Study of Preoperative Boost Radiotherapy

NCT02482389 | Terminated Results

• 1 other identifier: Pro00063936
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Cosmesis Evaluations Using the NRG Oncology Cosmesis Scale

  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.

  baseline to 3 years post radiation therapy

Secondary Outcomes (3)

• Change Circulating Cell Free DNA to Identify Potential Radiation Response Biomarkers

  5 years

• Quality of Life as Measured by Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire

  3 years

• Composite Review of Local Control

  5-10 years

Study Arms (1)

Single arm 7 Gray (Gy) fraction of radiotherapy

EXPERIMENTAL

All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.

Radiation: Single fraction of 7 Gy

Interventions

Single fraction of 7 Gy RADIATION

All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.

Single arm 7 Gray (Gy) fraction of radiotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast. Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis.
• Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric disease preventing resection through a single incision, no pregnant women, and no comorbid conditions precluding surgery)
• cTis-T3 cancer judged to benefit (by treating radiation oncologist) from a tumor bed boost
• Women of child-bearing potential must consent to use adequate contraception during the course of the study: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.
• White blood cell (WBC) \> 3000, Hgb \> 10, platelets \>100000 within 30 days of consent
• Eligible for contrasted magnetic resonance imaging( MRI) on initial evaluation with glomerular filtration rate (GFR) ≥ 60 ml/min. A diagnostic MRI ordered within 60 days of diagnosis will be considered an acceptable alternative and will not be repeated.
• Outside breast imaging will be reviewed at Duke to confirm that findings are consistent with trial eligibility

You may not qualify if:

• Breast implant in the breast to be treated (contralateral breast implant is acceptable)
• Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
• Subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach for at least 1 hour
• Positive serum pregnancy test
• Insufficient breast imaging to judge clinical stage
• Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
• Subjects in whom treatment planning constraints cannot be met

Sponsors & Collaborators

• Duke University: lead
• Gateway for Cancer Research: collaborator

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Joan Cahill
• Organization: Duke University Health System

joan.cahill@duke.edu

(919) 668-5211

Study Officials

• Rachel Blitzblau, MD PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 26, 2015
• Study Start: September 8, 2015
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: April 14, 2022
• Results First Posted: March 23, 2022

Record last verified: 2022-03

Locations

US (1)