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A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER+/HER2+ Breast Cancer.

NCT04236310 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2020-01-22

No results posted yet for this study

Summary

To evaluate the efficacy and safety of the SHR6390 in combination with anastrozole, pyrotinib, and trastuzumab in patients with ER-positive, HER2-positive breast cancer in the neoadjuvant setting.

Conditions

Interventions

DRUG

SHR6390

SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment for 4 cycles

DRUG

Anastrozole

Anastrozole 1md, orally once daily for 16 weeks (For premenopausal women, ovarian suppression may be considered)

DRUG

Pyrotinib

Pyrotinib 400mg once daily for 16 weeks

DRUG

Trastuzumab

Trastuzumab 6mg/kg (loading dose, 8mg/kg), infusion once every 3-week cycle for 5 cycles.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Ruijin Hospital

    lead OTHER

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
2020-01-15
Primary Completion
2022-12-31
Completion
2022-12-31

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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 NCT04236310 on ClinicalTrials.gov