Genomically guided radiation therapy for triple negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the feasibility of using genomically guided radiation therapy in patients with triple negative breast cancer who have undergone breast conservation therapy. Participants will have their tumor's genomic profile assessed to tailor radiation treatment specifically to their cancer's characteristics. The study focuses on individuals who have had a lumpectomy and axillary evaluation, ensuring that the treatment is personalized based on the genomic data obtained from their tumors.

Why it matters

Who can join: the full rules

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

Where it's running

• Morton Plant Hospital - Baycare Health System
  Clearwater, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Kamran Ahmed, MD — Moffitt Cancer Center
• Study coordinator: Robin Dowell
• Email: Robin.Dowell@moffitt.org
• Phone: 813-745-0393

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.