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T-DM1 Combined With CDK4/6 Inhibitor Ribociclib

NCT06481956 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-01

No results posted yet for this study

Summary

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

Conditions

  • HER2-positive Advanced Breast Cancer

Interventions

DRUG

Ribociclib Oral Tablet

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.

Sponsors & Collaborators

  • Zheng Yabing

    lead OTHER

Principal Investigators

  • Yabing Zheng, MD · Zhejiang Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2027-01-10
Completion
2027-10-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06481956 on ClinicalTrials.gov