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Trial · Interventional

CompletedPhase 2Results postedRegistry data

TRial on the Endocrine Activity of Neoadjuvant Degarelix

Short name TREND

NCTNCT02005887 (opens ClinicalTrials.gov in a new tab)Other idIBCSG 41-13Other id2012-005326-29

Overview

Status
Completed
Phase
Phase 2
Enrollment
51 participants (actual)
Sponsor
ETOP IBCSG Partners Foundation · Network
Design
Randomized · Open label (no masking)
Countries
1 country

Italy

Start
Feb 2014
Primary completion
25 Aug 2017
Completion
25 Aug 2017
First posted
9 Dec 2013 (estimated)
Last update posted
2 Sept 2026
Conditions
Breast Cancer Invasive Nos

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015201620172018
  1. Ph 2

    TREND

    NCT02005887

    Feb 2014 to 25 Aug 2017

Registry summary

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

The purpose of the this study is to investigate the anti-tumor activity and tolerability of the study medications Degarelix and Triptorelin in premenopausal women receiving preoperative treatment with Letrozole.

Interventions

  • triptorelinDrug
  • degarelixDrug
  • letrozoleDrug

Arms2

  • Experimental

    triptorelin + letrozole

    Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles

  • Experimental

    degarelix + letrozole

    Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to Optimal Ovarian Function Suppression

    Time frame · up to 24 weeks

    Registry description

    Time from the first injection of degarelix or triptorelin to the first assessment of centrally assessed 17-β-estradiol (E2) level in the range of optimal ovarian function suppression (≤2.72 pg/mL or ≤10 pmol/L) during the 6 cycles of neoadjuvant treatments.

Secondary outcomes(6)
  1. Ki67 Proliferation Marker Changes

    Time frame · Before day1 of cycle 1 and surgery

    Registry description

    The percent change in Ki67 expression from pre-treatment diagnostic (baseline) biopsy to surgery, calculated as (surgery-baseline)/baseline\*100.

  2. Preoperative Endocrine Prognostic Index (PEPI) Score

    Time frame · After 24 weeks or the time of surgery

    Registry description

    Preoperative Endocrine Prognostic Index (PEPI) is the sum of the risk points (tumor size, nodal status, Ki67 level, ER status) with a 0-12 score representing the best prognostic feature (0 being the best score; 12 being the worst score), as previously determined to be associated with recurrence-free survival.

  3. Best Overall (Disease) Response

    Time frame · From day 1 of cycle 1 across all time points until disease progression

    Registry description

    Based on WHO tumor measurement and response criteria \[1\], measured from the start of treatment across all time points until disease progression or the end of 6 cycles of neoadjuvant therapies, whichever comes first. Response was determined by the IBCSG Head of Medical Affairs. An internal review (IR) form was created to record the final determination on best overall response. Confirmation of partial or complete response by an additional scan was not required in this trial. Best overall response was assessed based on changes in tumor size from baseline to the assessments after 3 and after 6 cycles (denoted as day 1 of cycle 4 and prior to surgery respectively) as measured physically by caliper or ruler and as measured by breast tumor imaging (i.e., bilateral mammography and breast ultrasound).

  4. Percentage of Patients With Node-negative Disease at Surgery

    Time frame · During surgery, an average of 2 hours

    Registry description

    The number of lymph nodes assessed at surgery minus the number of positives nodes identified, equal to zero.

  5. Percentage of Patients Who Underwent Breast-Conserving Surgery (BCS)

    Time frame · During surgery, an average of 2 hours

    Registry description

    Whether or not patient undergoes BCS (per Surgery form).

  6. Patient-reported Symptoms (PRS) Outcomes

    Time frame · At baseline, day 1 of cycle 2 and cycle 4 and prior to surgery; cycle 4 reported

    Registry description

    The patient-reported symptoms (PRS) will be assessed using the Functional Assessment of Cancer Therapy Endocrine Subscale (FACT-ES) comprising 18 items (each has score range from 0 to 4) with a possible minimum total score of 0 and maximum total score of 72 (72 is best). Functional Assessment of Chronic Illness Therapy (FACIT) guidelines will be used for scoring and interpretation of the FACT-ES total score.

