Definitive Radiation Therapy for Inoperable Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor, Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Adenocarcinoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
Overview
The purpose of this study is to find out if adding radiation therapy to routine medications for breast cancer helps in reducing and preventing the cancer from getting worse. Patients with a locally advanced breast cancer who cannot, or do not want to, undergo surgery are eligible to participate. Participation in this study does not prevent you from undergoing surgery in the future.
Detailed description
Patients who cannot undergo surgical resection for either breast cancer or local control of metastatic cancer have limited effective treatment options. Treatments typically employed in the adjuvant setting have been found in the definitive setting to be inferior to surgery followed by adjuvant therapy. This raises the necessity of evaluating the use of ablative doses of radiation to provide durable local control of the tumor in such patients. Indeed, there is growing evidence that RT is effective in the adjuvant setting. This is a study of concurrent ultra-hypofractionated whole breast whole breast radiation delivered via simultaneous integrated boost to the gross tumor for breast cancer patients not undergoing surgery.
Interventions
- Radiation Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor
Radiation with 26Gy to the whole breast and 40Gy simultaneous integrated boost to gross disease in the breast, in five fractions - Radiation Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes
Radiation with 26Gy to the whole breast and regional nodes with a 40Gy simultaneous integrated boost to gross disease in breast and ipsilateral axillary nodal areas, in five fractions
Primary outcome measures
- Treatment Safety [Time frame: 12 months]
Secondary outcome measures (7)
- Acute Toxicity [Time frame: 12 months]
- Late Toxicity [Time frame: 5 years]
- Treatment Tolerability by EORTC QLQ-C30 [Time frame: 2 years]
- Treatment Tolerability by EORTC QLQ-BR42 [Time frame: 2 years]
- Tumor Response Rate in the Gross Disease Volume (40Gy) [Time frame: 1 year]
- Progression Free Rate in the Microscopic Disease Volume (26Gy) [Time frame: 1 year]
- Clinical Response in patients with Palpable Disease [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Biopsy proven invasive carcinoma of the breast, either lobular, ductal and/or no special type
- T1-T4, N0-2, M0-1 invasive breast carcinoma by radiological or clinical criteria
- Cancer is deemed unresectable, or the patient is a poor surgical candidate as determined following evaluation by a surgeon, or patient declines surgery.
- Life expectancy > 6 months
- Negative pregnancy test at the time of start of treatment in any female of reproductive age
Exclusion criteria
- Concurrent systemic therapy (except for endocrine therapy, HER2-targeted therapy, or immunotherapy which are permitted)
- Prior radiation to ipsilateral breast or regional nodes
- Inability to receive study treatment planning and treatment secondary to body habitus
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stony Brook University Cancer Center — Stony Brook
Identifiers
NCT: NCT07122713 · SBU-BREAST-DEFINE · IRB2024-00364