Neoplasms

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Breast Neoplasms

Drug-Related Side Effects and Adverse Reactions

Breast Diseases

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Chemically-Induced Disorders

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Hormones

Triptorelin Pamoate

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Antineoplastic Agents, Hormonal

GnRH analogue (triptorelin) during chemotherapy

No GnRH analogue (triptorelin) during chemotherapy

3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection

triptorelin

Pamela N. Munster, MD

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.

OBJECTIVES:

Primary

* Determine the protective effect of chemical ovarian suppression using triptorelin on the preservation of ovarian function in premenopausal women with early-stage operable breast cancer undergoing adjuvant or neoadjuvant systemic chemotherapy.

Secondary

* Determine the rate of chemotherapy-related amenorrhea in patients treated with this drug.
* Determine the value of inhibin A and B as alternative markers of premature ovarian failure in patients treated with this drug.
* Determine quality of life of patients treated with this drug.
* Determine disease-free and overall survival of patients treated with this drug.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (\< 35 years vs 35 to 39 years vs \> 39 years); concurrent neoadjuvant or adjuvant systemic chemotherapy (fluorouracil, epirubicin, and cyclophosphamide \[6 courses\] OR fluorouracil, doxorubicin, and cyclophosphamide \[6 courses\] vs doxorubicin and cyclophosphamide \[AC\] \[4 courses\] vs doxorubicin and cyclophosphamide \[AC\] \[4 courses\] followed by a taxane \[4 courses\]); and hormone receptor status (estrogen receptor \[ER\]- AND progesterone receptor \[PR\]-negative vs ER- OR PR-positive).

* Arm I: Beginning within 1-4 weeks before the start of chemotherapy, patients receive triptorelin intramuscularly once monthly for 4-6 months during neoadjuvant or adjuvant systemic chemotherapy.
* Arm II: Patients receive neoadjuvant or adjuvant systemic chemotherapy only. Quality of life is assessed at baseline, monthly during treatment, every 6 months for 2 years, and then annually for 3 years.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 138 patients (69 per treatment arm) will be accrued for this study within 35 months.

Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer

Preservation of Ovarian Function in Young Women Treated With (Neo) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the Gonadotropin-releasing Hormone (GnRH) Agonist (Triptorelin) During Chemotherapy

Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses every 6 months beginning in month 6 for 2 years and then annually for 3 years

Chemotherapy-related amenorrhea as assessed by record of menses monthly during treatment. Record of menses is completed by patient throughout their time on study through chemotherapy and for 5 years.

National Cancer Institute (NCI)

University of South Florida

GnRH analogue (triptorelin) during chemotherapy

triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection

Triptorelin

no Triptorelin

no GnRH analogue (triptorelin) during chemotherapy

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study closed to accrual early due to futility

Pamela Munster, MD

Time to Resumption of Menses

GnRH analogue (triptorelin) during chemotherapy

triptorelin: 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection

Chemotherapy-related Amenorrhea

Gonadotropin-releasing hormone \[GnRH\] analogue (triptorelin) during chemotherapy

triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection

No Gonadotropin-releasing hormone \[GnRH\] analogue (triptorelin) during chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer	NCT00090844	Breast Cancer Hormone Changes Drug Toxicity	triptorelin	- 44 Years	University of South Florida
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer	NCT00090844	Breast Cancer Hormone Changes Drug Toxicity	triptorelin	- 44 Years	University of South Florida

Spots Global Cancer Trial Database for hormone changes