T-DM1 Combined With CDK4/6 Inhibitor Ribociclib

Sponsor
Zheng Yabing
Study ID
NCT06481956
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • HER2-positive Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib Oral Tablet — DRUG
    Patients with advanced breast cancer with at least one evaluable lesion and histologically proven invasive breast cancer were eligible for inclusion. Histopathologically positive for HER2 (IHC 3+, or IHC 2+ with fluorescence in situ hybridization (FISH) positive, either primary or metastatic. Patients with advanced breast cancer must have previously received first-line therapy or initial rescue therapy and have been treated with trastuzumab against HER2.

Study Details

To explore the efficacy and safety of T-DM1 combined with CDK4/6 inhibitor Ribociclib in the treatment of HER2-positive advanced breast cancer.

Key Dates

Start date
Oct 25, 2023
Status verified
Jun 2024
Primary completion
Jan 10, 2027
Completion
Oct 10, 2027

Study Design

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

Arms

  • Experimental: T-DM1 combined with Ribociclib
    Enrolled patients will receive (repeat every 21 days) : ● T-DM1 3.6 mg/kg d1;● Ribociclib 400 mg qd, d8-d21; \* ER-positive patients will receive endocrine therapy at the same time: aromatase inhibitors or fulvestrant , and ovarian suppression or ovariectomy in premenopausal women.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to 54 months ]

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