Clinical trial · Interventional
Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer
Optimizing Preventative Adjuvant Linac-Based Radiation: The OPAL Trial a Phase II/III Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Why stopped (as posted): PI Requested
Summary
Brief summary (as posted)
This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. 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. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Breast Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Early-Stage Breast Carcinoma | Early Stage Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage 0 Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IA Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Partial Breast Irradiation | Radiation | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (hypofractionated partial breast irradiation)
- description
- Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Radiation: Partial Breast Irradiation
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II (hypofractionated partial breast irradiation)
- description
- Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Radiation: Partial Breast Irradiation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in situ * 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: * Tumor invasion of the skin including dermis, chest wall, or pectoralis musculature * 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
References
Publications (1)
- DERIVEDReddy 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. PMID 36216274