Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer
NCT ID: NCT03077841
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
SUSPENDED
PHASE2/PHASE3
928 participants
INTERVENTIONAL
2017-03-06
2027-11-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery
NCT03624478
Trial of Radiation Fractionation Schedules for Once-a-Day Accelerated Partial Breast Irradiation
NCT02637024
Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
NCT01349322
Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Pts w/Low Risk, Hormone Responsive Brst Ca
NCT06008158
Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes
NCT00668616
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. The risk of grade 2 or higher toxicity occurring during radiation and through the 6 month post-radiation follow up visit in patients treated with Optimizing Preventative Adjuvant Linac-based Radiation (OPAL) regimen.
SECONDARY OBJECTIVES:
I. To measure patient-reported cosmetic outcome, functional status, and breast pain with the OPAL regimen at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen.
II. To measure physician-reported and photographically-assessed cosmetic outcome at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen and to compare this to the best performing arm of 2010-0559.
III. To determine the 5-year risk of pathologically-confirmed invasive and/or in situ ipsilateral breast tumor recurrence (IBTR) for patients with ductal breast carcinoma in situ (DCIS) and early invasive breast cancer.
IV. To determine the 5-year risk of any recurrence of breast cancer, disease-free survival, and overall survival.
V. To determine maximal late (within 5 years) toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 scale.
VI. To establish the feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor.
ARM II: Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor.
After completion of study treatment, patients are followed up at 6 months, and at 1.5, 3.5, and 5.5 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I (hypofractionated partial breast irradiation)
Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor.
Laboratory Biomarker Analysis
Correlative studies
Partial Breast Irradiation
Undergo hypofractionated partial breast irradiation
Questionnaire Administration
Ancillary studies
Arm II (hypofractionated partial breast irradiation)
Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor.
Laboratory Biomarker Analysis
Correlative studies
Partial Breast Irradiation
Undergo hypofractionated partial breast irradiation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laboratory Biomarker Analysis
Correlative studies
Partial Breast Irradiation
Undergo hypofractionated partial breast irradiation
Questionnaire Administration
Ancillary studies
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pathologic T stage of Tis, T1, or T2 with total size of tumor =\< 3 cm (this size criteria applies to both pure DCIS and invasive tumors)
* For patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCIS
* Treatment with breast conserving surgery
* Unifocal primary tumor based on imaging and clinical assessment; microscopic multifocality is allowed
* Final surgical margins negative defined as no tumor on ink; lobular carcinoma in situ involving the final surgical margin will be disregarded
* For invasive cancers, the tumor must be estrogen receptor positive (defined as 10% or greater expression of estrogen receptor)
* If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed at least one month prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer
* Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy
* Final criteria for eligibility established after simulation: The tumor bed can be readily visualized on simulation computed tomography (CT) and is localized to one quadrant or region of the breast that is amenable to partial breast irradiation
Exclusion Criteria
* Any evidence of nodal positivity beyond pathologic stage of pN0(i+)
* Systemic chemotherapy prior to final breast conserving surgery
* Patient is pregnant or nursing
* History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
* History of prior invasive or in situ cancer in either breast
* Current diagnosis of bilateral breast cancer
* History of lupus or scleroderma
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Benjamin D Smith
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Community Cancer Center East
Indianapolis, Indiana, United States
Covenant Medical Center Harrison
Saginaw, Michigan, United States
Summit Medical Group
Berkeley Heights, New Jersey, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, United States
Presbyterian Hospital
Albuquerque, New Mexico, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, United States
MD Anderson in The Woodlands
Conroe, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
MD Anderson West Houston
Houston, Texas, United States
MD Anderson League City
League City, Texas, United States
Saint Luke's Baptist Health System
San Antonio, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Reddy JP, Lei X, Bloom ES, Reed VK, Schlembach PJ, Arzu I, Mayo L, Chun SG, Ahmad NR, Stauder MC, Gopal R, Kaiser K, Fang P, Smith BD; OPAL Trial Investigators. Optimizing Preventive Adjuvant Linac-Based (OPAL) Radiation: A Phase 2 Trial of Daily Partial Breast Irradiation. Int J Radiat Oncol Biol Phys. 2023 Mar 1;115(3):629-644. doi: 10.1016/j.ijrobp.2022.09.083. Epub 2022 Oct 8.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2017-00476
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-1035
Identifier Type: OTHER
Identifier Source: secondary_id
2016-1035
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.