Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19+
SponsorSamsung Medical Center
About this trial
The purpose of this study is to analyze treatment outcomes related to tumor bed boost of postoperative radiation therapy in patient with HER2+ breast cancer who underwent breast conserving surgery.
The main questions it aims to answer are:
* 7-year ipsilateral breast tumor recurrence * 7-year disease-free survival * 7-year locoregional recurrence * 7-year overall survival * Adverse events of radiation therapy
Participants will be assessed by multi-dimensional methods after radiation therapy:
* Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination * Assessment for the adverse events according to CTCAE version 5.0
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients with age minimum 19
Pathological confirmation of HER2+ invasive breast cancer
Eastern Cooperative Oncology Group performance status 0-2
Informed consent of the participant
Disqualifiers
Pathological confirmation of ductal carcinoma in situ of the breast
Previous history of radiation therapy to ipsilateral breast
Trial population
Any HER2+ invasive breast cancer patient with eligible performance except previous history of radiation therapy to ipsilateral breast
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Whole breast irradiation +/- tumor bed boost
RadiationPostoperative whole breast irradiation (3D-conformal radiation therapy or IMRT) with or without tumor bed boost (sequential or simultaneous integrated boost)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Ipsilateral breast tumor recurrence
The event for ipsilateral breast tumor recurrence (IBTR) was defined as any breast tumor recurrence in irradiated breast.
Time frame
7 years from the start of the postoperative radiation therapySecondary outcomes
1
Disease-free survival
The event for disease-free survival (DFS) was defined as any local, regional, or distant recurrence or breast cancer-related death.
Time frame
7 years from the start of the postoperative radiation therapy2
Locoregional recurrence
The event for locoregional recurrence was defined as recurrence in irradiated breast / chest wall or regional lymph node area.
Time frame
7 years from the start of the postoperative radiation therapy3
Overall survival
The event for overall survival (OS) was defined as death of any cause.
Time frame
7 years from the start of the postoperative radiation therapy4
Adverse events
Adverse events were evaluated and graded according to CTCAE version 5.0.
Time frame
7 years from the start of the postoperative radiation therapySponsors and contacts
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Source ClinicalTrials.gov