Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00888082

Purpose

Primary objective of this study is to determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses via menstrual history, serum FSH and E2 measurements.

The secondary objectives of this study are as follows: To investigate the impact of treatment with chemotherapy with or without goserelin acetate (i.e.

impact of the expectation of ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and to compare safety and tolerability of study drugs in two treatment groups by evaluation of adverse events.

Condition	Intervention	Phase
Breast Cancer Ovarian Function	Drug: Goserelin acetate	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menstruation

Drug Information available for: Goserelin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients Undergoing Adjuvant Chemotherapy: An Open Label, Randomised, Multi-Centre, Phase IIIb Study

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The ovarian function will be considered as regained, if E2 measurements return to premenopausal levels (equal to or above 20 pg/ml), FSH measurements return to premenopausal levels (less than or equal to 40 IU/L) [ Time Frame: Each 3 months ] [ Designated as safety issue: No ]
The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles [ Time Frame: Each 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life (QOL) through-out the study measured by FACT-ES scale. [ Time Frame: Each 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	102
Study Start Date:	April 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: No Intervention Patients receiving only adjuvant chemotherapy
B: Experimental Patient receiving goserelin acetate along with adjuvant chemotherapy	Drug: Goserelin acetate 3.6 mg depot injectable preparation

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pathologically confirmed invasive breast carcinoma
Candidates for adjuvant chemotherapy for primary breast cancer
Premenopausal, verified before chemotherapy is begun as satisfying both cyclic vaginal bleeding and appropriate hormone levels

Exclusion Criteria:

Previous systemic chemotherapy
Pregnancy
Stage IV breast cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888082

Contacts

Contact: AstraZeneca Turkey Clinical Study Information

+90 212 317 2386

zeynep.goztas@astrazeneca.com

Locations

Turkey
Research Site	Recruiting
Istanbul, Turkey
Research Site	Recruiting
Ankara, Turkey
Research Site	Recruiting
Kayseri, Turkey

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:	Mustafa Özgüroğlu, Assoc.Prof.	Istanbul University Cerrahpasa Medical Faculty, Medical Oncology Clinic, Cerrahpasa 34098, Istanbul, Turkey
Principal Investigator:	Yeşim Eralp, Assoc.Prof.	Istanbul University Istanbul Medical Faculty, Oncology Institute, Medical Oncology Department, Capa 34360 Istanbul, Turkey
Principal Investigator:	Gül Başaran, Assoc.Prof.	Marmara University Medical Faculty, Medical Oncology Department, Istanbul, Turkey
Principal Investigator:	Kadri Altundağ, Prof.	Hacettepe University Medical Faculty, Medical Oncology Department, Sihhiye 06100 Ankara, Turkey
Principal Investigator:	Filiz Çay Şenler, Assoc.Prof.	Ankara University Medical Faculty, Medical Oncology Department, Sihhiye 06100 Ankara, Turkey
Principal Investigator:	Özlem Er, Assoc.Prof.	Erciyes University Medical Faculty, Medical Oncology Department, 38039 Kayseri, Turkey

More Information

Publications:

Ataya K, Rao LV, Lawrence E, Kimmel R. Luteinizing hormone-releasing hormone agonist inhibits cyclophosphamide-induced ovarian follicular depletion in rhesus monkeys. Biol Reprod. 1995 Feb;52(2):365-72.

Ataya KM, McKanna JA, Weintraub AM, Clark MR, LeMaire WJ. A luteinizing hormone-releasing hormone agonist for the prevention of chemotherapy-induced ovarian follicular loss in rats. Cancer Res. 1985 Aug;45(8):3651-6.

Bines J, Oleske DM, Cobleigh MA. Ovarian function in premenopausal women treated with adjuvant chemotherapy for breast cancer. J Clin Oncol. 1996 May;14(5):1718-29. Review.

Blumenfeld Z, Eckman A. Preservation of fertility and ovarian function and minimization of chemotherapy-induced gonadotoxicity in young women by GnRH-a. J Natl Cancer Inst Monogr. 2005;(34):40-3.

Bokser L, Szende B, Schally AV. Protective effects of D-Trp6-luteinising hormone-releasing hormone microcapsules against cyclophosphamide-induced gonadotoxicity in female rats. Br J Cancer. 1990 Jun;61(6):861-5.

Brincker H, Rose C, Rank F, Mouridsen HT, Jakobsen A, Dombernowsky P, Panduro J, Andersen KW. Evidence of a castration-mediated effect of adjuvant cytotoxic chemotherapy in premenopausal breast cancer. J Clin Oncol. 1987 Nov;5(11):1771-8.

Cheer SM, Plosker GL, Simpson D, Wagstaff AJ. Goserelin: a review of its use in the treatment of early breast cancer in premenopausal and perimenopausal women. Drugs. 2005;65(18):2639-55. Review.

Del Mastro L, Catzeddu T, Boni L, Bell C, Sertoli MR, Bighin C, Clavarezza M, Testa D, Venturini M. Prevention of chemotherapy-induced menopause by temporary ovarian suppression with goserelin in young, early breast cancer patients. Ann Oncol. 2006 Jan;17(1):74-8. Epub 2005 Oct 27.

Del Mastro L, Venturini M, Sertoli MR, Rosso R. Amenorrhea induced by adjuvant chemotherapy in early breast cancer patients: prognostic role and clinical implications. Breast Cancer Res Treat. 1997 Apr;43(2):183-90. Review.

[No authors listed] Polychemotherapy for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998 Sep 19;352(9132):930-42.

Responsible Party:	AstraZeneca Pharmaceuticals ( MC MD )
Study ID Numbers:	D8664L00012
Study First Received:	April 23, 2009
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00888082 History of Changes
Health Authority:	Turkey: Ministry of Health; Turkey: Ethics Committee

Keywords provided by AstraZeneca:

adjuvant chemotherapy
breast cancer
goserelin acetate

ovarian function
Chemotherapy
Primary invasive breast cancer

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Skin Diseases
Adjuvants, Immunologic

Goserelin
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Skin Diseases
Antineoplastic Agents

Therapeutic Uses
Goserelin
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009