Trial · NCT07159451
A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer
NCT07159451, Phase 2, Recruiting, Gustave Roussy, Cancer Campus, Grand Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer. Trials, record NCT07159451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07159451
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer
- NCT number
- NCT07159451
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 140 participants, estimated
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Conditions
- Breast Cancer
- Interventions
- Elacestrant, Leuprorelin
- First posted
- 2025-09-08
- Last updated
- 2025-12-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To determine if 4 weeks of elacestrant monotherapy determines a non-inferior anti-proliferative effect, measured by Ki67, in comparison to elacestrant with leuprorelin in premenopausal patients with ER-positive/HER2- operable invasive BC. | Surgery | |
| Secondary | Complete cell cycle arrest (CCCA) measured by Ki67 <2.7% | Surgery | |
| Secondary | Objective Response Rate | From baseline to day 29 | partial and complete response obtained as measured by MRI |
| Secondary | Rate of pathological of partial and complete response | at surgery | |
| Secondary | Levels of estradiol | at baseline, Day 14, and Day 28 then postoperatively at 1 month | |
| Secondary | Levels of follicle-stimulating hormone (FSH) | at baseline, Day 14, and Day 28 then postoperatively at 1 month | |
| Secondary | Levels of luteinizing hormone (LH) | at baseline, Day 14, and Day 28 then postoperatively at 1 month | |
| Secondary | Incidence of treatment-emergent AEs | From enrollment until 28 days post surgery | assessed by the national cancer institute (NCI) Common Terminology for Classification of Adverse Events (CTCAE) version 5.0, |
| Secondary | Duration of treatment-emergent AEs | From enrollment until 28 days post surgery | assessed by the national cancer institute (NCI) Common Terminology for Classification of Adverse Events (CTCAE) version 5.0, |
| Secondary | Severity of treatment-emergent | From enrollment until 28 days post surgery | AEs assessed by the national cancer institute (NCI) Common Terminology for Classification of Adverse Events (CTCAE) version 5.0 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07159451
GET https://conductscience.org/api/trials/v1/NCT07159451/registered