Efficacy and Safety of Trastuzumab-rezetecan in HER2-Expressing Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, with pathologically confirmed HER2-positive or HER2-low-expressing breast cancer: HER2-positive is defined as IHC 3+ or IHC 2+ with a positive ISH result; HER2-low-expressing is defined as IHC 1+ or IHC 2+ with a negative ISH result for HER2 amplification; hormone receptor status must be clearly documented.
Planned to receive treatment with Trastuzumab-rezetecan for Injection in the neoadjuvant, adjuvant, or advanced/metastatic setting; patients with advanced/metastatic disease must have progressed after at least one prior line of systemic therapy.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to enrollment, and both male and female patients must be willing to use a highly effective, medically approved method of contraception during the study and for 1 year after the last dose of the study drug.
Disqualifiers
Any evidence of severe or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding disorders, active infections (such as hepatitis B, hepatitis C, and human immunodeficiency virus), or severely impaired bone marrow reserve or organ function (including hepatic and renal impairment), which, in the investigator's opinion, would significantly alter the risk-benefit balance.
At the initiation of treatment with Trastuzumab-rezetecan for Injection, the patient has not recovered from any prior treatment-related toxicity of CTCAE grade >3.
Known history of hypersensitivity to Trastuzumab-rezetecan for Injection, its excipients, or drugs with similar chemical structures or classes as Trastuzumab-rezetecan.
Patients deemed unsuitable for enrollment by the investigator.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Trastuzumab-rezetecan Treatment Group
DrugTrastuzumab-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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Trastuzumab-rezetecan Treatment Group1 intervention
Trial outcomes
Primary outcomes
1
Adverse events (AEs)
Assessed per NCI-CTCAE v5.0 criteria
Time frame
From the signing of the informed consent form until 30 days after the last doseSecondary outcomes
1
Pathological Complete Response(pCR）
No residual invasive cancer is found upon evaluation of the excised breast tissue and regional lymph nodes
Time frame
Estimated 7 years2
Invasive disease free survival(iDFS)
Time from randomization to the first occurrence of ipsilateral local/regional invasive recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.
Time frame
Estimated 7 years3
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
Time frame
Estimated 7 years4
Objective Response Rate (ORR)
The percentage of patients with ≥30% tumor shrinkage, as evaluated by investigators per RECIST 1.1 criteria
Time frame
Estimated 7 yearsSponsors and contacts
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Source ClinicalTrials.gov