Breast CancerPhase 2NCT00090844
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
A Phase 2 study testing triptorelin in people with Breast Cancer and Hormone Changes, run by University of South Florida at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 44 years, women only
- Conditions the study is for
- Breast Cancer, Hormone Changes, Drug Toxicity
- What is being tested?
- triptorelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2004to May 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
Show all 58Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- Other cancer besides nonmelanoma skin cancer
- Prior chemotherapy
- Prior ovarian radiotherapy
- Prior bilateral oophorectomy
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, 30912-4000
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, 60612
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
CCOP - Northwest
Tacoma, Washington, 98405-0986
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497
CCOP - Scott and White Hospital
Temple, Texas, 76508
About this study
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
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Hormone Changes, Drug Toxicity
- Being tested
- triptorelin
- Keywords
- drug/agent toxicity by tissue/organ, hormone changes, stage I breast cancer, stage II breast cancer
- Medical subject headings
- Breast Neoplasms, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triptorelinDrug
Also called Trelstar Depot
3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| triptorelin | Experimental | GnRH analogue (triptorelin) during chemotherapy Receives: Drug: triptorelin |
| no triptorelin | No intervention | No GnRH analogue (triptorelin) during chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Resumption of Menses
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
Measured: Baseline, end of chemotherapy then 5 years
Secondary outcomes (1)
Chemotherapy-related Amenorrhea
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.
Measured: Baseline, end of chemotherapy then 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2004 (estimated)
- Study startJul 2004
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: Early closure due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Pamela N. Munster, MD, Study chair, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090844
- Sponsor's protocol ID
- CDR0000374991
- Other IDs
- P30CA076292, MCC-0203, NCI-7031
- Status last verified
- Jan 2013
- First submitted
- 7 Sep 2004
- Last updated
- 28 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00090844
- Acronym / sponsor ID
- CDR0000374991
- Conditions
- Breast Cancer, Hormone Changes, Drug Toxicity
- Keywords
- drug/agent toxicity by tissue/organ, hormone changes, stage I breast cancer, stage II breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early closure due to low accrual
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 8 Sep 2004 (estimated)
- Results
- Posted 21 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triptorelin | Experimental | Drug: triptorelinGnRH analogue (triptorelin) during chemotherapy |
| no triptorelin | No intervention | –No GnRH analogue (triptorelin) during chemotherapy |
Who may qualify
- Ages
- Up to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (58 listed)
- Histologically confirmed breast cancer
- Scheduled to receive adjuvant or neoadjuvant systemic chemotherapy for breast cancer
- Hormone receptor status:
- No history of premature ovarian failure
- Age
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| triptorelinAlso: Trelstar Depot3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection | Drug | triptorelin |
Primary outcome
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
1 secondary outcome
Chemotherapy-related Amenorrhea
Time frame: Baseline, end of chemotherapy then 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Published ResultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela N. Munster, MD study chair
H. Lee Moffitt Cancer Center and Research Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing triptorelin in people with Breast Cancer and Hormone Changes, run by University of South Florida at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 58 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Resumption of Menses (time frame: Baseline, end of chemotherapy then 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.