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

NCT ID: NCT05834764

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-08

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HER2-positive Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pyrotinib

pyrotinib 400mg orally daily for one year

Group Type EXPERIMENTAL

Pyrotinib

Intervention Type DRUG

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

Interventions

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Pyrotinib

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

Intervention Type DRUG

Other Intervention Names

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Pyrotinib maleate

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Liu Xiaoan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoan Liu, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoan Liu, Professor

Role: CONTACT

Phone: 025-68308162

Email: [email protected]

Facility Contacts

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Xiaoan Liu, Professor

Role: primary

Other Identifiers

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OBU-BC-II-083

Identifier Type: -

Identifier Source: org_study_id