Single Dose Partial Breast Radiotherapy

NCT00944528 | Completed Phase 1 Results

• 1 other identifier: Pro00015617
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Cancer of Breast; Cancer of the Breast; Neoplasms, Breast; Single dose radiation; Radiotherapy; Preoperative

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

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

  30 days

Secondary Outcomes (2)

• Cosmetic Outcome

  3 years

• Local Control

  3 years

Other Outcomes (2)

• Acquire Tissue

  Pre and post SRS radiosurgery

• Magnetic Resonance Images(MRI)

  Pre and post SRS radiosurgery

Study Arms (3)

Single dose radiosurgery: Dose Level 1

EXPERIMENTAL

A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

Radiation: Radiosurgery

Single dose radiosurgery: Dose Level 2

EXPERIMENTAL

A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

Radiation: Radiosurgery

Single dose radiosurgery: Dose Level 3

EXPERIMENTAL

A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

Radiation: Radiosurgery

Interventions

Radiosurgery RADIATION

Single dose or radiation in 15Gy, 18Gy or 21Gy

Also known as: External beam radiation therapy

Single dose radiosurgery: Dose Level 1; Single dose radiosurgery: Dose Level 2; Single dose radiosurgery: Dose Level 3

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

• 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.

  PMID: 11030294 BACKGROUND

• 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.

  PMID: 19395195 BACKGROUND

• 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.

  PMID: 16184459 BACKGROUND

• 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.

  PMID: 26488758 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Jennifer Mewshaw, MS RN
• Organization: Assistant Research Practice Manager

Jennifer.Mewshaw@duke.edu

(919) 668-5211

Study Officials

• Rachel Blitzblau, MD PhD

  Duke University Medical Center, Dept of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 23, 2009
• Study Start: July 28, 2010
• Primary Completion: April 4, 2016
• Study Completion: March 25, 2023
• Last Updated: October 27, 2023
• Results First Posted: February 12, 2020

Record last verified: 2023-10

Locations

US (1)