Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT00090844Other idCDR0000374991Other idP30CA076292Other idMCC-0203Other idNCI-7031

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Early closure due to low accrual

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 49 participants (actual)
Sponsor: University of South Florida · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jul 2004
Primary completion: May 2008
Completion: May 2008
First posted: 8 Sept 2004 (estimated)
Last update posted: 28 Jan 2021
Conditions: Breast Cancer · Hormone Changes · Drug Toxicity

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200420052006200720082009

Ph 2
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
NCT00090844
Jul 2004 to May 2008
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

triptorelinDrug

Arms2

Experimental
triptorelin
GnRH analogue (triptorelin) during chemotherapy
No intervention
no triptorelin
No GnRH analogue (triptorelin) during chemotherapy

Primary outcomes1

Outcomes the sponsor listed as primary.

Time to Resumption of Menses
Time frame · Baseline, end of chemotherapy then 5 years
Registry description
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

Secondary outcomes(1)

Chemotherapy-related Amenorrhea
Time frame · Baseline, end of chemotherapy then 5 years
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Baseline, end of chemotherapy then 5 years

Time to Resumption of Menses

Group	Value (months)
Triptorelin	4.96
no Triptorelin	5.82

Secondary and other outcome results(1)

Secondary outcomeCount of participants· Baseline, end of chemotherapy then 5 years

Chemotherapy-related Amenorrhea

Group	Value (Participants)
Triptorelin	3
no Triptorelin	2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
TriptorelinGnRH analogue (triptorelin) during chemotherapy triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection	–	2 / 27	25 / 27
no TriptorelinNo GnRH analogue (triptorelin) during chemotherapy	–	0 / 22	18 / 22

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: up to 44 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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