RTOG 1014: A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBRI) For Local Recurrence of Breast Carcinoma
The trial is designed to properly evaluate the ability to safely deliver PBrI. Skin, breast, and chest wall toxicity endpoints will be evaluated at 1-year, 3-year, and 5-year intervals.
1. Histopathologic confirmation via lumpectomy of local in-breast ipsilateral recurrence and final breast surgery (lumpectomy and/or final re-excision) within 42 days prior to study entry. Patients must have had an initial lumpectomy followed by whole breast radiation >1 year prior to study entry.
2.Histology of the local in-breast recurrence consistent with invasive ductal, medullary, tubular, mucinous, lobular; or ductal carcinoma in situ
3.Ipsilateral breast mammogram and MRI within 120 days prior to study entry. Contralateral
breast mammogram within 12 months of study entry.
4.Recurrent tumor size ≤3 cm in greatest dimension on pathologic specimen
5.Negative histologic margins of resection, no tumor on ink, following breast-preserving surgery of local recurrence (Re-excision is permitted to achieve negative margins)
6.Estrogen/progesterone analysis performed prior to study entry
7.Axilla negative or ≤3 positive lymph nodes without extracapsular extension documented after evaluation – as described in section 8.1.15 of the protocol
8. If invasive in-breast recurrence , whole body PET-CT or all of the following: CT of the chest,
abdomen, pelvis and bone scan within 120 days prior to study entry (metastatic work-up not
necessary for Ductal Carcinoma In-Situ Recurrences).9. For females of childbearing potential, negative serum pregnancy test ≤ 7 days prior to study entry
10. History and physical exam performed within 120 days prior to study entry
11.Zubrod Performance status 0-1
12.Age ≥18 years of age
13.The target lumpectomy cavity must be clearly defined and the target lumpectomy cavity/ whole breast reference volume must be <30% based on a postoperative, pretreatment CT scan
14.Patient must provide study specific informed consent prior to study entry.