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Predicted Biomarkers of CDK4/6 Inhibitors (Palbociclib) in ER-positive Metastasis Breast Cancer

NCT04289974 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-02-28

No results posted yet for this study

Summary

This is a multi-center, observational study designed to explore the regulatory mechanism of palbociclib correlative pathways in therapeutic process of breast cancer, employing next generation sequencing (NGS) on DNA and RNA. This study also monitor the clonal evolution of genes by tracing the ctDNA.

Conditions

Interventions

DRUG

Palbociclib

Palbociclib (125 mg PO qDay for Days 1-21 of each 28-day cycle) combined with Fulvestrant (500 mg IM on Days 1, 15, and 29, and then once monthly thereafter)

Sponsors & Collaborators

  • OrigiMed

    collaborator INDUSTRY

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Binghe Xu, PHD · Chinese Academy of Medical Sciences

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2020-06-30
Completion
2022-04-30
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 NCT04289974 on ClinicalTrials.gov