NCT06340230

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_2

Timeline
58mo left

Started Aug 2024

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Aug 2024Feb 2031

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 23, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2031

Expected
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

1.5 years

First QC Date

March 25, 2024

Last Update Submit

December 2, 2024

Conditions

HR Positive/HER2 Low Breast Cancer

Keywords

SHR-A1811AdebrelimabNeoadjuvantHR Positive/HER2 Low Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

    At the time of surgery

Secondary Outcomes (8)

  • Breast pathological complete response (bpCR：ypT0-is)

    At the time of surgery

  • Residual cancer burden (RCB)

    At the time of surgery

  • Best overall response rate (BORR)

    During 18 weeks of the neoadjuvant treatment

  • Overall survival (OS)

    5 years

  • Disease-free survival (DFS)

    5 years

  • +3 more secondary outcomes

Study Arms (3)

Arm 1 (PD-L1 Positive) SHR-A1811 Injection + Adebrelimab Injection

EXPERIMENTAL

SHR-A1811 Injection + Adebrelimab Injection Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

Drug: SHR-A1811 Injection + Adebrelimab Injection

Arm 2 (PD-L1 Negative) SHR-A1811 Injection + Adebrelimab Injection

EXPERIMENTAL

SHR-A1811 Injection + Adebrelimab Injection Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

Drug: SHR-A1811 Injection + Adebrelimab Injection

Arm 3 SHR-A1811 Injection

EXPERIMENTAL

SHR-A1811 Injection Drug: SHR-A1811 Injection

Drug: SHR-A1811 Injection

Interventions

SHR-A1811 Injection + Adebrelimab InjectionDRUG

Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

Arm 1 (PD-L1 Positive) SHR-A1811 Injection + Adebrelimab Injection
SHR-A1811 InjectionDRUG

Drug: SHR-A1811 Injection

Arm 3 SHR-A1811 Injection

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Good level of organ function
  • Subjects must participate voluntarily, sign the informed consent form, have good compliance, and cooperate with follow-up visits

You may not qualify if:

  • 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
  • Not confirmed by histopathology
  • With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
  • Participated in other drug clinical trials within 4 weeks before enrollment
  • Known allergic history of the drug components of this protocol
  • History of immunodeficiency
  • Clinically significant cardiovascular diseases
  • Known or suspected interstitial lung disease
  • Active hepatitis and liver cirrhosis
  • Known hereditary or acquired bleeding thrombotic tendency
  • History of neurological or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Study Officials

  • Caigang Liu, MD

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Niu, MD

CONTACT

86-18940256668niunannancy@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Cancer Center

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start

August 23, 2024

Primary Completion

February 28, 2026

Study Completion (Estimated)

February 28, 2031

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations

CN(1)