Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study

Sponsor
Fudan University
Study ID
NCT07179939
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab rezetecan — DRUG
    Trastuzumab rezetecan is a lyophilized powder for injection intravenously. Administered according to label.
  • Pyrotinib — DRUG
    320 mg/d, q.d., p.o. A course of treatment need 21 days.
  • Dalpiciclib — DRUG
    125 mg/d, q.d., p.o. day 1-21, every 28 days.
  • Trastuzumab — DRUG
    Administered according to label.
  • ET: Letrozole/ Anastrozole/ Exemestane/ Fulvestrant/ Leuprorelin/ Goserelin. — DRUG
    Administered according to label.

Study Details

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.

Key Dates

First listed
Sep 18, 2025
Start date
Sep 10, 2025
Status verified
Aug 2025
Primary completion
Dec 30, 2030
Completion
Dec 30, 2031

Study Design

Enrollment
288 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    All patients will receive a 6-cycle induction phase with T-DXh 4.8 mg/kg body weight administered as an intravenous (IV) infusion on day 1 (D1) of each 21-day cycle (Q3W). Participants may continue with maintenance treatment if T-DXh is discontinued prematurely due to unacceptable toxicity prior to disease progression. During the maintenance phase, participants with HR positive disease will receive trastuzumab combined with dalpiciclib and endocrine therapy and for those with HR negative disease will receive trastuzumab combined with pyrotinib.

Primary Outcome Measure

PFS [ Time Frame: 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 ]

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