NCT04917900

Single-arm, Multi-center Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin-bound Paclitaxel and Trastuzumab in Neoadjuvant Treatment of Her2-positive Early or Locally Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate the Pyrotinib in combination with albumin-bound paclitaxel and trastuzumab to neoadjuvant therapy efficacy and safety of Her2-positive early or locally advanced breast cancer

Detailed description

Subjects who met the criteria for admission were treated with pyrotinib combined with albumin-bound paclitaxel and trastuzumab (q3w) neoadjuvant therapy for 6 cycles before surgery, and DCR and ORR were assessed before surgery.All subjects who are suitable for surgery undergo surgery and evaluate their pCR rate (pathological complete remission rate).After the operation, the subjects received adjuvant chemotherapy of epirubicin hydrochloride + cyclophosphamide (q3w) for 4 cycles, and at the same time, according to the researcher's recommendation, they chose the follow-up anti-HER2 treatment plan: it is recommended that subjects who have achieved pCR receive preoperative the same anti-Her2 treatment for 1 year; for non-pCR subjects, T-DM1 or trastuzumab and Pertuzumab can be used for anti-her2 treatment for 1 year.For subjects whose estrogen receptor (ER) and/or progesterone receptor (PR) are positive, endocrine therapy can be started at the end of adjuvant chemotherapy.If there are clinical indications at the end of adjuvant chemotherapy, radiotherapy can be given.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib combined with albumin-bound paclitaxel and trastuzumab	Pyrotinib: 400mg, po,qd,with warm water within 30 minutes after breakfast, q3weeks, 6 cycles in total. Albumin-bound paclitaxel: 260mg/m2, iv, Day1, q3weeks, 6 cycles in total. Trastuzumab: The first cycle dose is 8mg/kg, and each subsequent cycle is 6mg/kg, iv, Day 1, q3weeks, a total of 6 cycles.

Timeline

• Start date: 2020-12-01
• Primary completion: 2023-08-30
• Completion: 2023-12-31
• First posted: 2021-06-08
• Last updated: 2022-10-10

Locations

1 site across 1 country: China