PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metast… (NCT06172127) | Clinical Trial Compass
Active — Not RecruitingPhase 2
PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer
United States, France165 participantsStarted 2024-07-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.
✓. Male or female patients ≥ 18 years of age at the time of signing ICF.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
✓. Life expectancy of ≥ 12 weeks at screening.
✓. Evidence of HER2-overexpressing tumor status confirmed by any MEDSIR's designated central lab or patient has a pathology report confirming HER2-overexpression by local testing, preferably on the most recent available metastatic sample. In the latest case, tumor tissue or blood must be sent to any MEDSIR's designated central lab for confirmation of HER2 status. Analysis of the primary tumor sample will be accepted if the metastatic tissue is inaccessible.
✓. Must have known estrogen receptor (ER) and progesterone receptor (PgR) status locally determined prior to study entry.
✓. Unresectable locally recurrent or MBC documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
✓. Evaluable disease as per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v.1.1) criteria.
Exclusion criteria
✕. Current participation in another therapeutic clinical trial, except other translational studies.
✕. Treatment with approved or investigational cancer therapy within 14 days prior to initiation of study drugs.
What they're measuring
1
1-year PFS rate
Timeframe: Baseline up to 12 months
2
3-year OS rate
Timeframe: Through study completion, an average of 36 months
✕. Has previously been treated with T-DXd in the adjuvant or neoadjuvant setting.
✕. Known active uncontrolled or symptomatic central nervous system (CNS) metastases and/or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
✕. Concurrent malignancy or malignancy within 5 years of study enrollment with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.
✕. Known allergy or hypersensitivity reaction to any investigational medicinal products (IMPs) or their incorporated substances.
✕. Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks prior to start of study treatment.
✕. Major surgical procedure or significant traumatic injury within 14 days before the first dose of study treatment or anticipation of need for major surgery within the course of the study treatment.