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RECRUITING Phase 2

PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer

NCT06172127 · View on ClinicalTrials.gov ↗

Study Summary

DEMETHER is a phase II trial exploring the maintenance of trastuzumab and pertuzumab fixed dose combination (FDC) for subcutaneous administration (SC, PHESGO) following trastuzumab deruxtecan (T-DXd) as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer (MBC) patients.

Interventions

  • DRUG Trastuzumab deruxtecan
  • DRUG Phesgo 1,200 MG / 600 MG / 30,000 UNT Per 15 ML Injection
  • DRUG Phesgo 600 MG / 600 MG / 20,000 UNT in 10 mL Injection

Study Locations (20)

Other

  • Institute Paoli Calmettes — Marseille
  • Hopital Europeen Georges Pompidou — Paris
  • Hôpital Tenon AP-HP — Paris
  • Marienhospital Bottrop GmbH Klinik für Gynäkologie und Geburtshilfe — Bottrop
  • Kliniken Essen Mitte — Essen
  • Mammazentrum HH — Hamburg
  • Klinikum der Universität München — München
  • Humanitas Gavazzeni — Bergamo
  • Instituto Europeo di Oncologia — Milan
  • University Hospital Maggiore della Carita — Novara
  • Fondazione Policlinico Universitario Agostino Gemelli — Roma
  • Hospital del Vinalopó — Alicante
  • Hospital General Universitario Dr. Balmis (Alicante) — Alicante
  • Hospital Clínic i Provincial de Barcelona — Barcelona
  • Hospital Universitari Dexeus — Barcelona
  • Institut Català d' Oncologia L'Hospitalet (ICO) — Barcelona
  • Hospital Universitario de Basurto — Bilbao
  • Hospital Provincial de Castellón — Castellon

Massachusetts

  • Dana-Farber Cancer Institute — Boston

New York

  • Northwell Health — New York

Trial Details

FieldValue
Enrollment Target 165 participants
Start Date 2024-07-22
Est. Completion 2029-05
Phase Phase 2

Sponsor

MedSIR

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06172127

The ClinicalTrials.gov registry entry for NCT06172127 describes a study currently listed as recruiting. It is categorized as Phase 2, 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 165 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedSIR, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Trastuzumab deruxtecan 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: NCT06172127 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Other, Massachusetts, New York. 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 NCT06172127 about?

NCT06172127 is a clinical study titled "PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer". DEMETHER is a phase II trial exploring the maintenance of trastuzumab and pertuzumab fixed dose combination (FDC) for subcutaneous administration (SC, PHESGO) following trastuzumab deruxtecan (T-DXd) as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer ...

What is the current status of trial NCT06172127?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2024-07-22. Estimated completion is 2029-05.

What conditions does trial NCT06172127 study?

This clinical trial studies the following conditions: HER2-positive 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 NCT06172127?

The interventions under investigation include: Trastuzumab deruxtecan (DRUG), Phesgo 1,200 MG / 600 MG / 30,000 UNT Per 15 ML Injection (DRUG), Phesgo 600 MG / 600 MG / 20,000 UNT in 10 mL Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06172127?

This trial is sponsored by MedSIR, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06172127 being conducted?

This trial has 20 study locations across Massachusetts, New York. 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