Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT06481956
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06481956
Study Brief:
Protocol Section:
NCT06481956