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New treatment option for Breast Cancer
Official title ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy
ClinicalTrials.gov ID: NCT06185205
What this study is testing
What is Accelerated partial breast irradiation?
Accelerated partial breast irradiation is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to compare any good and bad effects of giving radiation treatment for breast cancer in 3 treatments over about 2 days.
- 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 45 to 79, women only
You may be able to join if
- Female
- New diagnosis of ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
- Age 45-79 at diagnosis
- Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist.
- T stage of Tis, T1, or T2.
You likely can't join if
- Pregnant or breastfeeding
- Active collagen-vascular disease
- Paget's disease of the breast
- History of DCIS or invasive breast cancer prior to the current diagnosis
- Prior breast or thoracic radiation therapy (RT) for any condition
- Multicentric carcinoma (DCIS or invasive)
See the full eligibility criteria
- Female
- New diagnosis of ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
- Age 45-79 at diagnosis
- Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist.
- T stage of Tis, T1, or T2.
- T2 tumors must be ≤3 cm in maximum diameter
- If the tumor is human epidermal growth factor receptor 2 (HER2)-positive, the patient must receive HER2-directed therapy.
- For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection [with a minimum of 6 axillary nodes removed]) and the axillary node(s)...
- Note: N0(i+) is not an exclusion criterion.
- Note: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure:
- ≥70 years of age
- estrogen receptor, Her2 = human epidermal growth factor receptor 2, PR = progesterone receptor negative (ER+PR+HER2-)
- G1-2
- Tumor ≤2 cm in size
- Agrees to comply with aromatase inhibitor recommendation
- Ability to understand and the willingness to sign a written informed consent document in English
- Pregnant or breastfeeding
- Active collagen-vascular disease
- Paget's disease of the breast
- History of DCIS or invasive breast cancer prior to the current diagnosis
- Prior breast or thoracic radiation therapy (RT) for any condition
- Multicentric carcinoma (DCIS or invasive)
- Synchronous bilateral invasive or non-invasive breast cancer
- Surgical margins that cannot be microscopically assessed or that are positive
- Excision cavity that cannot be clearly delineated per the treating investigator
- Any of the dosimetric treatment criteria defined in Section 6.1 have not been met. Patients who become ineligible due to inability to meet dosimetric criteria should not receive treatment as - defined in this protocol...
- Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 45 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, 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.