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Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00888082 |
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 |
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 |
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
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B: Experimental
Patient receiving goserelin acetate along with adjuvant chemotherapy
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Drug: Goserelin acetate
3.6 mg depot injectable preparation
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Turkey Clinical Study Information | +90 212 317 2386 | zeynep.goztas@astrazeneca.com |
Turkey | |
Research Site | Recruiting |
Istanbul, Turkey | |
Research Site | Recruiting |
Ankara, Turkey | |
Research Site | Recruiting |
Kayseri, Turkey |
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 |
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 |
adjuvant chemotherapy breast cancer goserelin acetate |
ovarian function Chemotherapy Primary invasive breast cancer |
Antineoplastic Agents, Hormonal Skin Diseases Adjuvants, Immunologic |
Goserelin Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Skin Diseases Antineoplastic Agents |
Therapeutic Uses Goserelin Breast Neoplasms Pharmacologic Actions Breast Diseases |