Clinical trial NCT05635487: A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Official title: A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HER2-positive Breast Cancer
Keywords: SHR-A1811
Pyrotinib
HER2-positive Breast Cancer
Neoadjuvant
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2022-12-02
Enrollment: 65
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 a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.


Eligibility criteria: Inclusion Criteria:

* Female patients aged ≥ 18 but ≤ 75 years
* Histologically confirmed to be HER2-positive invasive breast cancer
* Treatment-naive patients with stage II-III
* Eastern Cooperative Oncology Group (ECOG) score 0-1
* Good level of organ function

Exclusion Criteria:

* Previously received 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
* With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
* Inability to swallow, chronic diarrhea, intestinal obstruction, and a variety of factors affecting drug administration and absorption
* Participated in other drug clinical trials within 4 weeks before enrollment
* History of allergies to the drug components of this protocol
* Clinically significant pulmonary diseases
* Clinically significant cardiovascular diseases
* History of immunodeficiency
* Active hepatitis and liver cirrhosis

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: