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Adjuvant Study of Pyrotinib in Combination With Trastuzumab in HER2 Positive Invasive Breast Cancer

Sponsor
Fudan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05841381
Collaborator
(none)
876
Enrollment
2
Arms
120
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is an open label, phase III study evaluating the efficacy and safety of Pyrotinib in Combination With Trastuzumab and paclitaxel in patients HER2 Positive and lymph node negative invasive Breast Cancer

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
876 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive and Lymph Node Negative Invasive Breast Cancer
Anticipated Study Start Date :
May 6, 2023
Anticipated Primary Completion Date :
May 6, 2028
Anticipated Study Completion Date :
May 6, 2033

Arms and Interventions

Arm Intervention/Treatment
Experimental: arm 1

Pyrotinib Plus trastuzumab and paclitaxel

Drug: Pyrotinib
pyrotinib: 400mg orally daily for 1 year

Drug: Trastuzumab
8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 17 cycles

Drug: Paclitaxel
80mg/m2 per week for a total of 12 weeks
Active Comparator: arm 2

trastuzumab and paclitaxel

Drug: Trastuzumab
8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 17 cycles

Drug: Paclitaxel
80mg/m2 per week for a total of 12 weeks

Outcome Measures

Primary Outcome Measures

  1. Disease free survival [5 year]

Secondary Outcome Measures

  1. distant recurrence free survival [5 year]

  2. overall survival [5 year]

  3. adverse effects [5 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Females 18-70 years old;

  • Pathological confirmed of stage I-II breast cancer: histologically confirmed that the longest diameter of invasive cancer is no less than 1cm and no more than 5cm and the lymph node is negative (N0);

  • The pathological type of immunohistochemistry must meet the following conditions: HER-2 (3+) or HER-2 (0-2 +) with FISH detection is amplified;

  • For patients with invasive lesions on both sides, if both lesions are HER-2 positive and meet the tumor size requirements, then can be enrolled;

  • Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN#and with endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula);

  • LVEF>50%;

  • The patient voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

Exclusion Criteria:

  • Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy;

  • Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ;

  • Has metastic (Stage 4) breast cancer;

  • Pregnant or breast feeding women, or women of childbearing age who cannot practice effective contraceptives;

  • Patients participating in other clinical trials at the same time;

  • Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmHg, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;

  • Has severe or uncontrolled infection;

  • Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;

  • The researchers considered patients to be unsuitable for the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhimin Shao, professor, Fudan University
ClinicalTrials.gov Identifier:
NCT05841381
Other Study ID Numbers:
  • SCHBCC
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Breast Neoplasms
Paclitaxel
Trastuzumab

Study Results

No Results Posted as of May 3, 2023