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Neoadjuvant With Trastuzumab, Pyrotinib Plus Palbociclib and Fulvestrant in HER2-positive, ER-positive Breast Cancer

NCT05076695 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-10-13

No results posted yet for this study

Summary

This is a prospective Single-arm Study to Investigate the Efficacy and Safety of Neoadjuvant treatment with trastuzumab and pyrotinib plus palbociclib and fulvestrant in HER2-positive, ER-positive breast cancer.

Conditions

Interventions

DRUG

Palbociclib

Palbociclib will be given at the dose of 125 mg po q.d. x 21 every 4 weeks (i.e. 1 week rest period for a total of 5 cycles)

DRUG

trastuzumab

8 mg/kg loading dose IV, then 6 mg/kg IV, every 3 weeks for a total of 6 administrations.

DRUG

pyrotinib

Pyrotinib 400mg, PO daily, continuously

DRUG

fulvestrant

Fulvestrant will be administered according to local prescription guidelines and will be given intramuscle at the dose of 500 mg every 4 weeks (repeat for 5 times) with an additional 500 mg dose given two weeks after the initial dose.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • zhimin U Shao, professor · Fudan University Shanghai Cancer Center Shanghai, China, 200032

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2023-10-15
Completion
2024-10-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05076695 on ClinicalTrials.gov