Definitive Radiation Therapy for Inoperable Breast Cancer

Alexander Stessin30 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Breast Adenocarcinoma

Interventions

Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumorRADIATION

Radiation 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 nodesRADIATION

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stony Brook University Cancer Center

Stony Brook, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Treatment Safety

Incidence of physician-assessed treatment-related toxicity ≥ Grade 4 events, as defined using CTCAE 5.0

Time frame: 12 months

Secondary Outcomes

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 months

Late Toxicity

Percent of participants with any physician-assessed treatment-related Grade 2-5 events using CTCAE 5.0.

Time frame: 5 years

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 years

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 years

Tumor Response Rate in the Gross Disease Volume (40Gy)

Measured on follow-up MRI or CT imaging using RECIST criteria

Time frame: 1 year

Central Contacts

Caterina Stony Brook Cancer Center Clinical Trials

CONTACT

631-728-7425 cancerclinicaltrials@sronybrookmedicine.edu

Caterina Vacchi-Suzzi, PhD

CONTACT

6312162993 caterina.vacchi-suzzi@stonybrookmedicine.edu

Data from ClinicalTrials.gov

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