Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer, Ovarian Function

Intervention / Treatment
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* Drug: Goserelin acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A<br>Patients receiving only adjuvant chemotherapy | |
| Experimental: B<br>Patient receiving goserelin acetate along with adjuvant chemotherapy | Drug: Goserelin acetate<br>* 3.6 mg depot injectable preparation<br>* Other names: Zoladex 3.6 mg Depot;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | Each 3 months | 
| The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles |  | Each 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QOL) through-out the study measured by FACT-ES scale. |  | Each 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adjuvant chemotherapy, breast cancer, goserelin acetate, ovarian function, Chemotherapy, Primary invasive breast cancer