Adjuvant Dual Anti-HER2 Therapy in Patients With Tumors < 8mm, Node-negative, HER2-positive Breast Cancer :a Single-group Arm, Open-label, Prospective, Phase 2 Study

xuexin he0 sites60 target enrollmentJune 1, 2020

ConditionsHER2-positive Breast Cancer

InterventionsPyrotinib Trastuzumab

DrugsPyrotinib Trastuzumab

Overview

Phase: Phase 2
Intervention: Pyrotinib
Conditions: HER2-positive Breast Cancer
Sponsor: xuexin he
Enrollment: 60
Primary Endpoint: Disease-free Survival
Status: Not yet recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This phase II trial aims to study the efficacy and safety of adjuvant Pyrotinib plus trastuzumab in patients with tumors <8mm, node-negative, HER2-positive breast cancer.

Registry

clinicaltrials.gov

Start Date

June 1, 2020

End Date

May 31, 2030

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

xuexin he

Responsible Party

Sponsor Investigator

Principal Investigator

xuexin he

Associate chief physician

Second Affiliated Hospital, School of Medicine, Zhejiang University

Eligibility Criteria

Inclusion Criteria

•Women aged 18-70 years old
•Have finished radical operation
•Histologically confirmed invasive ductal carcinoma (IDCA)
•According to AJCC ,pT\<8mm, pN0, no evidence for metastasis
•Operation specimens are available for ER, progesterone receptor (PR) and HER2 detection, patients should be HER2 positive tumor (IHC staining of 3+ \[uniform, intense membrane staining of \>30% of invasive tumor cells\], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio \[HER2 gene signals to chromosome 17 signals\] of \>2.2), nuclear grade
•Should have tumor tissue available and sufficient for multi-spots sampling.
•It has been \<84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician.
•Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1, expected survival time \> 12 months
•Cardiac function had to be within normal limits (left ventricular ejection fraction \[LVEF\] ≥50%), as established by multiple gated acquisition scan or echocardiography.
•Adequate bone marrow function, adequate liver and renal function, and adequate coagulation function.

Exclusion Criteria

•pT≥8mm or node positive
•Metastatic breast cancer
•Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
•With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
•Patients with medical conditions that indicate intolerant to adjuvant target therapy and related treatment, including severe infection, coagulation disorder, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
•Has symptomatic peripheral neuropathy \> grade 2 according to NCI
•Known severe allergy to any drugs in this study
•Has cardiac dysfunction or lung dysfunction defined as follows:
•grade ≥3 CHF according to NCI CTCAE v 5.0 or NYHA≥II
•angina which requires drug control, cardiac infraction, and any other vascular disease with apparent clinical symptoms