numbers:	GBG37, Eudract Number: 2004-003980-62
Study First Received:	September 12, 2005
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00196846
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

Study placed in the following topic categories:

Skin Diseases
Gonadal Disorders
Goserelin
Breast Neoplasms
Endocrine System Diseases
Ovarian Failure, Premature
Ovarian Diseases
Genital Diseases, Female

Naphazoline
Deslorelin
Oxymetazoline
Guaifenesin
Phenylephrine
Phenylpropanolamine
Endocrinopathy
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009