PHESGO Maintenance After Initial T-DXd Treatment for HER2+ Advanced Breast Cancer

Sponsor: MedSIR

Sponsor score: 0

ClinicalTrials ID:NCT06172127

This study is testing a new treatment approach for patients with HER2-positive breast cancer that cannot be surgically removed or has spread. It involves starting with a drug called T-DXd and then switching to a combination of two drugs, trastuzumab and pertuzumab, given as a single injection under the skin.

Patient Parameters

Parameter	Options

Program Overview

The DEMETHER trial is a phase II study looking at how effective it is to start treatment with T-DXd and then switch to a maintenance treatment with PHESGO, a combination of trastuzumab and pertuzumab, for patients with HER2-positive breast cancer that cannot be removed by surgery or has spread. The study aims to see if this approach can help control the cancer for longer periods.

Description

The DEMETHER study is an international trial involving multiple centers, where all participants will receive the same treatment. It starts with a 6-cycle induction phase using T-DXd, followed by a maintenance phase with PHESGO. The study will include 165 participants who have not received prior chemotherapy or HER2-targeted therapy for advanced breast cancer, although one prior line of hormone therapy is allowed. Participants who have had chemotherapy before, with a gap of more than 12 months before the cancer returned, can also join.

Participants will continue the study treatment until their cancer progresses, they experience severe side effects, or up to 3 years after starting T-DXd, whichever comes first. After stopping the treatment, participants will have a safety check-up about a month later and will be followed up every 3 months to collect information on their health and any new cancer treatments they receive.

The main goals of the study are to see how long participants live without their cancer getting worse and their overall survival rate after 3 years. The study will end after the last participant has completed their safety visit, which will be about 3 years and 1 month after the last participant starts T-DXd treatment.

Eligibility Criteria

Inclusion Criteria

Must understand the study and sign a consent form.
Be 18 years or older.
Have a good performance status (ECOG 0 or 1).
Have a life expectancy of at least 12 weeks.
Have HER2-positive breast cancer confirmed by a lab.
Have known estrogen and progesterone receptor status.
Have cancer that cannot be surgically removed or has spread, confirmed by scans.
Have measurable disease according to specific criteria.
Be willing to provide a tumor sample.
Have not received prior chemotherapy or HER2-targeted therapy for advanced cancer, except for one line of hormone therapy.
May have received prior chemotherapy for early-stage cancer, with a gap of at least 12 months before the cancer returned.
Have adequate blood and organ function.
Have resolved any side effects from previous cancer treatments to a mild level.
Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
Men must agree to use effective birth control during and after the study.
Must be available for treatment and follow-up.

Exclusion Criteria

Currently in another clinical trial, except for certain studies.
Received cancer treatment within 14 days before starting the study.
Previously treated with T-DXd.
Have uncontrolled or symptomatic brain metastases.
Have another cancer within the last 5 years, except for certain low-risk cancers.
Have allergies to study drugs.
Received recent radiation therapy.
Had major surgery or significant injury recently.
Have active heart disease or history of heart problems.
Have severe lung disease or history of lung issues.
Pregnant or breastfeeding women.
Have active hepatitis B or C, or HIV infection.
Have uncontrolled infections.
Received a live vaccine recently.
Have uncontrolled seizures or psychiatric conditions.
Have any other severe medical condition that would interfere with the study.
Have a history of substance abuse.

Locations

FACILITY	ZIP	CITY	STATE
Northwell Health	11040	New York	New York

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