Clinical trial NCT06340230: SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
Official title: A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HR Positive/HER2 Low Breast Cancer
Keywords: SHR-A1811
Adebrelimab
Neoadjuvant
HR Positive/HER2 Low Breast Cancer
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2024-04-01
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total pathological complete response (tpCR: ypT0-is/ypN0)
timeFrame: At the time of surgery
Secondary outcomes:
measure: Breast pathological complete response (bpCR：ypT0-is)
timeFrame: At the time of surgery
measure: Residual cancer burden (RCB)
timeFrame: At the time of surgery
measure: Best overall response rate (BORR)
timeFrame: During 18 weeks of the neoadjuvant treatment
measure: Overall survival (OS)
timeFrame: 5 years
measure: Disease-free survival (DFS)
timeFrame: 5 years
measure: Event-free survival (EFS)
timeFrame: 5 years
measure: Health-related quality of life (HRQOL) (EORTC QLQ-C30)
timeFrame: During 18 weeks of the neoadjuvant treatment
measure: Health-related quality of life (HRQOL)
timeFrame: During 18 weeks of the neoadjuvant treatment
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital affiliated to China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Caigang Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: