A Multicenter, Single-arm, Phase 2 Study of Neoadjuvant SHR-A1811 Plus Adebrelimab Injection for Early-stage or Locally Advanced HR Negative or Low Expression/HER2 Low Expression Breast Cancer

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country60 target enrollmentSeptember 20, 2024

ConditionsUntreated Early-stage or Locally Advanced Breast Cancer

InterventionsSHR-A1811 Adebrelimab

DrugsSHR-A1811 Adebrelimab

Overview

Phase: Phase 2
Intervention: SHR-A1811
Conditions: Untreated Early-stage or Locally Advanced Breast Cancer
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 60
Locations: 1
Primary Endpoint: Investigator-assessed tpCR
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being conducted to evaluate the preliminary efficacy, safety, and pharmacokinetic characteristics of the combination of SHR-A1811 with Adebrelimab Injection in treatment-naive patients with early-stage or locally advanced HR-negative or low expression, HER2 low expression breast cancer.

Registry

clinicaltrials.gov

Start Date

September 20, 2024

End Date

February 28, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female treatment-naïve patients aged ≥18 years and ≤75 years.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-
•Breast cancer meeting the following criteria:
•Histologically confirmed invasive breast cancer with at least one tumor lesion \>2 cm in diameter.
•Clinical stage II or III.
•Histologically or cytologically confirmed HR-negative or low expression and HER2 low expression breast cancer.
•Adequate major organ function.
•Females of childbearing potential must agree to use highly effective contraception methods and avoid egg donation, and must have a negative serum pregnancy test within 7 days prior to the first treatment and during the study period. They must not be breastfeeding.
•Voluntarily agrees to participate in the clinical study and signs the informed consent form.

Exclusion Criteria

•Tumor-related medical history and treatment history:
•Bilateral breast cancer (including contralateral carcinoma in situ).
•Stage IV (metastatic) breast cancer.
•Inflammatory breast cancer.
•Diagnosis of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) within 5 years.
•History of invasive breast cancer or metastatic breast cancer.
•Prior surgical resection of the breast primary lesion or axillary lymph nodes before signing the informed consent.
•Diagnosis of any malignancy within 5 years before signing the informed consent, excluding adequately treated cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cellcancer.
•Previous systemic targeted therapy, endocrine therapy, radiotherapy, or immunotherapy for any malignancy.
•Any of the following comorbidities/ medical history or treatment history:

Arms & Interventions

SHR-A1811 plus Adebrelimab

Intervention: SHR-A1811

SHR-A1811 plus Adebrelimab

Intervention: Adebrelimab

Outcomes

Primary Outcomes

Investigator-assessed tpCR

Time Frame: Approximately 18 weeks after the first dose (after breast cancer surgery

Secondary Outcomes

Objective Response Rate (ORR)(Approximately 18 weeks after the first dose (before breast cancer surgery))
Change in Ki-67 index(Approximately 18 weeks after the first dose (after breast cancer surgery))
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)(From signing the informed consent form to 40 days after the last dose of SHR-A1811, or 90 days after the last dose of Adebrelimab Injection (whichever is later))