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

NCT05834764 | Recruiting Phase 2

• 1 other identifier: OBU-BC-II-083
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disease-free Survival at year 2 (2y-DFS)

  From enrollment until time of events up to 2 years

• Overall Survival (OS)

  Enrollment until death due to any cause, up to 10 years

• Invasive Disease-free Survival (iDFS) at year 5

  From enrollment until time of events up to 5 years

• AEs and SAEs

  From the first administration to one months after the last drug administration

Study Arms (1)

Pyrotinib

EXPERIMENTAL

pyrotinib 400mg orally daily for one year

Drug: Pyrotinib

Interventions

Pyrotinib DRUG

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

Also known as: Pyrotinib maleate

Pyrotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

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

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Interventions

pyrotinib

Study Officials

• Xiaoan Liu, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoan Liu, Professor

CONTACT

025-68308162; liuxiaoan@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 28, 2023
• Study Start: April 8, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)