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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Biopsies, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how breast cancer cells use energy. It is for people with early-stage breast cancer that is hormone receptor positive (HR+) and HER2 negative who plan to have surgery.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A biopsy (tissue sample) showed HR-positive, HER2-negative breast cancer. This means the cancer has receptors for estrogen, progesterone, or both, but is HER2 negative.
  • Have stage I, II, or III breast cancer with one of these tumor and lymph node stage codes: cT1cN0, cT1cN1, cT2N0, cT2N1, or cT3N0.
  • Plan to have surgery to remove the cancer with the goal of a cure. Have not had hormone therapy, chemotherapy, or chemotherapy with immunotherapy before surgery.
  • Agree to research samples of the tumor and normal tissue during surgery. These include small pieces cut out and samples taken with 4–6 needle passes.

Who can't join

  • Are in, or plan to join, another study that gives experimental treatments or procedures while taking part in this study.
  • Have triple-negative breast cancer (no estrogen, progesterone, or HER2 receptors) or HER2-positive breast cancer.
  • Have another active cancer.
  • Could become pregnant and have not had a recent negative pregnancy test outside this study as part of usual cancer care.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (2)

NJ