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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HER2-positive Breast Cancer
• Intervention / Treatment: Drug: Pyrotinib

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoan Liu, Professor; Phone Number: 025-68308162; Email: liuxiaoan@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
      • Contact: Xiaoan Liu, Professor; Phone Number: 025-68308162; Email: liuxiaoan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects voluntarily participate in this study and sign the informed consent form；
2. Female or male patients, aged ≥ 18 years, and ≤75 years;
3. ECOG PS score: 0-1;
4. 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).
5. Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery.
6. Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1.
7. Could have been treated neoadjuvantly but have not reached pathologic complete response.

Exclusion Criteria:

1. metastatic disease (Stage IV) or inflammatory breast cancer
2. 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.
3. Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
4. A history of allergy to the drugs in this study；
5. Unable or unwilling to swallow tablets
6. History of gastrointestinal disease with diarrhea as the major symptom.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pyrotinib; pyrotinib 400mg orally daily for one year	Drug: Pyrotinib; Pyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1）; Other Names: Pyrotinib maleate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive Disease-free Survival (iDFS) at year 2	Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.	From enrollment until time of events up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival at year 2 (2y-DFS)	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.	From enrollment until time of events up to 2 years
Overall Survival (OS)	Randomization to death from any cause	Enrollment until death due to any cause, up to 10 years
Invasive Disease-free Survival (iDFS) at year 5	Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.	From enrollment until time of events up to 5 years
AEs and SAEs	Adverse events and Adverse events and serious adverse events according to CACTE 5.0	From the first administration to one months after the last drug administration

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Xiaoan Liu, Professor, JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2023
• Primary Completion (Anticipated): June 1, 2026
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Maleic acid
• Other Study ID Numbers: OBU-BC-II-083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No