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Effects of Ribociclib and Palbociclib on Tumor and Blood Characteristics in Patients With Metastatic Breast Cancer

NCT05244434 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-06-09

No results posted yet for this study

Summary

This clinical trial attempts to understand the differences between two chemotherapy drugs, ribociclib and palbociclib, and how they fight cancer. This study looks at tissue and blood characteristics of patients receiving these therapies in the hopes to develop a way to predict which medication would provide the most benefit to an individual patient.

Conditions

  • Advanced Breast Adenocarcinoma
  • Advanced HER2-Negative Breast Carcinoma
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Hormone Receptor-Positive Breast Carcinoma
  • Metastatic Breast Adenocarcinoma
  • Metastatic HER2-Negative Breast Carcinoma
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Prognostic Stage IV Breast Cancer AJCC v8

Interventions

OTHER

Best Practice

Given standard of care ribociclib + AI or palbociclib + AI

PROCEDURE

Biopsy

Undergo biopsy of tumor tissue

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Laboratory Biomarker Analysis

Undergo analysis of previously collected tumor tissue

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Yuan Yuan · City of Hope Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-03
Primary Completion
2023-01-26
Completion
2023-01-26

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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 NCT05244434 on ClinicalTrials.gov