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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


Phase 3
18 Years
45 Years
Not Enrolling
Female
Breast Cancer, Ovarian Function

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome 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)

Outcome Time Frame:

Each 3 months

Safety Issue:

No

Principal Investigator

Mustafa Özgüroğlu, Assoc.Prof.

Investigator Role:

Study Chair

Investigator Affiliation:

Istanbul University Cerrahpasa Medical Faculty, Medical Oncology Clinic, Cerrahpasa 34098, Istanbul, Turkey

Authority:

Turkey: Ministry of Health

Study ID:

D8664L00012

NCT ID:

NCT00888082

Start Date:

Completion Date:

April 2012

Related Keywords:

  • Breast Cancer
  • Ovarian Function
  • adjuvant chemotherapy
  • breast cancer
  • goserelin acetate
  • ovarian function
  • Chemotherapy
  • Primary invasive breast cancer
  • Breast Neoplasms

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