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RecruitingPhase 2

Ultra-hypofractionated Whole Breast Irradiation With Lumpectomy Cavity Boost for the Treatment of Stage I-III Breast Cancer

Phase 2 Trial of Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors."
  • "After completion of study treatment, patients are followed up at 1 month, 6 months, then annually for up to 5 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests breast radiation given over 5 daily treatments for women age 40 or older with stage I–III breast cancer after a lumpectomy, surgery to remove the tumor. It gives radiation to the whole breast and extra radiation to the area where the tumor was removed at the same time.

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. BCT involves a lumpectomy followed by breast radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Traditionally, WBI has been given once daily over 5-6 weeks and then those at high-risk for recurrence receive additional radiation (boost) to the lumpectomy cavity daily over 4-8 days. This has now been replaced by moderate hypofractionated radiation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Although moderate hypofractionated radiation therapy reduces the length of treatment from 6-7 weeks to 3-4 weeks, the length of treatment still remains a barrier for many patients. UF-WBI with CB delivers radiation to the whole breast and the surgical cavity at the same time over 5 daily treatments. Giving UF-WBI with CB may prevent recurrence and prolong survival as well as improve the quality of life in patients with stage I-III breast cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You or your legal representative must give written consent to join.
  • You must be female and age 40 or older.
  • You must be able to read and understand English to answer questionnaires.
  • A tissue test must confirm breast cancer that starts in lining cells, not lymphoma or sarcoma.
  • You must have had a lumpectomy and surgery to check lymph nodes in your armpit. A second surgery to remove remaining cancer at the edges is allowed.
  • You must have at least one high-risk feature that makes extra radiation to the tumor area needed, according to your radiation doctor.
  • Your doctor must rate how your breast looks after surgery and before radiation as “Excellent” or “Good.”
  • If you could become pregnant, you must have a negative pregnancy test. A blood test is needed if a urine test is positive or unclear.

Who can't join

  • You had radiation near the affected breast that your study doctor thinks makes more breast radiation unsafe.
  • Cancer in nearby lymph nodes requires radiation to a broad area of nodes, including those above the collarbone.
  • You have a serious illness that is not under control.
  • You have stage IV breast cancer, which has spread to distant parts of the body.
  • You have Paget’s disease of the nipple, a type of cancer affecting the nipple.
  • You have another current or past cancer, unless it and its treatment would not affect the study’s safety or results.
  • You are pregnant or breastfeeding.
  • Your study doctor thinks you may not be able to follow all study steps, including because of travel or scheduling problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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) Exclusion Criteria: * 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 efficacy assessment of the investigational regimen are eligible for this trial * 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)

Study sites (7)

CA