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Trial record 2 of 3 for:    janet horton

Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer

This study is currently recruiting participants.
Verified August 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02482376
First Posted: June 26, 2015
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Gateway for Cancer Research
Information provided by (Responsible Party):
Duke University
  Purpose

This protocol seeks to build on the favorable results of the investigators' phase I trial (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered preoperatively to a larger group of subjects (n100).

The primary objective is to determine physician reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale


Condition Intervention Phase
Breast Cancer Radiation: Stereotactic body radiotherapy ( SBRT) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Preoperative Single-Fraction Partial Breast Radiotherapy in Early Stage Breast Cancer: Analysis of Pathologic Response

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Physician reported rates of good/excellent cosmesis. [ Time Frame: Through study completion estimated to be 3 years ]
    Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points


Secondary Outcome Measures:
  • Ki-67 will be assessed as a measure of tumor response [ Time Frame: Through study completion estimated to be 3 years ]
    Ki-67 will be assessed in the pre and post radiotherapy tissue samples

  • Patient reported rates of good/excellent cosmesis [ Time Frame: Through study completion estimated to be 3 years ]
    Patients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints

  • The impact of radiation on gene expression [ Time Frame: Through study completion estimated to be 3 years ]
    Gene expression will be assessed using the Affymetrix Human Transcriptome Array (HTA) arrays designed for formalin fixed paraffin embedded (FFPE) samples on pre and post radiation therapy tissue samples.

  • Local control in the treated breast relative to historic controls [ Time Frame: Through study completion estimated to be 5-10 years ]
    Annual clinical examination combined with breast imaging

  • Assess the impact of RT on circulating cell free DNA [ Time Frame: Through study completion estimated to be 3 years ]
    Oxidative stress biomarkers will be measured in serum and urine collected at the same timepoints


Estimated Enrollment: 100
Study Start Date: October 2015
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm 21Gy stereotactic radiotherapy
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Radiation: Stereotactic body radiotherapy ( SBRT)
Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
Other Name: SBRT

Detailed Description:

The study team hypothesizes that a single fraction of 21Gy can be delivered preoperatively to the intact breast tumor with acceptable cosmetic outcomes. Furthermore, the investigators anticipate that pre- and post-radiation breast tumor samples will provide an avenue for understanding breast cancer radiation response

Rationale for single-fraction preoperative technique

This trial is proposed to build on the favorable results of the investigators' phase I trial by extending the findings to a larger cohort of subjects. The preoperative approach has several advantages:

  1. a small intact breast tumor results in significantly less uninvolved breast tissue receiving high radiation doses which likely decreases toxicity;
  2. more accurate targeting of the high-risk areas of subclinical disease surrounding the tumor is possible,
  3. smaller treatment volumes are amenable to dose escalation which can further accelerate treatment and improve accessibility for subjects,
  4. this technical approach is widely utilized in other tumor sites and can be delivered at most radiation facilities
  5. the pre-operative approach provides a novel opportunity to study breast cancer radiation response.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast

    a. Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis.

  2. 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)
  3. Clinical T1N0M0 invasive carcinoma or Ductal carcinoma in situ (DCIS) < or equal to 2cm
  4. 60 years of age or older or 50-59 with a low Oncotype score (0-17) Oncotype is not required for women diagnosed with DCIS.
  5. Estrogen receptor positive (ER+), Human epidermal growth factor 2 negative (HER2-) HER-2 status is not required for women diagnosed with DCIS.
  6. Women of child-bearing potential must consent to use adequate contraception during the course of the study. Female subjects must agree to use a medically acceptable contraceptives including: (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.
  7. White blood cells (WBC) > 3000, Hemoglobin ( Hgb) > 9, platelets >100000 within 30 days of consent
  8. Eligible for contrasted magnetic resonance imaging (MRI) on initial evaluation with glomerular filtration rate (GFR) ≥ 60 ml/min. A diagnostic MRI ordered within one month will be considered an acceptable alternative and will not be repeated.
  9. Outside breast imaging will be reviewed at Duke to confirm findings are consistent with trial eligibility.

Exclusion Criteria:

  1. Neoadjuvant chemotherapy
  2. Breast implant in the breast to be treated with SBRT
  3. Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
  4. Subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
  5. HER2 positive
  6. Positive serum pregnancy test
  7. Insufficient breast imaging to judge clinical stage
  8. Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
  9. Subjects in whom treatment planning constraints cannot be met
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482376


Contacts
Contact: Eileen Duffy, BNS OCN 919 6683726
Contact: Joan Cahill, BNS OCN CCRP 919 6683726

Locations
United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Eileen Duffy, BNS OCN    919-668-3726      
Contact: Joan Cahill, BNS OCN CCRP    919 6683726      
Principal Investigator: Janet Horton, MD         
Sponsors and Collaborators
Duke University
Gateway for Cancer Research
Investigators
Principal Investigator: Janet Horton, MD Duke University Health System
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02482376     History of Changes
Other Study ID Numbers: Pro00063848
First Submitted: June 22, 2015
First Posted: June 26, 2015
Last Update Posted: August 10, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases