Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment radiosurgery
Phase phase 1
Sponsor Duke University
Start date January 2010
End date May 2013
Trial size 32 participants
Trial identifier NCT00944528, Pro00015617

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
radiosurgery External beam radiation therapy
Single dose or radiation in 15Gy, 18Gy or 21Gy
(Experimental)
A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
radiosurgery External beam radiation therapy
Single dose or radiation in 15Gy, 18Gy or 21Gy
(Experimental)
A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
radiosurgery External beam radiation therapy
Single dose or radiation in 15Gy, 18Gy or 21Gy

Primary Outcomes

Measure
Maximum Tolerated Dose
time frame: 30 days

Secondary Outcomes

Measure
Local control
time frame: 3 yrs
Cosmetic outcome
time frame: 3 yrs
Magnetic Resonance Images(MRI)
time frame: Pre and post SRS radiosurgery
Acquire tissue
time frame: Pre and post SRS radiosurgery

Eligibility Criteria

Female participants from 55 years up to 80 years old.

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

Additional Information

Official title Single Dose Partial Breast Radiotherapy Using Extra-cranial Radiosurgery in Patients With Early Stage Breast Cancer - a Phase I Dose Escalation Study
Principal investigator Janet Horton, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Duke University.