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A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer

ConditionTriple Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

It is a randomized, open label, positive drug controlled, multicenter design Phase III clinical trial, aims to compare the efficacy and safety of SHR-A1811 combined with Adebrelimab and the treatment selected by the researchers in the adjuvant treatment of triple negative breast cancer with invasive residual cancer after neoadjuvant treatment, and to explore the PK characteristics and immunogenicity of SHR-A1811 and Adebrelimab.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed invasive triple negative breast cancer.

Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy.

Previous neoadjuvant therapy must meet the requirements of the protocol.

Has received radical surgery for breast cancer.

Disqualifiers

Stage IV metastatic breast cancer.

Previous invasive breast cancer or ductal carcinoma in situ.

Bilateral breast cancer.

Any clinical evidence indicating the exist of recurrent diseases after surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trastuzumab Rezetecan for Injection

    Drug

    Trastuzumab Rezetecan for Injection.

  • Adebrelimab Injection

    Drug

    Adebrelimab Injection.

  • Capecitabine tablets

    Drug

    Capecitabine Tables.

  • Pembrolizumab injection

    Drug

    Pembrolizumab Injection.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Trastuzumab Rezetecan combined with Adebrelimab GroupExperimental treatment 2 interventions
Group B: Capecitabine and PembrolizumabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Invasive disease-free survival (iDFS)

Time frame
Until study completion, assessed up to approximately 5 years.

Secondary outcomes

1

Disease-free survival (DFS)

Time frame
Until study completion, assessed up to approximately 5 years.
2

Overall survival (OS)

Time frame
Until study completion, assessed up to approximately 5 years.
3

DRFI (Distant recurrence-free interval)

Time frame
Until study completion, assessed up to approximately 5 years.
4

Adverse events (AEs)

Time frame
Until study completion, assessed up to approximately 2 years.

Other outcomes

Sponsors and contacts

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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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