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NCT06172127 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of HER2-positive Breast Cancer, sponsored by MedSIR.

Recruiting
Registry status
Phase 2
Development phase
165
Enrollment target
20
Study locations

NCT06172127: Recruiting Phase 2 study of HER2-positive Breast Cancer, sponsored by MedSIR.

NCT06172127 is a Phase 2 study of HER2-positive Breast Cancer that is actively recruiting participants, run by MedSIR. The registered enrollment target is 165 participants, below the 233-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06172127, a Phase 2 study of HER2-positive Breast Cancer, is actively recruiting participants, sponsored by MedSIR.

RECRUITING
Registry status
Phase 2
Development phase
165 participants
Enrollment target
20
Study locations

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.

Primary Outcome

To determine the rate of patients with absence of disease progression or death from any cause at 1 year after the treatment initiation with T-DXd followed by PHESGO, as determined locally by the investigator using RECIST v.1.1

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
MedSIR

1 total trials

What NCT06172127 shows while recruiting

NCT06172127 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 233-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (29% lower).

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.

NCT06172127 names 20 study sites across 3 states, led by Other, Massachusetts, New York.

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.

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).

Who is sponsoring clinical trial NCT06172127?

This trial is sponsored by MedSIR, which has 1 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for HER2-positive 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 NCT06172127's enrollment target sits among peer trials

165 17th of 58 higher than 42 of 58 other HER2-positive Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HER2-positive 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

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Source: ClinicalTrials.gov NCT06172127, the US trial registry maintained by the National Library of Medicine. NCT06172127 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.