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A Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

Sponsor
Shengjing Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05635487
Collaborator
Jiangsu HengRui Medicine Co., Ltd. (Industry)
61
Enrollment
1
Location
1
Arm
72
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-arm, phase II trial evaluating the efficacy and safety of SHR-A1811 combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 and pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
61 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-arm, Phase II Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Anticipated Study Start Date :
Nov 30, 2022
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHR-A1811+Pyrotinib

Drug: SHR-A1811
SHR-A1811

Drug: Pyrotinib
Pyrotinib

Outcome Measures

Primary Outcome Measures

  1. Total pathological complete response (tpCR: ypT0-is/ypN0) [At the time of surgery]

Secondary Outcome Measures

  1. Breast pathological complete response (bpCR：ypT0-is) [At the time of surgery]

  2. Residual cancer burden (RCB) [At the time of surgery]

  3. Best overall response rate (BORR) [During 18 weeks of the neoadjuvant treatment]

  4. Overall survival (OS) [5 years]

  5. Disease-free survival (DFS) [5 years]

  6. Event-free survival (EFS) [5 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shengjing Hospital affiliated to China Medical University Shenyang Liaoning China 110004

Sponsors and Collaborators

  • Shengjing Hospital
  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Caigang Liu, MD, Shengjing Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Caigang Liu, Director of the Cancer Center, Shengjing Hospital
ClinicalTrials.gov Identifier:
NCT05635487
Other Study ID Numbers:
  • MUKDEN 07
First Posted:
Dec 2, 2022
Last Update Posted:
Dec 2, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Caigang Liu, Director of the Cancer Center, Shengjing Hospital
SHR-A1811
Pyrotinib
HER2-positive Breast Cancer
Neoadjuvant
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Dec 2, 2022