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New treatment option for Anatomic Stage I Breast Cancer AJCC v8
Official title Ultra-hypofractionated Whole Breast Irradiation With Lumpectomy Cavity Boost for the Treatment of Stage I-III Breast Cancer
ClinicalTrials.gov ID: NCT06954831
What this study is testing
- What it's testing
- This clinical trial tests how well ultra-hypofractionated (UF) whole breast irradiation (WBI) with lumpectomy cavity boost (CB) works in treating patients with stage I-III breast cancer. Breast conservation therapy (BCT) is the recommended treatment for patients with early stage breast cancer.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, women only
You may be able to join if
- Documented informed consent of the participant and/or legally authorized representative
- Age: ≥ 40 years
- Female
- Ability to read and understand English for questionnaires
- Histologically confirmed breast cancer
You likely can't join if
- Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude breast irradiation
- Pathologically or clinically involved regional lymph nodes necessitating comprehensive regional nodal irradiation that includes the supraclavicular...
- Clinically significant uncontrolled illness
- Stage IV breast cancer
- Diagnosis of Paget's disease of the nipple
- Other prior or active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to...
See the full eligibility criteria
- Documented informed consent of the participant and/or legally authorized representative
- Age: ≥ 40 years
- Female
- Ability to read and understand English for questionnaires
- Histologically confirmed breast cancer
- Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed
- Patients must have undergone breast conserving surgery. Re-excision for negative margins is allowed
- Patients must have undergone surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph node dissection)
- Must have at least one-high risk feature that would necessitate a lumpectomy cavity boost by the treating radiation oncologist
- Patient must have physician-reported "Excellent" or "Good" cosmesis post-lumpectomy and prior to radiation therapy based on the 4-point Global Cosmetic Score
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
- Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude breast irradiation
- Pathologically or clinically involved regional lymph nodes necessitating comprehensive regional nodal irradiation that includes the supraclavicular fossa
- Clinically significant uncontrolled illness
- Stage IV breast cancer
- Diagnosis of Paget's disease of the nipple
- Other prior or active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the...
- Pregnant or breastfeeding
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
The study team makes the final eligibility decision.
Where it's taking place
- Arcadia, California, United States
- Duarte, California, United States
- Irvine, California, United States
- Lancaster, California, United States
- South Pasadena, California, United States
- Torrance, California, United States
- Upland, California, 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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arcadia, California, United States; Duarte, California, United States; Irvine, California, United States; Lancaster, California, United States; South Pasadena, California, United States; Torrance, California, United States and 1 more location(s). 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.