Time to Optimal Ovarian Function Suppression
| Group | Value (days) |
|---|---|
| Arm A: Triptorelin + Letrozol | 14 |
| Arm B: Degarelix + Letrozol | 3 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name TREND
Italy
1 trial · 1 completed · 1 with posted results
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.
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
Outcomes the sponsor listed as primary.
Time to Optimal Ovarian Function Suppression
Time frame · up to 24 weeks
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.
Ki67 Proliferation Marker Changes
Time frame · Before day1 of cycle 1 and surgery
The percent change in Ki67 expression from pre-treatment diagnostic (baseline) biopsy to surgery, calculated as (surgery-baseline)/baseline\*100.
Preoperative Endocrine Prognostic Index (PEPI) Score
Time frame · After 24 weeks or the time of surgery
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.
Best Overall (Disease) Response
Time frame · From day 1 of cycle 1 across all time points until disease progression
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).
Percentage of Patients With Node-negative Disease at Surgery
Time frame · During surgery, an average of 2 hours
The number of lymph nodes assessed at surgery minus the number of positives nodes identified, equal to zero.
Percentage of Patients Who Underwent Breast-Conserving Surgery (BCS)
Time frame · During surgery, an average of 2 hours
Whether or not patient undergoes BCS (per Surgery form).
Patient-reported Symptoms (PRS) Outcomes
Time frame · At baseline, day 1 of cycle 2 and cycle 4 and prior to surgery; cycle 4 reported
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (days) |
|---|---|
| Arm A: Triptorelin + Letrozol | 14 |
| Arm B: Degarelix + Letrozol | 3 |
| Group | Value (percentage change) |
|---|---|
| Arm A: Triptorelin + Letrozol | -10.0 |
| Arm B: Degarelix + Letrozol | -8.0 |
| Group | Value (scores on a scale) |
|---|---|
| Arm A: Triptorelin + Letrozol | 6.5 |
| Arm B: Degarelix + Letrozol | 6.0 |
| Group | Value (percentage of patients) |
|---|---|
| Arm A: Triptorelin + Letrozol | 46.2 |
| Arm B: Degarelix + Letrozol | 44.0 |
| Group | Value (percentage of patients) |
|---|---|
| Arm A: Triptorelin + Letrozol | 34.6 |
| Arm B: Degarelix + Letrozol | 43.5 |
| Group | Value (percentage of patients) |
|---|---|
| Arm A: Triptorelin + Letrozol | 42.3 |
| Arm B: Degarelix + Letrozol | 52.2 |
| Group | Value (units on a scale) |
|---|---|
| Arm A: Triptorelin + Letrozol | 64 |
| Arm B: Degarelix + Letrozol | 62 |
| Group | Deaths | Serious events | Other 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 cycles | 0 / 26 | 0 / 26 | 23 / 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 cycles | 0 / 25 | 0 / 25 | 23 / 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
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2019
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
Who could join, as posted.
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