Clinical trial NCT00944528: Single Dose Partial Breast Radiotherapy
Official title: Single Dose Partial Breast Radiotherapy Using Extra-cranial Radiosurgery in Patients With Early Stage Breast Cancer - a Phase I Dose Escalation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Cancer of Breast
Cancer of the Breast
Neoplasms, Breast
Single dose radiation
Radiotherapy
Preoperative
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 35
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be performed within 3 weeks (+/- 1 week) of completing radiation.

Detailed description: This study will assess the safety of partial breast radiosurgery as measured by the incidence of acute toxicity and wound healing complications in three dose cohorts.

Patients will be enrolled in cohorts of 8 patients starting at dose level 1 (15 Gy). If 2 or more dose limiting toxicities (DLTs) are observed at dose level 1, the trial will be stopped for evaluation and consideration of revision. If at most one DLT is observed then escalation continues to the next dose level. The cohorts will escalate by 3Gy up to 21 Gy of irradiation.

Eligibility criteria: Inclusion Criteria:

* Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in situ or invasive ductal (or other favorable histology) carcinoma of the breast
* Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
* Clinical T1N0M0
* 55 years of age or older
* Estrogen receptor (ER) positive,
* No evidence of lymphovascular space invasion on initial biopsy
* Not pregnant. If not post-menopausal must adhere to birth control measures
* White blood cell count \> 3000, Hemoglobin \> 9, platelets \>100000
* Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min

Exclusion Criteria:

* Neoadjuvant chemotherapy
* Breast implants
* Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
* Patients unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
* HER-2/neu positive
* Positive serum pregnancy test

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 30 days
Secondary outcomes:
measure: Cosmetic Outcome
timeFrame: 3 years
measure: Local Control
timeFrame: 3 years
Other outcomes:
measure: Acquire Tissue
timeFrame: Pre and post SRS radiosurgery
measure: Magnetic Resonance Images(MRI)
timeFrame: Pre and post SRS radiosurgery
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Medical Center, Dept of Radiation Oncology
name: Rachel Blitzblau, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nattinger AB, Hoffmann RG, Kneusel RT, Schapira MM. Relation between appropriateness of primary therapy for early-stage breast carcinoma and increased use of breast-conserving surgery. Lancet. 2000 Sep 30;356(9236):1148-53. doi: 10.1016/S0140-6736(00)02757-4.
citation: Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.
citation: Luini A, Orecchia R, Gatti G, Intra M, Ciocca M, Galimberti V, Veronesi P, Santos GR, Gilardi D, Veronesi U. The pilot trial on intraoperative radiotherapy with electrons (ELIOT): update on the results. Breast Cancer Res Treat. 2005 Sep;93(1):55-9. doi: 10.1007/s10549-005-3782-1.
citation: Horton JK, Siamakpour-Reihani S, Lee CT, Zhou Y, Chen W, Geradts J, Fels DR, Hoang P, Ashcraft KA, Groth J, Kung HN, Dewhirst MW, Chi JT. FAS Death Receptor: A Breast Cancer Subtype-Specific Radiation Response Biomarker and Potential Therapeutic Target. Radiat Res. 2015 Nov;184(5):456-69. doi: 10.1667/RR14089.1. Epub 2015 Oct 21.