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SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

ConditionHR Positive/HER2 Low Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShengjing Hospital

About this trial

This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged ≥ 18 but ≤ 75 years

Histologically confirmed to be HR+/HER2-Low invasive breast cancer

Treatment-naive patients with stage II-III

Eastern Cooperative Oncology Group (ECOG) score is 0 or 1

Disqualifiers

Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)

Received any other anti-tumor therapy at the same time

Bilateral breast cancer, inflammatory breast cancer or occult breast cancer

Stage IV breast cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A1811 Injection + Adebrelimab Injection

    Drug

    Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

  • SHR-A1811 Injection + Adebrelimab Injection

    Drug

    Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

  • SHR-A1811 Injection

    Drug

    Drug: SHR-A1811 Injection

Treatment groups

93 Participants
are divided into 3 treatment groups
Group A: Arm 1 (PD-L1 Positive) SHR-A1811 Injection + Adebrelimab InjectionExperimental treatment 1 intervention
Group B: Arm 2 (PD-L1 Negative) SHR-A1811 Injection + Adebrelimab InjectionExperimental treatment 1 intervention
Group C: Arm 3 SHR-A1811 InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total pathological complete response (tpCR: ypT0-is/ypN0)

Time frame
At the time of surgery

Secondary outcomes

1

Breast pathological complete response (bpCR：ypT0-is)

Time frame
At the time of surgery
2

Residual cancer burden (RCB)

Time frame
At the time of surgery
3

Best overall response rate (BORR)

Time frame
During 18 weeks of the neoadjuvant treatment
4

Overall survival (OS)

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Shengjing Hospital

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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