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A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer

ConditionsUnresectable Locally Recurrent Breast CancerUnresectable Locally Metastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

The study is designed to compare the efficacy and safety of different dose groups of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in patients with HR-positive, HER2-low unresectable locally recurrent/metastatic breast cancer. It will also exploratively evaluate the pharmacokinetic profile and immunogenicity of Trastuzumab Rezetecan.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female aged 18 to 75 years (inclusive).

Unresectable locally recurrent or metastatic breast cancer.

Prior therapy must meet the following: No prior chemotherapy for recurrent/metastatic disease. Must have received at least one prior line of endocrine therapy for recurrent/metastatic disease with disease progression, and the investigator judges that further benefit from endocrine therapy is not possible.

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

Disqualifiers

Presence of leptomeningeal metastasis/carcinomatous meningitis, spinal cord compression, or active central nervous system metastases.

Patients with only skin or brain lesions as target lesions.

History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.

Presence of carcinomatous lymphangitis, or third-space fluid accumulation that cannot be controlled by methods such as drainage.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trastuzumab Rezetecan for Injection

    Drug

    Trastuzumab Rezetecan for injection.

  • Trastuzumab Deruxtecan for Injection

    Drug

    Trastuzumab Deruxtecan for injection.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Trastuzumab Rezetecan for InjectionExperimental treatment 1 intervention
Group B: Trastuzumab Deruxtecan for InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS).

Time frame
Every 6 weeks after administration, approximately 14 months.

Secondary outcomes

1

Objective response rate (ORR).

Time frame
Every 6 weeks after administration, approximately 14 months.
2

Duration of response (DoR).

Time frame
Every 6 weeks after administration, approximately 14 months.
3

Clinical benefit rate (CBR).

Time frame
Every 6 weeks after administration, approximately 14 months.
4

Adverse events (AEs).

Graded according to NCI-CTCAE version 5.0.

Time frame
From the first dose administration until 40 days after the last dose administration.

Other outcomes

Sponsors and contacts

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

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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