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Palbociclib in Combination With Fulvestrant Versus Fulvestrant in Advanced Breast Cancer: A Real-world Study in China

NCT04526028 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 612

Last updated 2020-08-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate efficacy and safety of CDK4/6 inhibitor Palbociclib in combination with Fulvestrant versus Fulvestrant in female patients with HR+/HER2- advanced breast cancer in a real world setting in China. Primary study endpoint: progression-free survival (PFS). Secondary study endpoints: overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), objective response duration (DOR) and safety.

Conditions

Interventions

DRUG

Fulvestrant Injectable Product

Fulvestrant is in the form of a prefilled syringe containing 5 ml of an injection solution of 250 mg of fulvestrant for intramuscular injection. The recommended dose is once every 28 days, once at a dose of 500 mg, and on the 15th day after the initial injection, a loading dose of fulvestrant 500 mg is added.

DRUG

Palbociclib

Palbociclib is in the form of oral capsules, which are divided into three specifications: 75 mg, 100 mg and 125 mg. The recommended dose is 125 mg once daily for 21 days, followed by 7 days (3/1 dosage regimen), 28 Day is a treatment cycle.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-13
Primary Completion
2023-02-28
Completion
2023-05-31
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT04526028 on ClinicalTrials.gov