Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-29 @ 11:50 PM
Study NCT ID:
NCT06172127
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2023-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer
Sponsor:
MedSIR
Organization:
Study Overview
Official Title:
A Multicenter, Open-Label, Single-Arm, Phase II Trial Exploring the Maintenance of Trastuzumab and Pertuzumab Following Trastuzumab Deruxtecan as Induction Treatment for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEMETHER
Brief 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.
Detailed Description:
DEMETHER is an international, multicenter, open-label, single arm phase II clinical trial designed to evaluate the efficacy of a 6-cycle induction phase with T-DXd treatment followed by a maintenance phase with PHESGO treatment in patients with HER2-positive unresectable locally recurrent or MBC.
Upon meeting all selection criteria, a total of 165 participants will be enrolled. Participants with no prior chemotherapy or HER2-targeted therapy for advanced or MBC (one prior line of endocrine therapy is allowed for MBC) will be eligible. Participants who have received neoadjuvant or adjuvant chemotherapy will be eligible, with a DFI from completion of systemic chemotherapy to advanced or metastatic diagnosis of \> 12 months.
Patients will continue study treatment until end of treatment (EoT) defined as the date of disease progression, death, discontinuation from the study treatment for any other reason, or up to 3 years (36 months) after T-DXd initiation, whichever occurs first. After discontinuation, all participants will undergo a safety visit at 28 (± 7 days) days after last treatment dose in order to follow up toxicities and changes in concomitant medication. Patients discontinuing the study treatment at any time will enter a post-treatment follow-up period during which survival and subsequent anticancer therapy information will be collected every 3 months (± 7 days) from the safety visit until death, lost to follow-up, elective withdrawal from the study, or the end of study (EoS), whichever occurs first.
The main objectives of DEMETHER study are to determine the efficacy of induction treatment with T-DXd followed by PHESGO as maintenance therapy in terms of progression-free survival (PFS) rate at 1 year and overall survival (OS) rate at 3 years.
End of study (EoS) is defined as the last data collection point at the last participant's safety visit and occur 36 months + 28 days (± 7 days) after the last patient included in the study initiates T-DXd treatment, unless premature termination of the study.
Upon meeting all selection criteria, a total of 165 participants will be enrolled. Participants with no prior chemotherapy or HER2-targeted therapy for advanced or MBC (one prior line of endocrine therapy is allowed for MBC) will be eligible. Participants who have received neoadjuvant or adjuvant chemotherapy will be eligible, with a DFI from completion of systemic chemotherapy to advanced or metastatic diagnosis of \> 12 months.
Patients will continue study treatment until end of treatment (EoT) defined as the date of disease progression, death, discontinuation from the study treatment for any other reason, or up to 3 years (36 months) after T-DXd initiation, whichever occurs first. After discontinuation, all participants will undergo a safety visit at 28 (± 7 days) days after last treatment dose in order to follow up toxicities and changes in concomitant medication. Patients discontinuing the study treatment at any time will enter a post-treatment follow-up period during which survival and subsequent anticancer therapy information will be collected every 3 months (± 7 days) from the safety visit until death, lost to follow-up, elective withdrawal from the study, or the end of study (EoS), whichever occurs first.
The main objectives of DEMETHER study are to determine the efficacy of induction treatment with T-DXd followed by PHESGO as maintenance therapy in terms of progression-free survival (PFS) rate at 1 year and overall survival (OS) rate at 3 years.
End of study (EoS) is defined as the last data collection point at the last participant's safety visit and occur 36 months + 28 days (± 7 days) after the last patient included in the study initiates T-DXd treatment, unless premature termination of the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: