NCT02482389

Study of Preoperative Boost Radiotherapy

Terminated NA Results posted Last updated 14 April 2022

What this trial tests

NA trial testing Single fraction of 7 Gy in Breast Cancer in 3 participants. Terminated before completion.

Timeline

8 September 2015

Primary endpoint
25 June 2021

25 June 2021

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	8 September 2015
Primary completion	25 June 2021
Estimated completion	25 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Single fraction of 7 Gy

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Duke University

Who can join

Adults 18 to 60, 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.

Change in Cosmesis Evaluations Using the NRG Oncology Cosmesis Scale Primary · baseline to 3 years post radiation therapy

Change from baseline rates of cosmesis at 3 years post-treatment as measured by the NRG Oncology cosmesis scale. The scale is scored from 1 (excellent) to 4 (poor) with a lower number representing better physical appearance.

Group	Value	95% CI
Single Arm 7 Gray (Gy) Fraction of Radiotherapy	0	0 – 0

Quality of Life as Measured by Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire Secondary · 3 years

Patient-reported Quality of Life as measured by the Functional Assessment of Cancer Therapy - Breast (FACT-B) at 3 years post-treatment. The FACT-B includes 35 items scored on a Likert-type scale from 0 (not at all) to 4 (very much) with a total scale range of 0-140 and a lower total score indicating a better outcome. Only the total scale score is reported; subscales scores are not reported.

Group	Value	95% CI
Single Arm 7 Gray (Gy) Fraction of Radiotherapy	11.7	± 7.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Arm 7 Gray (Gy) Fraction of Radiotherapy

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (7 terms — click to expand)

Reaction	System	Single Arm 7 Gray (Gy) Fra…
Breast pain	Reproductive system and breast disorders	—
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	—
Fibrosis deep connective tissue	Musculoskeletal and connective tissue disorders	—
Bruising	Injury, poisoning and procedural complications	—
Seroma	Injury, poisoning and procedural complications	—
Other	Reproductive system and breast disorders	—
Other	Injury, poisoning and procedural complications	—

Data from ClinicalTrials.gov NCT02482389 adverse events section.

Sponsor's own description

This protocol seeks to utilize a novel method of tumor bed boost delivery and to better understand breast cancer radiation response through the analysis of pre-and post-radiation breast tumor samples.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.