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Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy

NCT03281902 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2025-03-06

No results posted yet for this study

Summary

This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and endocrine therapy. Examining the genetic changes associated with the cancer and comparing the genetic material from the cancer tissue with the genetic material found in the blood may help doctors to develop customized treatment for breast cancer.

Conditions

  • Advanced Breast Carcinoma
  • Locally Advanced Breast Carcinoma
  • Metastatic Breast Carcinoma
  • Recurrent Breast Carcinoma
  • Stage III Breast Cancer AJCC v7
  • Stage IIIA Breast Cancer AJCC v7
  • Stage IIIB Breast Cancer AJCC v7
  • Stage IIIC Breast Cancer AJCC v7
  • Stage IV Breast Cancer AJCC v6 and v7

Interventions

PROCEDURE

Biopsy

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood, urine, stool, and saliva

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Ciara O'Sullivan, M.B., B.Ch. · Mayo Clinic in Rochester

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-13
Primary Completion
2026-03-04
Completion
2026-03-04

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03281902 on ClinicalTrials.gov