NCT00944528: RSU

Single Dose Partial Breast Radiotherapy

Completed Phase 1 Results posted Last updated 27 October 2023

What this trial tests

Phase 1 trial testing Radiosurgery in Breast Cancer in 35 participants. Completed in 25 March 2023.

Timeline

28 July 2010

Primary endpoint
4 April 2016

25 March 2023

Quick facts

Lead sponsor	Duke University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	28 July 2010
Primary completion	4 April 2016
Estimated completion	25 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Radiosurgery

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Duke University

Who can join

Adults 55 to 80, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Tolerated Dose Primary · 30 days

As measured by the incidence of acute toxicity and wound healing complications

Group	Value	95% CI
Single Dose Radiosurgery: All Dose Levels	21

Cosmetic Outcome Secondary · 3 years

Percent of patients with excellent or good cosmetic outcome at 3 years based on physician's assessment. EXCELLENT is defined as: when compared to the untreated breast or the original appearance of the treated breast, there is minimal or no difference in the size or shape of the treated breast. The way the breast feels (its texture) is the same or slightly different. There may be thickening, scar tissue, or seroma within the breast but not enough to change the appearance. GOOD is defined as: there is mild asymmetry between the breasts, which means that there is some acceptable difference in t

Group	Value	95% CI
Single Dose Radiosurgery: Dose Level 1	71
Single Dose Radiosurgery: Dose Level 2	100
Single Dose Radiosurgery: Dose Level 3	100

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Dose Radiosurgery: Dose Level 1

Serious: 0/8 (0%)

Deaths: 0/8

Single Dose Radiosurgery: Dose Level 2

Serious: 0/8 (0%)

Deaths: 1/8

Single Dose Radiosurgery: Dose Level 3

Serious: 0/16 (0%)

Deaths: 1/16

Other adverse events (25 terms — click to expand)

Reaction	System	Single Dose Radiosurgery: …	Single Dose Radiosurgery: …	Single Dose Radiosurgery: …
Fibrosis deep connective tissue	Musculoskeletal and connective tissue disorders	—	—	—
Dermatitis radiation	Injury, poisoning and procedural complications	—	—	—
Seroma	Injury, poisoning and procedural complications	—	—	—
Breast pain	Reproductive system and breast disorders	—	—	—
Skin induration	Skin and subcutaneous tissue disorders	—	—	—
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	—	—	—
Skin ulceration	Skin and subcutaneous tissue disorders	—	—	—
Breast atrophy	Reproductive system and breast disorders	—	—	—
Fatigue	General disorders	—	—	—
Breast infection	Infections and infestations	—	—	—
Superficial soft tissue fibrosis	Musculoskeletal and connective tissue disorders	—	—	—
Reproductive system and breast disorders-Other	Reproductive system and breast disorders	—	—	—
Skin and subcutaneous tissue disorders - Other	Skin and subcutaneous tissue disorders	—	—	—
Lymphedema	Vascular disorders	—	—	—
Chest pain -cardiac	Cardiac disorders	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—
Infections and infestations-Other	Infections and infestations	—	—	—
Rash pustular	Infections and infestations	—	—	—
Skin infection	Infections and infestations	—	—	—
Headache	Nervous system disorders	—	—	—
Nipple deformity	Reproductive system and breast disorders	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Telangiectasia	Skin and subcutaneous tissue disorders	—	—	—
Hematoma	Vascular disorders	—	—	—

Data from ClinicalTrials.gov NCT00944528 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. FAS Death Receptor: A Breast Cancer Subtype-Specific Radiation Response Biomarker and Potential Therapeutic Target.
   Horton JK, Siamakpour-Reihani S, Lee CT, Zhou Y, et al · · 2015 · cited 24× · PMID 26488758 · DOI 10.1667/rr14089.1
2. Treatment constraints for single dose external beam preoperative partial breast irradiation in early-stage breast cancer.
   Charaghvandi RK, Yoo S, van Asselen B, Rodrigues A, et al · · 2017 · cited 6× · PMID 29594217 · DOI 10.1016/j.ctro.2017.06.003