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Trial Title:
Investigating the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer
NCT ID:
NCT05736367
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Hormone Receptor Positive
Metabolic activity
Breast Cancer Surgery
13C isotope glucose
Metabolomics
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
U-13C-glucose
Description:
Discover new insights into the glucose, TCA cycle, amino acid, and lipid metabolic
dependencies of HR+/Her2- breast cancer, via liquid chromatography-mass spectrometry
(LC-MS) and nuclear magnetic resonance (NMR) spectroscopy analysis of in vivo
U-13C-glucose-labeled biopsy of tumor and benign adjacent tissue
Arm group label:
Metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer
Summary:
To analyze the metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative
(Her2-) Breast cancer.
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.
Criteria for eligibility:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Contact:
Last name:
Coral Omene, MD,PhD
Phone:
732-235-3374
Email:
co273@cinj.rutgers.edu
Contact backup:
Last name:
Shridar Ganesan, MD,PhD
Phone:
732-235-3374
Email:
ganesash@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Contact:
Last name:
Coral Omene, MD, PhD
Phone:
732-235-3374
Email:
co273@cinj.rutgers.edu
Contact backup:
Last name:
Shridar Ganesan, MD,PhD
Phone:
732-235-3374
Email:
ganesash@cinj.rutgers.edu
Start date:
April 15, 2024
Completion date:
June 30, 2028
Lead sponsor:
Agency:
Rutgers, The State University of New Jersey
Agency class:
Other
Collaborator:
Agency:
Ludwig Institute for Cancer Research
Agency class:
Other
Source:
Rutgers, The State University of New Jersey
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05736367
