RECRUITING

Investigating the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer

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Conditions

Breast CancerHormone Receptor PositiveMetabolic activityBreast Cancer Surgery13C isotope glucoseMetabolomics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To analyze the metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer.

Official Title

Pilot Study to Investigate the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer

Quick Facts

Study Start:2024-11-15
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05736367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have hormone receptor (HR) positive \[estrogen receptor( ER)+/progesterone receptor (PR)+, ER+/PR- or ER-/PR+)/Her2 negative breast cancer previously diagnosed by biopsy.
  2. * Have early stage, clinical or anatomic stage I, II or III breast cancer (cT1cN0, cT1cN1, cT2N0, cT2N1, cT3N0)
  3. * Candidates for intended curative primary resection who have not had neoadjuvant therapy (endocrine/hormonal therapy, chemotherapy with or without immunotherapy).
  4. * Willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed surgical resection.
  1. * Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study.
  2. * Has triple negative (ER-/PR-/Her2-) or HER2+ breast cancer.
  3. * Concomitant active malignancy
  4. * Is of child-bearing potential who has not had a recent negative pregnancy test done outside of this clinical trial (i.e., as part of standard preparation for diagnosis and treatment for her cancer)

Contacts and Locations

Study Contact

Coral Omene, MD, PhD
CONTACT
732-235-3374
co273@cinj.rutgers.edu
Shridar Ganesan, MD, PhD
CONTACT
732-235-3374
ganesash@cinj.rutgers.edu

Principal Investigator

Coral Omene, MD, PhD
PRINCIPAL_INVESTIGATOR
Cancer Institute of New Jersey Rutgers

Study Locations (Sites)

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
RWJBarnabas Health
New Brunswick, New Jersey, 08903
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Coral Omene, MD, PhD, PRINCIPAL_INVESTIGATOR, Cancer Institute of New Jersey Rutgers

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-15
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2024-11-15
Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

  • Hormone Receptor Positive
  • Metabolic activity
  • Breast Cancer Surgery
  • 13C isotope glucose
  • Metabolomics

Additional Relevant MeSH Terms

  • Breast Cancer