Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
Condition: Breast Cancer; Hormone Changes; Drug Toxicity
MeSH terms: Breast Neoplasms; Drug-Related Side Effects and Adverse Reactions
Intervention: triptorelin
Intervention description: 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: Female
Maximum age: 44 Years
Healthy volunteers: No
Keywords: drug/agent toxicity by tissue/organ; hormone changes; stage I breast cancer; stage II breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
      dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect
      normal ovarian cells from the side effects of chemotherapy.

      PURPOSE: This randomized phase II trial is studying how well triptorelin works in preserving
      ovarian function in premenopausal women who are receiving chemotherapy for early-stage breast
      cancer.
    

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