Neoadjuvant Degarelix Versus Triptorelin in Premenopausal Patients Who Receive Letrozole for Locally Advanced Endocrine-Responsive Breast Cancer: A Randomized Phase II Trial.

Dellapasqua S, Gray KP, Munzone E, Rubino D, Gianni L, Johansson H, Viale G, Ribi K, Bernhard J, Kammler R, Maibach R, Rabaglio-Poretti M and 7 more

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Ruepp B, Di Leo A, Coates AS, Gelber RD, Regan MM, Goldhirsch A, Colleoni M

Journal of clinical oncology : official journal of the American Society of Clinical Oncology27 Dec 2018Cited by 23 (Europe PMC)

PMID30589600DOI10.1200/jco.18.00296PepBankPUB-30589600

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In premenopausal women with breast cancer receiving letrozole, optimal ovarian suppression took longer with triptorelin than with degarelix.
In plain wordsIn premenopausal women with breast cancer receiving letrozole, ovarian suppression took longer with triptorelin than with degarelix.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
IncreaseTime to optimal ovarian function suppression
Study
n = 51
Comparator
degarelix with the same letrozole background
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
3.75 mg on day 1 of every cycle · intramuscular · six 28-day cyclesAs given in this study (human).
Measurements
Median time to optimal OFS
14 days
triptorelin plus letrozole
Median time to optimal OFS
3 days
degarelix plus letrozole
Hazard ratio for time to optimal OFS
3.05 hazard ratio
degarelix plus letrozole versus triptorelin plus letrozole
Source sentences
Summary
Time to optimal OFS was three times faster for patients assigned to degarelix and letrozole than to triptorelin and letrozole (median, 3 v 14 days; hazard ratio, 3.05; 95% CI, 1.65 to 5.65; P < .001).
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate endocrine activity in terms of ovarian function suppression (OFS) of degarelix (a gonadotropin-releasing hormone [GnRH] antagonist) versus triptorelin (a GnRH agonist) in premenopausal patients receiving letrozole as neoadjuvant endocrine therapy for breast cancer.
Summary · context
Between February 2014 and January 2017, 51 patients were enrolled (n = 26 received triptorelin plus letrozole; n = 25 received degarelix plus letrozole).
Report a problemFND-3058960001
02HumanRandomized controlled trialEfficacy outcome
In premenopausal breast cancer patients receiving letrozole, degarelix shortened median time to optimal ovarian suppression versus triptorelin (3 versus 14 days).
In plain wordsIn premenopausal breast cancer patients receiving letrozole, degarelix achieved optimal ovarian suppression faster than triptorelin.
Peptide
Degarelix
Outcome
DecreaseTime to optimal ovarian function suppression
Study
n = 51
Comparator
Triptorelin plus letrozole
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240 mg on day 1 of cycle 1, then 80 mg on day 1 of cycles 2 through 6 · subcutaneousAs given in this study (human).
Measurements
Median time to optimal OFS
3 days
degarelix plus letrozole
Median time to optimal OFS
14 days
triptorelin plus letrozole
Hazard ratio
3.05
degarelix plus letrozole versus triptorelin plus letrozole
95% CI lower bound
1.65
hazard ratio
95% CI upper bound
5.65
hazard ratio
P value
< 0.001
between-group comparison
Source sentences
Summary
Time to optimal OFS was three times faster for patients assigned to degarelix and letrozole than to triptorelin and letrozole (median, 3 v 14 days; hazard ratio, 3.05; 95% CI, 1.65 to 5.65; P < .001).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary end point was time to optimal OFS (time from the first injection to first assessment of centrally assessed estradiol level ≤ 2.72 pg/mL [≤ 10 pmol/L] during neoadjuvant therapy).
Summary · context
To evaluate endocrine activity in terms of ovarian function suppression (OFS) of degarelix (a gonadotropin-releasing hormone [GnRH] antagonist) versus triptorelin (a GnRH agonist) in premenopausal patients receiving letrozole as neoadjuvant endocrine therapy for breast cancer.
Summary · context
Between February 2014 and January 2017, 51 patients were enrolled (n = 26 received triptorelin plus letrozole; n = 25 received degarelix plus letrozole).
Report a problemFND-3058960004
03HumanRandomized controlled trialEfficacy outcome
In premenopausal women with breast cancer receiving letrozole, suboptimal ovarian suppression occurred with triptorelin while degarelix maintained suppression in all patients.
In plain wordsIn premenopausal women with breast cancer receiving letrozole, some triptorelin patients had incomplete ovarian suppression, while all degarelix patients maintained suppression.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
IncreaseSuboptimal ovarian function suppression after cycle 1
Study
n = 51
Comparator
degarelix with the same letrozole background
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
3.75 mg on day 1 of every cycle · intramuscular · six 28-day cyclesAs given in this study (human).
Measurements
Patients with suboptimal OFS
15.4%
triptorelin plus letrozole after cycle 1
Suboptimal OFS events
6 events
127 measurements
Source sentences
Summary
Furthermore, OFS was maintained during subsequent cycles for all patients assigned to receive degarelix and letrozole, whereas 15.4% of patients assigned to receive triptorelin and letrozole had suboptimal OFS after cycle 1 (six events during 127 measurements).
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate endocrine activity in terms of ovarian function suppression (OFS) of degarelix (a gonadotropin-releasing hormone [GnRH] antagonist) versus triptorelin (a GnRH agonist) in premenopausal patients receiving letrozole as neoadjuvant endocrine therapy for breast cancer.
Summary · context
Between February 2014 and January 2017, 51 patients were enrolled (n = 26 received triptorelin plus letrozole; n = 25 received degarelix plus letrozole).
Report a problemFND-3058960002
04HumanRandomized controlled trialEfficacy outcome
In premenopausal breast cancer patients receiving letrozole, degarelix maintained ovarian suppression in all patients, whereas 15.4% with triptorelin had suboptimal suppression after cycle 1.
In plain wordsIn premenopausal breast cancer patients receiving letrozole, all degarelix patients maintained ovarian suppression, whereas some triptorelin patients had suboptimal suppression.
Peptide
Degarelix
Outcome
IncreaseMaintenance of ovarian function suppression
Study
n = 51
Comparator
Triptorelin plus letrozole
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240 mg on day 1 of cycle 1, then 80 mg on day 1 of cycles 2 through 6 · subcutaneousAs given in this study (human).
Measurements
Patients with suboptimal OFS after cycle 1
15.4%
triptorelin plus letrozole
Suboptimal OFS events
6 events
triptorelin plus letrozole, during 127 measurements
Source sentences
Summary
Furthermore, OFS was maintained during subsequent cycles for all patients assigned to receive degarelix and letrozole, whereas 15.4% of patients assigned to receive triptorelin and letrozole had suboptimal OFS after cycle 1 (six events during 127 measurements).
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate endocrine activity in terms of ovarian function suppression (OFS) of degarelix (a gonadotropin-releasing hormone [GnRH] antagonist) versus triptorelin (a GnRH agonist) in premenopausal patients receiving letrozole as neoadjuvant endocrine therapy for breast cancer.
Summary · context
Between February 2014 and January 2017, 51 patients were enrolled (n = 26 received triptorelin plus letrozole; n = 25 received degarelix plus letrozole).
Report a problemFND-3058960005

