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NCT05736367 | RECRUITING | Breast Cancer

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

Rutgers, The State University of New Jersey

Information provided by (Responsible Party):

Human coral

Brief Summary:

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

Condition or disease

Breast Cancer

Intervention/treatment

U-13C-glucose

Phase

NA

Detailed Description:

Participants will be asked to receive a glucose infusion (U-13C- glucose intravenous) during routine breast cancer surgery at which time, tumor biopsy samples and blood samples will be collected to be used in research experiments to help provide insight into the metabolic activity of the tumor. The length of time on study for each patient will be three - four weeks including two to three hours for glucose infusion and breast cancer biopsy.

Study Type : INTERVENTIONAL
Estimated Enrollment : 16 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Pilot Study to Investigate the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer
Actual Study Start Date : 2024-11-15
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2028-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Have hormone receptor (HR) positive \[estrogen receptor( ER)+/progesterone receptor (PR)+, ER+/PR- or ER-/PR+)/Her2 negative breast cancer previously diagnosed by biopsy.
  • * Have early stage, clinical or anatomic stage I, II or III breast cancer (cT1cN0, cT1cN1, cT2N0, cT2N1, cT3N0)
  • * Candidates for intended curative primary resection who have not had neoadjuvant therapy (endocrine/hormonal therapy, chemotherapy with or without immunotherapy).
  • * 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.
Exclusion Criteria
  • * 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.
  • * Has triple negative (ER-/PR-/Her2-) or HER2+ breast cancer.
  • * Concomitant active malignancy
  • * 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)
Investigating the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer

Location Details

NCT05736367

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08903

NOT YET RECRUITING

United States, New Jersey

RWJBarnabas Health

New Brunswick, New Jersey, United States, 08903