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RecruitingPhase 2

Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer

Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple 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

Not stated in the study description — ask the study team about visits and procedures.

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 tests whether gene information can help guide radiation treatment for triple-negative breast cancer. It is for adults who had surgery to remove the cancer while keeping the breast.

The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.

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

Eligibility

Who can join

  • Be age 18 or older.
  • Have had a lumpectomy (surgery to remove the breast tumor) and surgery to check or remove underarm lymph nodes.
  • Have triple-negative breast cancer confirmed by a tissue sample: no high HER2 level and hormone receptors in less than 10% of cells.
  • Have enough tumor tissue to calculate RSI, a score related to how the tumor responds to radiation.
  • Be expected to live more than 16 weeks and be able to care for yourself, even if you cannot do normal activities or work.
  • If surgery was within the past 14 days, have recovered from all its effects and have your surgeon's approval.
  • Women who can become pregnant and sexually active men must use effective birth control during the study.
  • Give informed consent before joining. A family member or health care proxy may sign the form.

Who can't join

  • Have not recovered from major surgery or a serious injury 14 days before starting the study.
  • Are pregnant or breastfeeding.
  • Have cancer cells at the edge of the tissue removed during surgery.
  • Have a history of allergy to any study drug or its ingredients.
  • Have breast cancer that has spread to distant parts of the body.

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

Official eligibility criteria

Inclusion Criteria: * Participants should have undergone breast conservation therapy with a lumpectomy and axillary evaluation to consist of a sentinel node biopsy or axillary dissection * Confirmation of Triple Negative (TN) breast cancer by tissue biopsy * Adequate tissue to calculate RSI * To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines * To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer must express (\<10%), by immunohistochemistry (IHC), the hormone receptors (estrogen receptor \[ER\] and progesterone receptor \[PR\]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines * Life expectancy \>16 weeks * KPS ≥ 70 * Age ≥ 18 years * Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon * There is no limit on prior systemic therapies * Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study * Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before study enrollment Exclusion Criteria: * Major surgery or significant traumatic injury that has not been recovered from 14 days before study initiation * Women who are pregnant or breastfeeding * Positive surgical margins * History of allergy or hypersensitivity to any of the study drugs or study drug components * Metastatic breast cancer

Study sites (2)

FL