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

Study ID
STU 022011-129

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System
  • UT Southwestern Ambulatory Services
  • UT Southwestern Moncrieff Cancer Center
  • UT Southwestern University Hospital– Zale Lipshy
  • UT Southwestern University Hospital—St. Paul

Contact
Tejaswi Cirigiri
214-633-1751
tejaswi.cirigiri@utsouthwestern.edu

Principal Investigator
Ann Spangler

Summary

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.

Participant Eligibility

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.