Clinical trial NCT06481956: T-DM1 Combined With CDK4/6 Inhibitor Ribociclib
Official title: Phase II Clinical Study of Trastuzumab Emtansine (T-DM1) Combined With Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitor Ribociclib in the Treatment of Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: HER2-positive Advanced Breast Cancer
Keywords: HER2-positive
Advanced breast cancer
Trastuzumab Emtansine
Ribociclib
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 54 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: up to 54 months
measure: 2-year Overall Survival (OS)
timeFrame: up to 54 months
measure: Objective Response Rate of Subgroup Population (ORR)
timeFrame: up to 54 months
measure: Adverse Event (AE)
timeFrame: up to 54 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Yabing Zheng, MD
role: PRINCIPAL_INVESTIGATOR
References: