PHESGO Maintenance After T-DXd Induction for HER2+ Breast Cancer
This study, called DEMETHER, is for people with HER2-positive (a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2) unresectable locally recurrent or metastatic breast cancer. It's looking at how well two medicines, Trastuzumab deruxtecan (T-DXd) and Phesgo, work together. You would first receive T-DXd, followed by Phesgo as a maintenance treatment. Researchers want to see how long people live without their cancer getting worse (1-year PFS rate) and how long they live overall (3-year OS rate). The study is looking for about 165 participants who are at least 18 years old and have HER2-positive breast cancer.
- Study design
- This is an international, multicenter, open-label, single-arm Phase II clinical trial planning to enroll 165 participants.
- What's involved
- You would receive T-DXd treatment for 6 cycles, followed by Phesgo treatment. Treatment continues until disease progression, death, discontinuation, or up to 3 years after T-DXd starts.
- Compensation
- Not stated in the trial record.
- Follow-up
- After stopping treatment, you will have a safety visit about 28 days later. Researchers will also track your overall survival for an average of 36 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer
At a glance
Conditions
Where it's being run
36 sites across 7 statesStudy leadership
- Javier Cortés, MD, PhD · PRINCIPAL_INVESTIGATOR · Institute of Breast Cancer, Quirón Group, Barcelona (Spain)
- Antonio Llombart-Cussac, MD · PRINCIPAL_INVESTIGATOR · Arnau de Vilanova Hospital, Valencia (Spain)
- José M Pérez-García, MD · PRINCIPAL_INVESTIGATOR · International Breast Cancer Center (Spain)
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- 1-year PFS rateBaseline up to 12 months
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
- 3-year OS rateThrough study completion, an average of 36 months
To determine the rate of patients alive at 3 years after treatment initiation with T-DXd followed by PHESGO.