Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer

Last updated: April 14, 2024
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Cancer

Treatment

Pyrotinib, trastuzumab, paclitaxel-albumin

Clinical Study ID

NCT05659056
NJMU-BC01
  • Ages 18-75
  • Female

Study Summary

Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. female patients, 18 years ≤ age ≤ 75 years；
  2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
  3. Histologically confirmed invasive breast cancer（early stage or locally advanced）
  4. HER2 positive (HER2+++ by IHC or FISH+), and the HER2-enriched subtype screened byBulePrint test;
  5. Primary breast cancer;
  6. Known hormone receptor status.
  7. The organs are functioning normally, like the liver function, the renal function， andthe baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
  8. Signed informed consent form (ICF)

Exclusion

Exclusion Criteria:

  1. metastatic disease (Stage IV) or inflammatory breast cancer
  2. Previous or current history of malignant neoplasms, except for curativelytreated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
  3. Clinically relevant cardiovascular disease:Known history of uncontrolled orsymptomatic 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

Study Design

Total Participants: 65
Treatment Group(s): 1
Primary Treatment: Pyrotinib, trastuzumab, paclitaxel-albumin
Phase: 2
Study Start date:
November 29, 2022
Estimated Completion Date:
July 31, 2024

Connect with a study center

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

    Nanjing, Jiangsu
    China

    Active - Recruiting

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