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Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer

ConditionAdvanced Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

This study is a prospective, open-label, multicenter, randomized, parallel Phase II clinical trial. This study aims to investigate the efficacy and safety of trastuzumab rezetecan or trastuzumab deruxtecan in HER2 positive advanced/metastastic breast cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged ≥18 and ≤75 years.

Histologically or cytologically confirmed HER2-positive (IHC 3+ and/or ISH positive) unresectable or metastatic breast cancer.

Prior treatment with trastuzumab and a taxane in the recurrent or metastatic setting. Or recurrence during or within 12 months (disease-free interval, DFI) after completing neoadjuvant/adjuvant chemotherapy and/or anti-HER2 targeted therapy.

Documented radiological disease progression (during or after the most recent prior therapy).

Disqualifiers

Patients with known untreated spinal cord compression or active central nervous system (CNS) metastases, except for those who have been treated and have remained stable for at least 1 month and have discontinued corticosteroids for >2 weeks.

History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.

Uncontrolled third-space fluid accumulation (e.g., massive ascites, pleural effusion, pericardial effusion) that cannot be managed by drainage or other methods.

Having undergone major cancer-related surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biotherapy, or other clinical investigational therapy within 4 weeks prior to the first dose.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trastuzumab Rezetecan for Injection (SHR-A1811)

    Drug

    SHR-A1811 4.8mg/kg iv q3w

  • Trastuzumab Deruxtecan for Injection (T-DXd)

    Drug

    T-DXd 5.4mg/kg iv q3w

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: SHR-A1811Experimental treatment 1 intervention
Group B: T-DXdActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival(PFS)

Time from the date of randomization until the date of first documented radiological disease progression (PD) or death from any cause, whichever occurs first. If a subject did not experience PD or death by the data cutoff date, or had received other anti-tumor therapy, censoring occurred at the date of the last efficacy assessment prior to the cutoff date or the start date of other anti-tumor therapy, whichever was earlier.

Time frame
From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years

Secondary outcomes

1

Objective response rate (ORR)

The percentage of subjects in the analysis set whose best overall response (BOR) was a complete response (CR) or partial response (PR) from the start of the study treatment until the subject discontinued the study due to disease progression. It is recommended to use the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) to evaluate the objective tumor response. Subjects must have measurable tumor lesions at baseline, and the assessment of efficacy is recommended to be categorized according to RECIST 1.1 criteria into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).

Time frame
From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
2

Disease control rate(DCR)

The percentage of subjects in the analysis set whose best overall response (BOR) was complete response (CR), partial response (PR), or stable disease (SD) from the start of the study treatment regimen until the subject discontinued the study due to disease progression. It is recommended to use the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) to assess the objective tumor response. Subjects must have measurable tumor lesions at baseline, and the efficacy assessment is recommended to be categorized according to RECIST 1.1 criteria as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).

Time frame
From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
3

Duration of Response(DOR)

defined as the time from the date of first documented response (complete response, CR, or partial response, PR, whichever occurs first) to the date of disease progression or death, whichever occurs earlier. Response is assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Time frame
From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years
4

Overall survival (OS)

Defined as the time from the date of enrollment to the date of death from any cause. For subjects who were alive at the last follow-up, their OS data are censored at the date of the last follow-up. For subjects who were lost to follow-up, their OS data are censored at the date of the last documented evidence of survival prior to being lost. Censored OS is defined as the time from enrollment to censoring.

Time frame
From the date of randomization up to the date of death due to any cause, up to approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: