NOT_YET_RECRUITING
Investigating the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer
To analyze the metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer.
Conditions:
🦠 Breast Cancer
🗓️ Study Start (Actual) 15 April 2024
🗓️ Primary Completion (Estimated) 30 June 2025
✅ Study Completion (Estimated) 30 June 2028
👥 Enrollment (Estimated) 16
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New Brunswick, New Jersey, United States
📍 New Brunswick, New Jersey, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 6 February 2023
  • First Submitted that Met QC Criteria 16 February 2023
  • First Posted 21 February 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 January 2024
  • Last Update Posted 10 January 2024
  • Last Verified January 2024