Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)

NCT04622319 · View on ClinicalTrials.gov ↗

Study Summary

Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.

Interventions

  • DRUG T-DM1
  • DRUG DS-8201a

Study Locations (20)

California

  • The Oncology Institute of Hope & Innovation — Anaheim
  • Kaiser Permanente — Anaheim
  • Kaiser Permanente — Baldwin Park
  • Kaiser Permanente — Bellflower
  • Kaiser Permanente — Fontana
  • Orange Coast Blood and Cancer Care — Fountain Valley
  • Kaiser Permanente — Harbor City
  • Kaiser Permanente — Irvine
  • Long Beach Memorial TCI — Long Beach
  • Kaiser Permanente — Los Angeles
  • Kaiser Permanente — Ontario
  • Kaiser Permanente — Panorama City
  • Kaiser Permanente — Riverside
  • Kaiser Permanente — San Diego
  • Kaiser Permanente — San Marcos
  • Kaiser Permanente — West Los Angeles
  • Kaiser Permanente — Woodland Hills

Florida

  • SCRI FCS North- Altamonte — Altamonte Springs
  • SCRI FCS South- Bonita — Bonita Springs
  • SCRI FCS North- Brandon Cancer Center — Brandon

Trial Details

FieldValue
Enrollment Target 1,600 participants
Start Date 2020-12-04
Est. Completion 2030-12-31
Phase Phase 3

Sponsor

Daiichi Sankyo

157 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04622319

The ClinicalTrials.gov registry entry for NCT04622319 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with HER2-Positive Primary Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which T-DM1 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04622319 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04622319 about?

NCT04622319 is a clinical study titled "A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)". Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of tras...

What is the current status of trial NCT04622319?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,600 participants. The study started on 2020-12-04. Estimated completion is 2030-12-31.

What conditions does trial NCT04622319 study?

This clinical trial studies the following conditions: HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04622319?

The interventions under investigation include: T-DM1 (DRUG), DS-8201a (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04622319?

This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04622319 being conducted?

This trial has 20 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial