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NCT Number: NCT06340230

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, 110004, China

Location status: Recruiting

Location contact

Caigang Liu, MD

PRINCIPAL_INVESTIGATOR

Nan Niu, MD

CONTACT

[email protected]

+8618940256668

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

SHR-A1811 Injection + Adebrelimab Injection

Drug

Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

SHR-A1811 Injection

Drug

Drug: SHR-A1811 Injection

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

  5. Disease-free survival (DFS)

    Time frame: 5 years

  6. Event-free survival (EFS)

    Time frame: 5 years

  7. Health-related quality of life (HRQOL) (EORTC QLQ-C30)

    Time frame: During 18 weeks of the neoadjuvant treatment

    The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Core 30 (EORTC QLQ-C30)

  8. Health-related quality of life (HRQOL)

    Time frame: During 18 weeks of the neoadjuvant treatment

    The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire Breast Cancer (EORTC QLQ- BR23) will be used to measure the HRQOL

Study contacts

Contact information is provided by the study sponsor or research team.

Nan Niu, MD

CONTACT

[email protected]

86-18940256668

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Registry information

Official study title

A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2031
First posted
Apr 1, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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