Trial · NCT06837792
Trastuzumab Deruxtecan vs Endocrine Therapy in Low-HER2 HR+ Advanced Breast Cancer
NCT06837792, Phase 2, Recruiting, Yonsei University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trastuzumab Deruxtecan vs Endocrine Therapy in Low-HER2 HR+ Advanced Breast Cancer. Trials, record NCT06837792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06837792
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trastuzumab Deruxtecan vs Endocrine Therapy in Low-HER2 HR+ Advanced Breast Cancer
- NCT number
- NCT06837792
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 141 participants, estimated
- Lead sponsor
- Yonsei University
- Conditions
- Hormone Receptor(HR)-Positive, Low HER2 Advanced Breast Cancer Patients (HER2 IHC 1+ or 2+ & ISH Negative)
- Interventions
- Experimental treatment arm, Control treatment arm
- First posted
- 2025-02-20
- Last updated
- 2025-04-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS according to RECIST 1.1 in the ITT population. | from date of randomization until the date of first evidence of disease progression or date of death from any cause, whichever came first, assessed up to 36 months | Progression-free survival (PFS) is defined as the time from day 1 of the randomization to the first evidence of disease progression or death, whichever is earlier. |
| Secondary | OS | On treatment: Every 3-4 weeks from date of randomization until the date of of death from any cause, assessed up to 36 months | OS measured from the time of randomization to the time of death of any cause. |
| Secondary | ORR | From screening and every 9 weeks for 54 weeks from randomization and every 12 weeks after 54 weeks from randomization to objective (RECIST 1.1 defined) disease progression, withdrawal of subject consent, or unacceptable toxicity, up to 36 months | Objective response rate as defined as the proportion of patients with at least 1 visit response of partial response or complete response based on RECIST 1.1 by investigator assessment |
| Secondary | Progression-free survival (PFS2) | from date of randomization until the date of first evidence of second disease progression or date of death from any cause, whichever came first, assessed up to 36 months | PFS2 as defined time from randomization until second progression on next-line of treatment, as assessed by investigator or death due to any cause |
| Secondary | safety | From administration of the first dose of study treatment and every 3-4 weeks on treatment and until 90 days after the last administration of the investigational drug or the initiation of new antitumor therapy, up to 36 months | Adverse events by CTCAE 5.0 criteria. |
| Secondary | Quality of life (QoL) by EORTC-QLQ-C30 | From administration of the first dose of study treatment and every 9 weeks (±3 days) until 2 years (even after disease progression)) | Quality of life (QoL) measured by EORTC-QLQ-C30 evaluated by questionnaire |
| Secondary | Quality of life (QoL) by ORTC-QLQ-BR23 | From administration of the first dose of study treatment and every 9 weeks (±3 days) until 2 years (even after disease progression)) | Quality of life (QoL) measured by EORTC-QLQ-BR23 evaluated by questionnaire |
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/NCT06837792
GET https://conductscience.org/api/trials/v1/NCT06837792/registered