Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorCase Comprehensive Cancer Center
About this trial
The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular or mixed histologies. Three years of time must have elapsed since the end of the last course of whole breast irradiation.
Lesion size < 3 cm treated with a partial mastectomy. Participants with invasive cancer and clinically and radiographically negative axillas do not require an axillary lymph node sampling unless they did not have prior axillary lymph node sampling (e.g. previous cancer was DCIS). Participants with DCIS as their recurrence do not require surgical assessment of the axilla. Repeat sentinel lymph node biopsy is permitted.
Negative resection margins with at least no tumor on ink or a negative re-excision.
Participants with invasive recurrence must have a negative re-staging work-up consisting of either a CT chest/abdomen and a bone scan or a PET scan.
Disqualifiers
Participants with nodal or distant metastatic disease < 3 years since prior radiation.
Participants with invasive pure lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or uncontrolled nonepithelial breast malignancies such as lymphoma or sarcoma.
Participants with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.
Participants with Paget's disease of the nipple.
Trial design
Design model
Single group
Treatments tested in this trial
Radiation Therapy
RadiationWeeks 1, 2 and 3 * Weeks 1, 2 and 3 will include 5 days of treatment. * One radiation treatment to breast on each of the 5 days. Each radiation treatment session will last a 30 minutes.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Radiation Therapy(RT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment-related adverse events as graded by CTCAE criteria
Rate of grade 3+ treatment-related skin, fibrosis, and breast pain adverse events occurring within 1 year from the completion of re-irradiation as graded by CTCAE criteria.
Time frame
1 year from the completion of re-irradiationSecondary outcomes
1
In-breast tumor recurrence rate
The overall in-breast tumor recurrence rate will be estimated using the cumulative incidence function.
Time frame
3 years2
In-breast tumor recurrence rate
The overall in-breast tumor recurrence rate is estimated using the cumulative incidence function.
Time frame
5 years3
In-breast tumor recurrence rate
The overall in-breast tumor recurrence rate will be estimated using the cumulative incidence function.
Time frame
10 years4
Rate of freedom from mastectomy
The freedom from mastectomy rate will be estimated using the cumulative incidence function.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov