T-DM1 Combined With CDK4/6 Inhibitor Ribociclib

NCT ID: NCT06481956

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2027-10-10

Brief 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.

Conditions

HER2-positive Advanced Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ribociclib Oral Tablet

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zheng Yabing

OTHER

Sponsor Role: lead

Responsible Party

Zheng Yabing

Deputy director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yabing Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

[2023]-06-10

Identifier Type: -

Identifier Source: org_study_id