NCT05841381

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
876

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
85mo left

Started May 2023

Longer than P75 for phase_3 breast-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
May 2023May 2033

First Submitted

Initial submission to the registry

April 22, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

May 6, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2028

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2033

Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

5 years

First QC Date

April 22, 2023

Last Update Submit

April 22, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    5 year

Secondary Outcomes (3)

  • distant recurrence free survival

    5 year

  • overall survival

    5 year

  • adverse effects

    5 year

Study Arms (2)

arm 1

EXPERIMENTAL

Pyrotinib Plus trastuzumab and paclitaxel

Drug: PyrotinibDrug: TrastuzumabDrug: Paclitaxel

arm 2

ACTIVE COMPARATOR

trastuzumab and paclitaxel

Drug: TrastuzumabDrug: Paclitaxel

Interventions

PyrotinibDRUG

pyrotinib: 400mg orally daily for 1 year

arm 1
TrastuzumabDRUG

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

arm 1arm 2
PaclitaxelDRUG

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

arm 1arm 2

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinibTrastuzumabPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

Zhimin Shao, M.D.

CONTACT

+86-021-64175590zhimingshao@yahoo.com

Min He, M.D.

CONTACT

+86-021-64175590minsmiler@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 22, 2023

First Posted

May 3, 2023

Study Start

May 6, 2023

Primary Completion (Estimated)

May 6, 2028

Study Completion (Estimated)

May 6, 2033

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share