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NCT Number: NCT05635487

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

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.

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Key information

Conditions

HER2-positive Breast Cancer

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

Cai-Gang Liu, MD

PRINCIPAL_INVESTIGATOR

Nan Niu, MD

CONTACT

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 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

Treatment and study plan

SHR-A1811

Drug

SHR-A1811

Pyrotinib

Drug

Pyrotinib

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 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

Important dates

Study start
2023
Primary completion
2025
Study completion
2030
First posted
Dec 2, 2022
Registry last updated
Jul 5, 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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