S0230 Goserelina para prevenir la insuficiencia ovarica en mujeres que reciben quimioterapia para el cancer de mama

Not Applicable

• Conditions: -E288 Other ovarian dysfunction; Other ovarian dysfunction; E288

• Registration Number: PER-014-06
• Lead Sponsor: EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-25
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients must be menopausal women with histologically confirmed diagnosis of Operable Invasive Breast Cancer stage I, II or IIA.
2. Patients should have tumors with hormone receptors positive for estrogen and progesterone.
3. Patients must be 18 to 50 years of age.
4. The treatment plan for patients is 3 to 8 months of standard chemotherapy with anthracycline or non-anthracycline agents as adjuvants or neoadjuvants.
5. Patients receiving chemotherapy in the preoperative stage should have planned to receive additional chemotherapy in the postoperative stage.
6. Patients receiving post-surgical chemotherapy should register before 84 days after the final surgery required for the proper treatment of the primary tumor.
7. Patients recruited in S0221 are eligible for this study.
8. Patients must have a physical status of 0 to 2 by Zubrod criteria.
9. All patients must be informed about the research nature of this study and must sign and give their consent.

Exclusion Criteria

1. Patients must not have received chemotherapy for breast cancer or for any condition.
2. Patients must not have received estrogen or antiestrogens in the last 3 months. selective modulators of estrogen receptors, aromatase inhibitors or another hormonal form of contraception.
3. They must not have previous malignancy.
4. Women who are pregnant or breastfeeding can not participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical history and physical examination. FSH, estradiol and inhibin B.<br><br>Measure:Premature ovarian failure rate after 2 years of treatment: Fertility evaluation and Ovarian function evaluation.<br><br>Timepoints:Physical examination: during each visit during the treatment-<br>FSH, estradiol and inhibin B: Days 2, 3 or 4 of the menstrual cycles of months 12 or 13 and 24 or 25 in women with regular catamenial regimen, and at some time during months 12 or 13 and 24 or 25 in women amenorrheic.<br>;<br>Outcome name:Clinical history and physical examination. FSH.<br>Measure:Premature ovarian failure rate after 2 years of treatment: Amenorrhea for 6 months and presence of FSH in the post-menopausal range.<br>Timepoints:Physical exam: during each visit during the treatment.<br>FSH: Days 2, 3 or 4 of the menstrual cycles of months 12 or 13 and 24 or 25 in women with regular catamenial regimen, and at some time during months 12 or 13 and 24 or 25 in amenorrheic women.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:FSH, estradiol and inhibin B in peripheral blood.<br>Measure:Rates of ovarian dysfunction at 1 year and 2 years after therapy. Ovarian dysfunction is defined as: Amenorrhea for 3 months plus FSH, estradiol and inhibin B in post-menopausal ranges.<br><br>Timepoints:FSH, estradiol and inhibin B: Days 2, 3 or 4 of the menstrual cycles of months 12 or 13 and 24 or 25 in women with regular catamenial regimen, and at some time during months 12 or 13 and 24 or 25 in women amenorrheic.<br>