Genomically guided radiation therapy for triple negative breast cancer
Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer
This study is testing if personalized radiation therapy based on the genetic makeup of triple negative breast cancer can improve treatment for patients who have had breast-conserving surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Clearwater, Florida and 1 other locations) |
| Trial ID | NCT05528133 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed triple negative breast cancer who have undergone breast conservation therapy.
Not a fit: Patients with non-triple negative breast cancer or those who have not had breast conservation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized radiation treatments for patients with triple negative breast cancer.
How similar studies have performed: Other studies have shown promise in using genomic data to guide cancer treatment, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clearwater, Florida and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.