T-DM1 Combined With CDK4/6 Inhibitor Ribociclib

NCT06481956 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: [2023]-06-10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Advanced Breast Cancer

Keywords

HER2-positive; Advanced breast cancer; Trastuzumab Emtansine; Ribociclib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is defined as the percentage of patients who achieved a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by the Investigator: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  up to 54 months

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  up to 54 months

• 2-year Overall Survival (OS)

  up to 54 months

• Objective Response Rate of Subgroup Population (ORR)

  up to 54 months

• Adverse Event (AE)

  up to 54 months

Study Arms (1)

T-DM1 combined with Ribociclib

EXPERIMENTAL

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.

Drug: Ribociclib Oral Tablet

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.

T-DM1 combined with Ribociclib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zheng Yabing: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Interventions

ribociclib

Study Officials

• Yabing Zheng, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy director

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: October 25, 2023
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): October 10, 2027
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

CN (1)