HER2-positive Advanced Breast Cancer
Conditions
Keywords
HER2-positive, Advanced breast cancer, Trastuzumab Emtansine, Ribociclib
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.
Interventions
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
Zheng Yabing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | up to 54 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | up to 54 months | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first. |
| 2-year Overall Survival (OS) | up to 54 months | the overall survival rate in all patients from the date of first dose to the end of follow-up at 2 years. |
| Objective Response Rate of Subgroup Population (ORR) | up to 54 months | Objective Response Rate of subgroup population (ER\>=10% vs ER\<10%) |
| Adverse Event (AE) | up to 54 months | Evaluation performed using the National Cancer Institute (NCI)- Standard for Common Terminology for Adverse Events (CTCAE)v.5.0. |
Countries
China
Outcome results
None listed