Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: … (NCT07179939) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study
China288 participantsStarted 2025-09-10
Plain-language summary
This is a phase II trial exploring the maintenance therapy with trastuzumab combined with pyrotinib or dalpiciclib and endocrine therapy in HER2-positive advanced breast cancer based on different hormone receptor (HR) statuses following trastuzumab rezetecan (T-DXh, SHR-A1811) as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer (MBC) patients.
Who can participate
Age range18 Years
SexFEMALE
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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.
✓. Female patients ≥ 18 years of age at the time of signing ICF.
✓. Breast Cancer Requirements:
✓. Histologically or cytologically confirmed HER2-positive(IHC 3+ or ISH+) unresectable locally advanced or metastatic breast cancer (Note: Patients eligible for curative-intent treatment are excluded).
✓. Documented hormone receptor (HR) status.
✓. No prior systemic anti-tumor therapy for recurrent/metastatic disease (≤1 line of endocrine therapy is permitted\*).
✓. For patients who received (neo)adjuvant therapy: \>12 months between the end of systemic treatment (excluding endocrine therapy) and recurrence/metastasis.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion criteria
✕. Known active CNS metastases not treated with surgery or radiotherapy, except for those who have achieved stable disease for ≥1 month after treatment and have discontinued corticosteroids for \>2 weeks.
✕. Received major cancer-related surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biologic therapy, or investigational drug therapy within 4 weeks prior to the first dose of study treatment.
What they're measuring
1
PFS
Timeframe: From the date of treatment initiation until to the first occurrence of disease progression as determined locally by the investigator assessment using RECIST v.1.1 or death from any cause, whichever occurs first，assessed up to 60 months