Clinical trial NCT00888082: 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Breast Cancer
Ovarian Function
Keywords: adjuvant chemotherapy
breast cancer
goserelin acetate
ovarian function
Chemotherapy
Primary invasive breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-24
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Each 3 months
measure: The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles
timeFrame: Each 3 months
Secondary outcomes:
measure: Quality of life (QOL) through-out the study measured by FACT-ES scale.
timeFrame: Each 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
Study officials:
affiliation: Istanbul University Cerrahpasa Medical Faculty, Medical Oncology Clinic, Cerrahpasa 34098, Istanbul, Turkey
name: Mustafa Özgüroğlu, Assoc.Prof.
role: STUDY_CHAIR
affiliation: Istanbul University Istanbul Medical Faculty, Oncology Institute, Medical Oncology Department, Capa 34360 Istanbul, Turkey
name: Yeşim Eralp, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University Medical Faculty, Medical Oncology Department, Istanbul, Turkey
name: Gül Başaran, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University Medical Faculty, Medical Oncology Department, Sihhiye 06100 Ankara, Turkey
name: Kadri Altundağ, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University Medical Faculty, Medical Oncology Department, Sihhiye 06100 Ankara, Turkey
name: Filiz Çay Şenler, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Erciyes University Medical Faculty, Medical Oncology Department, 38039 Kayseri, Turkey
name: Metin Özkan
role: PRINCIPAL_INVESTIGATOR
References:
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