RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Trastuzumab deruxtecan for Invasive Breast Cancer

Q: Is NCT05795101 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT05795101?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT05795101?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This study wants 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

Official registry: https://clinicaltrials.gov/study/NCT05795101 · Filipa Lynce, MD · enrollment listed as 63

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Trastuzumab deruxtecan, or Durvalumab. The registry lists allocation as randomized. This study wants 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.

They plan to enroll about 63 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

TRUDI: A Phase II Study of Neoadjuvant Trastuzumab Deruxtecan and Durvalumab for Stage III, HER2-expressing Inflammatory Breast Cancer

Interventions: Trastuzumab deruxtecan, Durvalumab

Primary outcome (registry wording): Pathological complete response (pCR) Rate

Who it is for (from inclusion criteria)

Ages 18 Years to any
Women only
Participants must have a histological or cytological diagnosis of invasive breast cancer
All histologic subtypes are eligible
Participants must have a clinical diagnosis of stage III inflammatory breast cancer within the past 6 months
Any ER and PR expressions are permitted but must be known
Participants must be treatment-naïve
Pre- and postmenopausal women or male patients ≥ 18 years of age
how well you can do daily activities (ECOG score) 0-1 (Karnofsky \> 60%, see Appendix A)

Who the registry excludes

Has received prior systemic anti-cancer therapy for the current diagnosis of inflammatory breast cancer, including chemotherapy, immunotherapy, or targeted therapy
Has received any radiotherapy or surgery for the current diagnosis of inflammatory breast cancer. Tumor biopsies are not considered surgery for the purpose of enrollment
Prior hypersensitivity to durvalumab or the excipients of durvalumab or trastuzumab deruxtecan or history of severe hypersensitivity reactions to other monoclonal antibodies
Major surgery within 4 weeks prior to study treatment initiation. Patients must have recovered from any effects of any major surgery
History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Corrected QT interval (QTcF) prolongation to \> 470 msec on screening EKG
Cardiac ejection fraction outside institutional range of normal or \<50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition \[MUGA\] scan if an echocardiogram cannot be performed or is inconclusive)

Public study contact (from the registry)

Filipa Lynce, MD

(617) 632-3800

filipa_lynce@dfci.harvard.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

Brigham and Women's Hospital — Boston, Massachusetts (recruiting)
Dana Farber Cancer Institute — Boston, Massachusetts (recruiting)
University of Texas MD Anderson Cancer Center — Houston, Texas (recruiting)

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FAQ about this NCT record

Is NCT05795101 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05795101?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05795101?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary