T-DM1 Combined With CDK4/6 Inhibitor Ribociclib

Trial Title: T-DM1 Combined With CDK4/6 Inhibitor Ribociclib

NCT ID: NCT06481956

Condition: HER2-positive Advanced Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
HER2-positive
Advanced breast cancer
Trastuzumab Emtansine
Ribociclib

Study type: Interventional

Study phase: Phase 2

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Ribociclib Oral Tablet
Description: 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.
Arm group label: T-DM1 combined with Ribociclib

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.

Detailed description: This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Trastuzumab Emtansine (T-DM1) combined with CDK4/6 inhibitor Ribociclib in the treatment of unresectable locally advanced or metastatic HER2-positive breast cancer.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age ≥18 at the time of signing the informed consent. - Patient's ability to follow the study protocol as determined by the investigator. - A representative tumor tissue sample is required to confirm a HER2-positive diagnosis. HER2 expression status and ER expression status of invasive cancer lesions were determined based on previous pathological sections or current pre-treatment biopsy materials, and the HER2 IHC assay was locally confirmed to be consistent with 3+, or IHC assay with 2+, and further FISH detection was positive before study enrollment. - At least one evaluable lesion was detected by CT or MRI (see protocol for additional details). - For metastatic or recurrent breast cancer, there is currently no opportunity for surgical radical resection. - Metastatic or recurrent breast cancer that has received at least first-line rescue therapy in the past must have been treated with trastuzumab and taxanes. - The Physical status (ECOG) score of the Eastern Tumor Collaboration group was 0 or 1. - Sufficient haematology and organ function to meet the definition of laboratory test results, which must be provided within 14 days before the start of study therapy. - Fertile women should remain abstinent (no heterosexual intercourse) or use contraceptive methods. Exclusion Criteria: - Past treatment with other antibody-drug conjugate (ADC) drugs or anti-tumor therapy with CDK4/6 inhibitors. - Past treatment with other anti-HER2 drugs other than trastuzumab, pertuzumab and tyrosine kinase inhibitors (TKI). - Advanced breast cancer with central nervous system metastasis. - Patients who have developed other malignancies in the 5 years prior to screening, except adequately treated cervical cancer in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer. - Severe dysfunction of vital organs prior to enrollment (see protocol details). - Received an investigational drug within 28 days prior to initiation of study therapy. - Known hypersensitivity or hypersensitivity to CDK4/6 inhibitors. - The results of the serum pregnancy test were positive.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Zip: 310022
Country: China

Start date: October 25, 2023

Completion date: October 10, 2027

Lead sponsor:
Agency: Zheng Yabing
Agency class: Other

Source: Zhejiang Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06481956