Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05795101 · ClinicalTrials.gov registry record · Phase 2
TRUDI: TDXD+Durva in HER2+/Low IBC
A Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by Filipa Lynce, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 3
- Study locations
NCT05795101: Recruiting Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by Filipa Lynce, MD.
NCT05795101 is a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer that is actively recruiting participants, run by Filipa Lynce, MD. The registered enrollment target is 63 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05795101, a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, is actively recruiting participants, sponsored by Filipa Lynce, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor Receptor-2 (HER2)-expressing inflammatory breast cancer. The names of the study drugs involved in this study are: * Trastuzumab deruxtecan * Durvalumab
Primary Outcome
pCR rate is the proportion of participants with absent invasive carcinoma in the breast and lymph nodes at time of surgery; in situ disease only is considered pCR; if off-treatment prior to surgery than considered not pCR.
Conditions Studied
Interventions
- DRUG Trastuzumab deruxtecan
- DRUG Durvalumab
Study Locations (3)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana Farber Cancer Institute - Boston
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2023-05-04 |
| Est. Completion | 2032-12-01 |
| Phase | Phase 2 |
What NCT05795101 shows while recruiting
NCT05795101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Trastuzumab deruxtecan is the first listed.
NCT05795101 reports a single indexed study location in Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT05795101 about?
NCT05795101 is a clinical study titled "TRUDI: TDXD+Durva in HER2+/Low IBC". The purpose of this study is to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor Receptor-2 (HER2)-expressing inflammatory breast cancer. The names of th...
What is the current status of trial NCT05795101?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2023-05-04. Estimated completion is 2032-12-01.
What conditions does trial NCT05795101 study?
This clinical trial studies the following conditions: Breast Cancer, HER2-positive Breast Cancer, Invasive Breast Cancer, Inflammatory Breast Cancer Stage III, HER2 Low Breast Adenocarcinoma.
What interventions are being tested in trial NCT05795101?
The interventions under investigation include: Trastuzumab deruxtecan (DRUG), Durvalumab (DRUG).
Who is sponsoring clinical trial NCT05795101?
This trial is sponsored by Filipa Lynce, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05795101 being conducted?
This trial has 3 study locations across Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05795101's enrollment target sits among peer trials
63 727th of 1224 higher than 495 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
RECRUITING · Phase 2
-
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
RECRUITING · Phase 2
-
Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
RECRUITING · Phase 2
-
Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial
RECRUITING · Phase 2
-
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
RECRUITING · Phase 2
-
Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03383575 · 63 participants · Phase 2
Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome
- NCT04870944 · 63 participants · Phase 1
CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma
- NCT05031897 · 63 participants · Phase 2
Two Step Haplo With Radiation Conditioning
- NCT05312671 · 63 participants · Phase 2
Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI