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

NCT ID: NCT06340230

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-23

Study Completion Date

2031-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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HR Positive/HER2 Low Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

SHR-A1811 Injection + Adebrelimab Injection

Intervention Type DRUG

Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

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

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

Group Type EXPERIMENTAL

SHR-A1811 Injection + Adebrelimab Injection

Intervention Type DRUG

Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

Arm 3 SHR-A1811 Injection

SHR-A1811 Injection Drug: SHR-A1811 Injection

Group Type EXPERIMENTAL

SHR-A1811 Injection

Intervention Type DRUG

Drug: SHR-A1811 Injection

Interventions

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SHR-A1811 Injection + Adebrelimab Injection

Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

Intervention Type DRUG

SHR-A1811 Injection + Adebrelimab Injection

Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

Intervention Type DRUG

SHR-A1811 Injection

Drug: SHR-A1811 Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Female patients aged ≥ 18 but ≤ 75 years
2. Histologically confirmed to be HR+/HER2-Low invasive breast cancer
3. Treatment-naive patients with stage II-III
4. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1
5. Good level of organ function
6. Subjects must participate voluntarily, sign the informed consent form, have good compliance, and cooperate with follow-up visits

Exclusion Criteria

1. Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
2. Received any other anti-tumor therapy at the same time
3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
4. Stage IV breast cancer
5. Not confirmed by histopathology
6. With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
7. Participated in other drug clinical trials within 4 weeks before enrollment
8. Known allergic history of the drug components of this protocol
9. History of immunodeficiency
10. Clinically significant cardiovascular diseases
11. Known or suspected interstitial lung disease
12. Active hepatitis and liver cirrhosis
13. Known hereditary or acquired bleeding thrombotic tendency
14. History of neurological or psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Caigang Liu

Director of the Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caigang Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Locations

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Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nan Niu, MD

Role: CONTACT

[email protected]
86-18940256668

Facility Contacts

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Nan Niu, MD

Role: primary

[email protected]
+8618940256668

Other Identifiers

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BC-NEO-IIT-SHR-A1811-SHR1316

Identifier Type: -

Identifier Source: org_study_id