Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Vinorelbine in Trastuzumab-refractory HER2-Positive Breast Cancer.

Sponsor
Henan Cancer Hospital
Study ID
NCT03947242
Status
Unknown

Conditions

  • HER2 Positive Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Pyrotinib and Trastuzumab plus Vinorelbine — DRUG
    Pyrotinib:400mg orally daily Trastuzumab:8mg/kg ivgtt load followed by 6mg/kg ivgtt 3-weekly for a total of 4 cycles Vinorelbine :25mg/m2 ivgtt 3-weekly for a total of 4 cycles,d1 d8

Study Details

This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus Vinorelbine given as neoadjuvant treatment in Trastuzumab-refractory HER2 positive early stage or locally advanced breast cancer.

Key Dates

Start date
Jun 1, 2019
Status verified
May 2019
Primary completion
Jun 1, 2020
Completion
Dec 30, 2020

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pyrotinib + trastuzumab +Vinorelbine
    Pyrotinib in Combination With Trastuzumab Plus Vinorelbine

Primary Outcome Measure

ORR [ Time Frame: [Time Frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months ]

Central Contacts