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NCT Number: NCT05834764

Pyrotinib in Women With High-risk in Early Stage Breast Cancer

ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached.

However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.

Recruiting

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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

JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Xiaoan Liu, Professor

CONTACT

[email protected]

025-68308162

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects voluntarily participate in this study and sign the informed consent form；
  • Female or male patients, aged ≥ 18 years, and ≤75 years;
  • ECOG PS score: 0-1;
  • Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH).
  • Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery.
  • Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1.
  • Could have been treated neoadjuvantly but have not reached pathologic complete response.

Exclusion criteria

  • metastatic disease (Stage IV) or inflammatory breast cancer
  • Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
  • Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
  • A history of allergy to the drugs in this study；
  • Unable or unwilling to swallow tablets
  • History of gastrointestinal disease with diarrhea as the major symptom.

Treatment and study plan

Pyrotinib

Drug

Pyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1）

Other names: Pyrotinib maleate

Primary outcomes

  1. Invasive Disease-free Survival (iDFS) at year 2

    Time frame: From enrollment until time of events up to 2 years

    Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.

Secondary outcomes

  1. Disease-free Survival at year 2 (2y-DFS)

    Time frame: From enrollment until time of events up to 2 years

    Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause.

  2. Overall Survival (OS)

    Time frame: Enrollment until death due to any cause, up to 10 years

    Randomization to death from any cause

  3. Invasive Disease-free Survival (iDFS) at year 5

    Time frame: From enrollment until time of events up to 5 years

    Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.

  4. AEs and SAEs

    Time frame: From the first administration to one months after the last drug administration

    Adverse events and Adverse events and serious adverse events according to CACTE 5.0

Study contacts

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

Xiaoan Liu, Professor

CONTACT

[email protected]

025-68308162

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Registry information

Official study title

Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Apr 28, 2023
Registry last updated
Apr 28, 2023

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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