Studies that did not test the peptide alone1

In this study, Triptorelin (Trelstar, Decapeptyl) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Triptorelin (Trelstar, Decapeptyl).

05HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialSafety outcome
In premenopausal women with breast cancer, adverse events with triptorelin plus letrozole were as expected.
In plain wordsIn premenopausal women with breast cancer, adverse events with triptorelin plus letrozole were as expected.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
Not applicableExpected adverse events
Study
n = 26
Outcome group
Adverse events · Whole body
Source sentences
Summary
Adverse events as a result of both degarelix plus letrozole and triptorelin plus letrozole were as expected.
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate endocrine activity in terms of ovarian function suppression (OFS) of degarelix (a gonadotropin-releasing hormone [GnRH] antagonist) versus triptorelin (a GnRH agonist) in premenopausal patients receiving letrozole as neoadjuvant endocrine therapy for breast cancer.
Summary · context
Between February 2014 and January 2017, 51 patients were enrolled (n = 26 received triptorelin plus letrozole; n = 25 received degarelix plus letrozole).
In this study, Triptorelin (Trelstar, Decapeptyl) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Triptorelin (Trelstar, Decapeptyl).
Report a problemFND-3058960003

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT02005887

TRial on the Endocrine Activity of Neoadjuvant Degarelix

ETOP IBCSG Partners Foundationn = 51Feb 2014 to 25 Aug 2017

Breast Cancer Invasive Nos

Trial page ClinicalTrials.govUpdated 2 Sept 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 3Current
27 Oct 2026, 16:34 UTC
Study data updated · source update from Europe PMC
Version 2
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC