Adjuvant Dual Anti-HER2 Therapy in Patients With Small, Node-negative, HER2-positive Breast Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
Sponsorxuexin he

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pyrotinib
  • Trastuzumab

Treatment groups

60 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

xuexin he

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor institution