Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00090844 |
Recruitment Status
:
Terminated
(Early closure due to low accrual)
First Posted
: September 8, 2004
Results First Posted
: January 21, 2013
Last Update Posted
: January 31, 2013
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Hormone Changes Drug Toxicity | Drug: triptorelin | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | 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 |
Study Start Date : | July 2004 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | May 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: triptorelin
GnRH analogue (triptorelin) during chemotherapy
|
Drug: triptorelin
3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
Other Name: Trelstar Depot
|
No Intervention: no triptorelin
No GnRH analogue (triptorelin) during chemotherapy
|
- Time to Resumption of Menses [ Time Frame: Baseline, end of chemotherapy then 5 years ]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 [ Time Frame: Baseline, end of chemotherapy then 5 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.
- Alternative Markers of Ovarian Failure as Assessed by Inhibin A and Inhibin B Every 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years [ Time Frame: Baseline, end of chemotherapy then 5 years ]Inhibin A & inhibin B are collected at baseline, end of chemotherapy, then every 6 months for 2 years then annually for 3 more years. Inhibin A & Inhibin B are markers of ovarian failure.
- Quality of Life as Assessed by FACT-ES Monthly During Treatment, Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years [ Time Frame: Baseline, through chemotherapy then 5 years ]FACT-ES (v4/4a) quality of life validated tool combines 18 item endocrine subscale (ES) with standardized breast cancer quality of life measure. Administered monthly during treatment, every very 6 months beginning in month 6 for 2 years and then annually for 3 years.
- Disease-free Survival Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years [ Time Frame: 5 years after end of chemotherapy ]Every 6 months for 2 years then annual for 3 more years. Patients will be seen, laboratory specimens will be drawn. Menses records will be collected and reviewed. Concomitant medications will be updated.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 44 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090844
United States, California | |
CCOP - Bay Area Tumor Institute | |
Oakland, California, United States, 94609-3305 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 | |
United States, Georgia | |
MBCCOP - Medical College of Georgia Cancer Center | |
Augusta, Georgia, United States, 30912-4000 | |
United States, Illinois | |
MBCCOP - JHS Hospital of Cook County | |
Chicago, Illinois, United States, 60612 | |
United States, Missouri | |
CCOP - Cancer Research for the Ozarks | |
Springfield, Missouri, United States, 65807 | |
Hulston Cancer Center at Cox Medical Center South | |
Springfield, Missouri, United States, 65807 | |
United States, North Dakota | |
CCOP - MeritCare Hospital | |
Fargo, North Dakota, United States, 58122 | |
United States, Texas | |
CCOP - Scott and White Hospital | |
Temple, Texas, United States, 76508 | |
United States, Washington | |
CCOP - Northwest | |
Tacoma, Washington, United States, 98405-0986 |
Study Chair: | Pamela N. Munster, MD | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | University of South Florida |
ClinicalTrials.gov Identifier: | NCT00090844 History of Changes |
Other Study ID Numbers: |
CDR0000374991 P30CA076292 ( U.S. NIH Grant/Contract ) MCC-0203 ( Other Identifier: Moffitt CCOP Research Base ) NCI-7031 ( Other Identifier: National Cancer Institute Division of Cancer Prevention ) |
First Posted: | September 8, 2004 Key Record Dates |
Results First Posted: | January 21, 2013 |
Last Update Posted: | January 31, 2013 |
Last Verified: | January 2013 |
Keywords provided by University of South Florida:
drug/agent toxicity by tissue/organ hormone changes stage I breast cancer stage II breast cancer |
Additional relevant MeSH terms:
Breast Neoplasms Drug-Related Side Effects and Adverse Reactions Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Chemically-Induced Disorders Triptorelin Pamoate |
Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |