Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a multicenter, observational, real-world investigation. The research plans to enroll 300 HER2-positive and HER2-low breast cancer patients who meet the inclusion criteria. All patients included in the analysis are currently receiving or are scheduled to receive a treatment regimen containing Trastuzumab-rezetecan. There are no restrictions on the treatment regimen, which is entirely based on the clinician's choice. The study aims to evaluate the efficacy and safety of the treatment regimen containing Trastuzumab-rezetecan.
After completing screening examinations and assessments, eligible patients will enter the study treatment phase. They will receive the treatment regimen containing Trastuzumab-rezetecan and undergo follow-up visits according to the protocol. During the study treatment period, patients will undergo imaging and safety assessments as per clinical routine, with the investigator's assessment serving as the final result. Upon treatment completion or study withdrawal, corresponding safety examinations and imaging assessment data will be collected. For neoadjuvant patients, pathological complete response (pCR) will be assessed post-surgery by pathologists at the participating centers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab-rezetecan Treatment Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab-rezetecan Treatment Group | Drug | Trastuzumab-rezetecan: 4.8 mg/kg (for HER2-positive) or 6.4 mg/kg (for HER2-low) per treatment cycle of 21 days. The dosage is to be adjusted at the discretion of the investigator based on the actual clinical situation. All patients will receive treatment with a regimen containing Trastuzumab-rezetecan as determined by the investigator. The regimens for other concomitant medications will be selected by the treating physician based on the patient's individual circumstances. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Assessed per NCI-CTCAE v5.0 criteria | From the signing of the informed consent form until 30 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response(pCR) | No residual invasive cancer is found upon evaluation of the excised breast tissue and regional lymph nodes | Estimated 7 years |
| Invasive disease free survival(iDFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
HER2-positive and HER2-low breast cancer patients, including all those analyzed who are currently receiving or plan to receive a treatment regimen containing Trastuzumab-rezetecan.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Time from randomization to the first occurrence of ipsilateral local/regional invasive recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.
| Estimated 7 years |
| Progression-free survival (PFS) | The date of randomization to the first documented disease progression (per RECIST 1.1) or death due to any cause, whichever occurred first | Estimated 7 years |
| Objective Response Rate (ORR) | The percentage of patients with ≥30% tumor shrinkage, as evaluated by investigators per RECIST 1.1 criteria | Estimated 7 years |
| Clinical Benefit Rate (CBR) | Sum of complete response [CR], partial response [PR], and SD lasting ≥24 weeks), as assessed by investigators according to RECIST 1.1 criteria | Estimated 7 years |
| Overall Survival (OS) | The duration from randomization to death event | Estimated 7 years |