Clinical trial · Interventional
T-DM1 Combined With CDK4/6 Inhibitor Ribociclib
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
NCT06481956CI-TRIAL-00078449enrolling by invitationPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Advanced Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ribociclib Oral Tablet | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- T-DM1 combined with Ribociclib
- description
- 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.
- interventionNames
- Drug: Ribociclib Oral Tablet
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 54 months
- description
- 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 outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.