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Exploring Whether Disease-free Intervals Can Guide Endocrine Combined Targeted Therapy for ER+/HER2+ Advanced Breast Cancer (T-sunflower)

NCT05577923 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2022-10-13

No results posted yet for this study

Summary

This study is a prospective, single-arm, phase II clinical study for patients with ER+/HER2+ advanced breast cancer.

Conditions

Interventions

DRUG

Trastuzumab

8 mg/kg loading dose IV, then 6 mg/kg IV, every 3 weeks

DRUG

pyrotinib

Pyrotinib 320mg, PO daily, continuously

DRUG

Dalpiciclib

Dalpiciclib will be given at the dose of 125 mg po q.d. x 21 every 4 weeks

DRUG

fulvestrant

Fulvestrant will be given intramuscle at the dose of 500 mg every 4 weeks (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
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-09-01
Completion
2026-03-01

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 NCT05577923 on ClinicalTrials.gov