NCT04659499

Brief Summary

This is a multicenter, open-label, single-arm, prospective, phase II study. conducted to evaluate the efficacy, safety and tolerability of nab-paclitaxel plus pyrotinib in patients with lymph node-negative and tumor size ≤3 cm, HER2 positive breast cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
261

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2021

Typical duration for phase_2

Status
unknown

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

First Submitted

Initial submission to the registry

December 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 9, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

December 2, 2020

Last Update Submit

December 2, 2020

Conditions

Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 3-year-DFS

    3-years-disease free survival rate

    From the start of treatment to 3 years

Secondary Outcomes (1)

  • AEs+SAEs

    from the first drug administration to within 28 days for the last pyrotinib dose

Study Arms (1)

Nab-paclitaxel in combination with pyrotinib treatment group

EXPERIMENTAL

Nab-paclitaxel 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib 240mg daily for one year

Drug: Nab-paclitaxel in combination with pyrotinib

Interventions

Nab-paclitaxel in combination with pyrotinibDRUG

Nab-paclitaxel I.V. 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib oral 240mg daily for one year

Nab-paclitaxel in combination with pyrotinib treatment group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrollment subjects must have a pathological diagnosis of HER2-positive primary invasive breast cancer with an immunohistochemistry (IHC) score of 3 +, or 2 + and HER2 gene amplification by in situ hybridization (ISH) (ratio of HER2/CEP17 ≥ 2.0).
  • The invasive tumor had to measure no more than 3cm and with histologically confirmed lymph node-negative or one lymph node micrometastasis (T ≤ 3 cm, N0/N1mi, M0).
  • Tumor should has known ER/PR hormone receptor status.
  • All patients must be women above18 years old with Eastern Cooperative Oncology Group score 0 to 1.
  • Adequate hematopoietic function and organ function as defined as follows: neutrophil count ≥ 1.5 x 109/L; Platelet count ≥ 90 × 109/L; Hemoglobin ≥ 90 g/L; total bilirubin ≤ 1.5 × ULN; alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 × ULN; serum creatinine Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula).
  • left ventricular ejection fraction (LVEF) ≥ 50% and Electrocardiogram Fridericia-corrected QT interval (QTcF) ≤ 480 ms.
  • Provide written informed consent.

You may not qualify if:

  • Clinical or radiologic evidence of local or regional recurrence of disease or metastatic disease prior to or at the time of study entry.
  • Previous treatment with chemotherapeutic drugs, or tyrosine kinase inhibitors targeting HER2 (lapatinib, neratinib or pyrotinib, etc.).
  • Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
  • Inability to swallow, chronic diarrhea, or intestinal obstruction.
  • Known to be allergic to the drug components.
  • Have a history of immunodeficiency, including HIV positive, HCV positive, active viral hepatitis B or other immunodeficiency diseases.
  • Have a history of organ transplantation.
  • Pregnant, lactating female patients, or female patients who are unwilling to take effective contraceptive.
  • Any heart disease, including: (1) arrhythmia; (2) myocardial infarction; (3) heart failure.
  • Any other concomitant diseases assessed by investigator as unsuitable for study.
  • Previous history of definite neurological or psychiatric disorders.
  • Concomitant use of CYP3A4 inhibitors or inducers or drugs that prolong the QT interval.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wang C, Zhou Y, Lin Y, Mao F, Guan J, Zhang X, Shen S, Wang X, Zhang Y, Pan B, Zhong Y, Peng L, Cao X, Yao R, Zhou X, Xu C, Xu Y, Sun Q. Rationale and design of a phase II trial of pyrotinib in combination with nab-paclitaxel as adjuvant therapy for N0/N1mi, HER2 + early breast cancer (PHAEDRA). BMC Cancer. 2022 Mar 14;22(1):269. doi: 10.1186/s12885-022-09346-1.

    PMID: 35287613DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxelpyrotinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Qiang Sun, MD

CONTACT

+861069152700sunqiangpumc@sina.com

Changjun Wang, MD

CONTACT

+861069158721wangchangjun@pumch.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 9, 2020

Study Start

January 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2025

Last Updated

December 9, 2020

Record last verified: 2020-11