Definitive Radiation Therapy for Inoperable Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAlexander Stessin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor
RadiationRadiation with 26Gy to the whole breast and 40Gy simultaneous integrated boost to gross disease in the breast, in five fractions
Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes
RadiationRadiation 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
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: A: Ipsilateral axillary node-negative breast cancerExperimental treatment 1 intervention
Group B: B: Ipsilateral axillary node-positive breast cancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Safety
Incidence of physician-assessed treatment-related toxicity ≥ Grade 4 events, as defined using CTCAE 5.0
Time frame
12 monthsSecondary outcomes
1
Acute Toxicity
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.
Time frame
12 months2
Late Toxicity
Percent of participants with any physician-assessed treatment-related Grade 2-5 events using CTCAE 5.0.
Time frame
5 years3
Treatment Tolerability by EORTC QLQ-C30
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.
Time frame
2 years4
Treatment Tolerability by EORTC QLQ-BR42
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.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov