Breast Adenocarcinoma, Breast Cancer
Conditions
Keywords
inoperable breast cancer, radiation therapy, breast radiation, novel treatment, new treatment breast, cyberknife, non-invasive, stereotactic radiation
Brief summary
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
RADIATIONWhole 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
RADIATIONWhole 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
Sponsors
Northwell Health
Alexander Stessin
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Safety | 12 months | Incidence of physician-assessed treatment-related toxicity ≥ Grade 4 events, as defined using CTCAE 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Toxicity | 5 years | Percent of participants with any physician-assessed treatment-related Grade 2-5 events using CTCAE 5.0. |
| Treatment Tolerability by EORTC QLQ-C30 | 2 years | Patient reported quality of life measured using the quality of life questionnaire C30 (QLQ-C30), developed by the European Organisation for Research and Treatment of Cancer. This scale includes 5 functional and 3 symptom scales, each scored as a 0-100 scale, where higher scores indicate a better outcome on functional scales and global health status, and a worse outcome on symptoms. |
| Treatment Tolerability by EORTC QLQ-BR42 | 2 years | Patient reported quality of life measured using the quality of life questionnaire BR42 (QLQ-BR42), developed by the European Organisation for Research and Treatment of Cancer. This scale assesses symptoms, body image and sexual functioning scales, each scored as a 0-100 scale, where higher scores indicate worse outcome on symptoms. |
| Acute Toxicity | 12 months | Percent of participants with any physician-assessed treatment-related Grade 1-5 events using CTCAE 5.0. Grade 1 events are limited to fatigue, skin, breast, ribs, heart and lungs. |
| Progression Free Rate in the Microscopic Disease Volume (26Gy) | 1 year | Measured on follow-up MRI or CT imaging using RECIST criteria |
| Clinical Response in patients with Palpable Disease | 1 year | Caliper measurements (2-dimensional) |
| Tumor Response Rate in the Gross Disease Volume (40Gy) | 1 year | Measured on follow-up MRI or CT imaging using RECIST criteria |
Countries
United States
Contacts
Primary ContactCaterina Stony Brook Cancer Center Clinical Trials
Backup ContactCaterina Vacchi-Suzzi, PhD
Outcome results
None listed