Spots Global Cancer Trial Database for Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy
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Trial Identification
Brief Title: Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy
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
Study ID: NCT00888082
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Research Site, Ankara, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Kayseri, , Turkey
Contact Details
Name: Mustafa Özgüroğlu, Assoc.Prof.
Affiliation: Istanbul University Cerrahpasa Medical Faculty, Medical Oncology Clinic, Cerrahpasa 34098, Istanbul, Turkey
Role: STUDY_CHAIR
Name: Yeşim Eralp, Assoc.Prof.
Affiliation: Istanbul University Istanbul Medical Faculty, Oncology Institute, Medical Oncology Department, Capa 34360 Istanbul, Turkey
Role: PRINCIPAL_INVESTIGATOR
Name: Gül Başaran, Assoc.Prof.
Affiliation: Marmara University Medical Faculty, Medical Oncology Department, Istanbul, Turkey
Role: PRINCIPAL_INVESTIGATOR
Name: Kadri Altundağ, Prof.
Affiliation: Hacettepe University Medical Faculty, Medical Oncology Department, Sihhiye 06100 Ankara, Turkey
Role: PRINCIPAL_INVESTIGATOR
Name: Filiz Çay Şenler, Assoc.Prof.
Affiliation: Ankara University Medical Faculty, Medical Oncology Department, Sihhiye 06100 Ankara, Turkey
Role: PRINCIPAL_INVESTIGATOR
Name: Metin Özkan
Affiliation: Erciyes University Medical Faculty, Medical Oncology Department, 38039 Kayseri, Turkey
Role: PRINCIPAL_INVESTIGATOR
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