Ultrahypofractionated Whole Breast Radiation Following Chemotherapy
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60-100
SponsorMetroHealth Medical Center
About this trial
This is a single institution, non-randomized, non-inferiority study comparing prospectively collected data for acute and late effects on the breast associated with ultrahypofractionated whole breast radiation (WBI) following breast conserving surgery (BCS) and chemotherapy to historical controls for breast cancer (BC) patients who receive hypofractionated RT following BCS and chemotherapy.
Eligibility criteria
Qualifiers
Patients aged at least 60 years with invasive BC (T1-3) with clinically or pathologically negative axillary nodes following BCS who have a high-risk Mammaprint or Oncotype testing and receive chemotherapy. (If no axillary surgery planned, patients must have pre-operative negative axillary ultrasound)
Invasive ductal, lobular, medullary, papillary, colloid (mucinous), or tubular histologies are allowed
Any receptor status is allowed (ER/PR/Her2-neu)
Patients with negative resection margins defined as 2 mm from ink, or a negative re-excision
Disqualifiers
Patients with stage IV BC
Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible)
Prior thoracic or breast RT
Brachytherapy or intraoperative RT (IORT)
Trial design
Treatments tested in this trial
- Ultra-hypofractionated radiation
Treatment groups
213 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov