RECRUITING

Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer

Conditions

Node-positive Breast Cancer Breast cancer Radiation Hypofractionation QOL Cosmesis Toxicity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In breast cancer patients with nodal involvement, numerous studies have demonstrated that adjuvant radiation therapy reduces the risk of local recurrence, regional recurrence, and distant metastases, in addition to improving survival. The dose and fractionation for adjuvant breast radiation therapy has evolved over time, as novel schedules have been compared to the current standard of care. Hypofractionated radiation therapy (266 cGy per fraction x 15-16 fractions over 3 weeks) has been shown to result in equivalent oncologic outcomes, as well as equivalent acute and late toxicity, when compared to standard fractionation (200 cGy per fraction x 25 fractions over 5 weeks). Subsequently, hypofractionated breast radiation has become the current standard of care. More recently, ultra-hypofractionated breast radiation (520 cGy per fraction x 5 fractions over 1 week) was shown in a randomized trial to be non-inferior to hypofractionated radiation when treating the breast after lumpectomy. However, the efficacy and toxicity of using ultra-hypofractionated radiation therapy when also treating the regional nodes has not been reported. This is important, as there is greater radiation exposure to several normal tissues, such as the arm/shoulder, brachial plexus, normal lymphatics, heart, and lung, when treating the regional nodes. In this randomized study, the investigators aim to compare the tolerability and efficacy of ultra-hypofractionated breast/chest wall and regional nodal radiation (SWIFT RT) against hypofractionated radiation (RT). The investigators will evaluate acute and late toxicity, oncologic outcomes (including local recurrence, regional recurrence, distant metastasis, and overall survival), cosmesis, and patient-reported quality of life. The investigators will collect blood samples for correlative studies of biomarkers of fibrosis and cardiac toxicity.

Official Title

SWIFT RT: Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer

Quick Facts

Study Start:2024-08-27

Study Completion:2034-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06559540

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically confirmed invasive carcinoma of the breast. Metaplastic breast cancer is allowed. * AJCC 8th Edition Stage: cT1-3 primary tumor. cN1-2 or pN1-2. * Biopsy-proven involved axillary node(s) (either at baseline and/or at time of surgery). * Undergone either partial mastectomy (with negative final histologic margins (defined as no tumor on ink, after initial surgery or re-excision)) or mastectomy (with negative histologic margins defined as tumor (either invasive or in situ disease) \> 2 mm from the final margin). * Nodal surgery with either sentinel lymph node biopsy or axillary lymph node dissection. Effort to recover the original biopsy-proven node should be performed at time of surgery. * Systemic therapy (chemotherapy and/or endocrine therapy) should be administered as per standard of care and recommendation of medical oncology. Neoadjuvant and/or adjuvant systemic therapy is allowed. Concurrent endocrine therapy, anti-HER2 therapy, and immunotherapy during RT is allowed. * All radiation therapy must be planned to be delivered at BJH or a Siteman satellite location. * Female. * Age ≥ 18 years at diagnosis. * ECOG Zubrod performance status 0 or 1. * English speaker. * Able to understand and willing to sign IRB-approved written informed consent document.	* Presence of distant metastases. * Diagnosis of nonepithelial breast malignancies such as sarcoma or lymphoma. * Diagnosis of bilateral breast cancer. * AJCC cT4 disease, pT4 disease, or any skin involvement on exam or pathology, including dermal LVSI. * Presence of palpable or radiographically suspicious supraclavicular, infraclavicular, or internal mammary nodes. * Prior radiation therapy which would have any overlap with current radiation therapy plan. * Diagnosis of prior breast cancer or diagnosis of current breast cancer more than one year prior to enrollment. * Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis. * Diagnosis of a coexisting medical condition which limits life expectancy to \< 2 years. * Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational treatment. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial. * Time between last breast cancer therapy (either surgery or chemotherapy) to RT simulation is greater than 8 weeks. * Planning to undergo concurrent chemotherapy. * Pregnancy, which will be excluded prior to simulation.

Inclusion Criteria

Exclusion Criteria

* Histologically confirmed invasive carcinoma of the breast. Metaplastic breast cancer is allowed.
* AJCC 8th Edition Stage: cT1-3 primary tumor. cN1-2 or pN1-2.
* Biopsy-proven involved axillary node(s) (either at baseline and/or at time of surgery).
* Undergone either partial mastectomy (with negative final histologic margins (defined as no tumor on ink, after initial surgery or re-excision)) or mastectomy (with negative histologic margins defined as tumor (either invasive or in situ disease) \> 2 mm from the final margin).
* Nodal surgery with either sentinel lymph node biopsy or axillary lymph node dissection. Effort to recover the original biopsy-proven node should be performed at time of surgery.
* Systemic therapy (chemotherapy and/or endocrine therapy) should be administered as per standard of care and recommendation of medical oncology. Neoadjuvant and/or adjuvant systemic therapy is allowed. Concurrent endocrine therapy, anti-HER2 therapy, and immunotherapy during RT is allowed.
* All radiation therapy must be planned to be delivered at BJH or a Siteman satellite location.
* Female.
* Age ≥ 18 years at diagnosis.
* ECOG Zubrod performance status 0 or 1.
* English speaker.
* Able to understand and willing to sign IRB-approved written informed consent document.

* Presence of distant metastases.
* Diagnosis of nonepithelial breast malignancies such as sarcoma or lymphoma.
* Diagnosis of bilateral breast cancer.
* AJCC cT4 disease, pT4 disease, or any skin involvement on exam or pathology, including dermal LVSI.
* Presence of palpable or radiographically suspicious supraclavicular, infraclavicular, or internal mammary nodes.
* Prior radiation therapy which would have any overlap with current radiation therapy plan.
* Diagnosis of prior breast cancer or diagnosis of current breast cancer more than one year prior to enrollment.
* Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis.
* Diagnosis of a coexisting medical condition which limits life expectancy to \< 2 years.
* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational treatment. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
* Time between last breast cancer therapy (either surgery or chemotherapy) to RT simulation is greater than 8 weeks.
* Planning to undergo concurrent chemotherapy.
* Pregnancy, which will be excluded prior to simulation.

Contacts and Locations

Study Contact

Maria Thomas, M.D., Ph.D.

CONTACT

314-362-8615

mariathomas@wustl.edu

Principal Investigator

Maria Thomas, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Maria Thomas, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-27

Study Completion Date2034-04-30

Study Record Updates

Study Start Date2024-08-27

Study Completion Date2034-04-30

Terms related to this study

Keywords Provided by Researchers

Breast cancer
Radiation
Hypofractionation
QOL
Cosmesis
Toxicity

Additional Relevant MeSH Terms

Node-positive Breast Cancer