Clinical trial NCT00090844 (phase 2, status: terminated)
Conditions: breast cancer, hormone changes, drug toxicity
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: triptorelin
SMILES: CC(C)C[C@H](NC(=O)[C@@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=C1C=CC=C2)NC(=O)[C@H](CC1=CNC=N1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1CCC[C@H]1C(=O)NCC(N)=O
Reason stopped: 
    early closure due to low accrual
  
Eligibility criteria:

        Inclusion Criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed breast cancer

               -  Early-stage, operable disease

          -  Scheduled to receive adjuvant or neoadjuvant systemic chemotherapy for breast cancer

          -  Hormone receptor status:

               -  Meets 1 of the following criteria:

                    -  Estrogen receptor (ER)- OR progesterone receptor (PR)-positive

                    -  ER- AND PR-negative

          -  No history of premature ovarian failure

        PATIENT CHARACTERISTICS:

        Age

          -  Under 45

        Sex

          -  Female

        Menopausal status

          -  Premenopausal

               -  Follicle-stimulating hormone levels < 40 IU/L at baseline AND at least 2
                  menstrual periods within the past 6 months

          -  No first-degree relative menopausal at < 40 years of age

        Performance status

          -  Eastern Cooperative Oncology Group [ECOG] 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective non-hormonal methods of contraception

          -  No prior osteoporosis or other non-malignant systemic disease that would preclude
             prolonged follow-up

          -  No known allergies to gonadotrophin-releasing hormone agonists

          -  No other cancer except nonmelanoma skin cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  See Disease Characteristics

          -  No prior chemotherapy

        Endocrine therapy

          -  At least 2 weeks since prior oral contraceptives

          -  No prior fertility treatment

               -  Clomiphene or pergonal for polycystic ovarian disease allowed

          -  No other concurrent oral or transdermal hormonal therapy, including any of the
             following:

               -  Estrogen

               -  Progesterone

               -  Androgens

               -  Aromatase inhibitors

               -  Hormone replacement therapy

               -  Oral contraceptives

        Radiotherapy

          -  No prior ovarian radiotherapy

        Surgery

          -  No prior bilateral oophorectomy

          -  No plans for oophorectomy or hysterectomy within the next 2 years

        Other

          -  At least 1 week since prior warfarin

        Exclusion Criteria:

          -  History of premature ovarian failure

          -  Over 45 years of age

          -  First-degree relative menopausal at < 40 years of age

          -  Pregnant or nursing

          -  Prior osteoporosis or other non-malignant systemic disease that would preclude
             prolonged follow-up

          -  Known allergies to gonadotrophin-releasing hormone agonists

          -  Other cancer besides nonmelanoma skin cancer

          -  Prior chemotherapy

          -  Prior ovarian radiotherapy

          -  Prior bilateral oophorectomy