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· up to 24 weeks

Time to Optimal Ovarian Function Suppression

GroupValue (days)
Arm A: Triptorelin + Letrozol14
Arm B: Degarelix + Letrozol3
Secondary and other outcome results(6)
Secondary outcomeMedian· Before day1 of cycle 1 and surgery

Ki67 Proliferation Marker Changes

GroupValue (percentage change)
Arm A: Triptorelin + Letrozol-10.0
Arm B: Degarelix + Letrozol-8.0
Secondary outcomeMedian· After 24 weeks or the time of surgery

Preoperative Endocrine Prognostic Index (PEPI) Score

GroupValue (scores on a scale)
Arm A: Triptorelin + Letrozol6.5
Arm B: Degarelix + Letrozol6.0
Secondary outcomeNumber· From day 1 of cycle 1 across all time points until disease progression

Best Overall (Disease) Response

GroupValue (percentage of patients)
Arm A: Triptorelin + Letrozol46.2
Arm B: Degarelix + Letrozol44.0
Secondary outcomeNumber· During surgery, an average of 2 hours

Percentage of Patients With Node-negative Disease at Surgery

GroupValue (percentage of patients)
Arm A: Triptorelin + Letrozol34.6
Arm B: Degarelix + Letrozol43.5
Secondary outcomeNumber· During surgery, an average of 2 hours

Percentage of Patients Who Underwent Breast-Conserving Surgery (BCS)

GroupValue (percentage of patients)
Arm A: Triptorelin + Letrozol42.3
Arm B: Degarelix + Letrozol52.2
Secondary outcomeNumber· At baseline, day 1 of cycle 2 and cycle 4 and prior to surgery; cycle 4 reported

Patient-reported Symptoms (PRS) Outcomes

GroupValue (units on a scale)
Arm A: Triptorelin + Letrozol64
Arm B: Degarelix + Letrozol62

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Arm A: Triptorelin + LetrozolArm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days) Letrozole: Letrozole 2.5 mg orally every day for 6 cycles0 / 260 / 2623 / 26
Arm B: Degarelix + LetrozolArm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days) Letrozole: Letrozole 2.5 mg orally every day for 6 cycles0 / 250 / 2523 / 25

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

5 results

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

Dellapasqua et al. 2019Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 23

PMID 30589600DOI 10.1200/jco.18.00296PUB-30589600

Full text at the publisher5 results

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Female gender * Premenopausal status measured within 14 days Prior to randomization: Estradiol (E2) must be above 54 pg/mL (or above 198 pmol/L * Age ≥ 18 years * Performance Status - Eastern Cooperative Oncology Group (ECOG) 0-1 * Histologically confirmed invasive breast cancer: Primary tumor greater than 2 cm Diameter, any nodal stage, no evidence of metastasis (M0) * Primary tumor must have ER and PgR \>50% of the cells * Primary tumor must be HER2-negative (by IHC and/or ISH) * Hematopoietic status: Absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 9 g/dL * Hepatic status: Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), AST and ALT ≤ 2.5 × ULN, Alkaline phosphatase ≤ 2.5 × ULN * Renal status: Creatinine ≤ 1.5 ×ULN * Negative serum pregnancy test, within 2 weeks (preferably 7 days) prior to randomization. * The patient must be willing to use effective non-hormonal contraception after the pregnancy test and up to surgery. Oral, injectable, or implant hormonal contraceptives or medicated IUD are not allowed within 2 months prior to randomization and during the trial. * Prior fertility treatment is allowed but must have been stopped at least 12 months before randomization. * The patient has completed the baseline patient-reported symptoms questionnaire. * Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization. * The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines. * The patient accepts blood samples to be taken for the determination of the primary endpoint. * The patient agrees to make tumor available for submission for central pathology review and for translational studies as part of this protocol Exclusion Criteria: * Postmenopausal * Any hormonal treatment (e.g., oral, injectable, implant, or medicated IUD) in the previous 2 months * Presence of HER2 overexpression or amplification * Received any prior treatment for primary invasive breast cancer * Received any GnRH analog or SERM or AI within 12 months prior to randomization * A history of malignant neoplasms within the past 10 years, except for curatively treated,Basal and squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the bladder * Previous ipsilateral breast cancer (invasive or in situ) at any time * Inflammatory breast cancer * Bilateral invasive breast cancer * Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen * Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety * Unresolved or unstable, serious adverse events from prior administration of another investigational drug * Active or uncontrolled infection CTCAE v.4 grade 2 or higher * Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of Informed Consent * Treatment with an investigational agent must have stopped at least 30 days before randomization. * Pregnant or lactating women; lactation has to stop before randomization.

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