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New treatment option for Breast Cancer
Official title 5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
ClinicalTrials.gov ID: NCT06961955
What this study is testing
- What it's testing
- The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female participant aged ≥ 18 years. --Participants must have at least one of the following risk factors:
- Grade 3 invasive histology
- Estrogen receptor positivity less than 5%
- Lymphovascular invasion
- Invasive margins \<2mm on surgical pathology
You likely can't join if
- Bilateral breast cancer.
- Prior radiation therapy to the chest.
- Prior chemotherapy.
- Recurrent disease.
- Known metastases or node positive.
- Major chest surgery which is expected to impact study participation 8 weeks prior to starting study drug.
See the full eligibility criteria
- Female participant aged ≥ 18 years. --Participants must have at least one of the following risk factors:
- Grade 3 invasive histology
- Estrogen receptor positivity less than 5%
- Lymphovascular invasion
- Invasive margins \<2mm on surgical pathology
- DCIS final positive margin
- Extensive intraductal component
- Age ≤ 50 years
- Tumor size \> 2 cm
- Histologically confirmed invasive carcinoma or Ductal Carcinoma In Situ (DCIS) of the breast.
- Breast cancer stage (AJCC v8) T0-3, N0, M0. T0 N0 is allowed if whole breast radiation is recommended by the treating physician.
- Lumpectomy within 84 days of the start of radiation.
- ECOG Performance Status ≤ 2, or KPS ≥ 50
- Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia.
- Negative pregnancy test for participants of childbearing potential, evidence of permanent surgical sterilization, or post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12...
- \< 50 years of age:
- Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
- ≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- Had radiation-induced menopause with last menses \>1 year ago; or
- Had chemotherapy-induced menopause with last menses \>1 year ago
- Sexually active participants of childbearing potential must agree to use highly effective method of contraception (defined in Section 5.4.1) during the course of radiation and for 30 days after radiation.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- Bilateral breast cancer.
- Prior radiation therapy to the chest.
- Prior chemotherapy.
- Recurrent disease.
- Known metastases or node positive.
- Major chest surgery which is expected to impact study participation 8 weeks prior to starting study drug.
- Prior breast malignancy in either breast.
- The diagnosis of any other malignancy which, in the opinion of the Investigator, is likely to negatively impact the subject's safety or ability to participate in the study.
- Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
- Cardiovascular disorders:
- Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
- Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
- Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g...
- Significant post lumpectomy complications requiring an unplanned re-operation for surgical complications or admission for IV antibiotics. Re-operation for margins evaluation or nodal evaluation is acceptable. Draining...
- Breast neuroendocrine carcinoma or sarcoma histology.
- Radiation sensitizing disease or condition (e.g. connective tissue disease, li fremani, etc.).
- Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
- Participants receiving concurrent radiation sensitizing medications or therapies.
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.