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Study of Preoperative Boost Radiotherapy

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. Read our disclaimer for details. Identifier: NCT02482389
Recruitment Status : Active, not recruiting
First Posted : June 26, 2015
Last Update Posted : August 10, 2020
Gateway for Cancer Research
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Single fraction of 7 Gy Not Applicable

Detailed Description:

The study team proposes in this trial to build on the favorable results of the intraoperative boost trials but using a preoperative delivery approach. The PI has demonstrated the feasibility of the preoperative approach and successfully completed a Phase I dose-finding partial breast trial. The preoperative approach has several advantages: 1) expensive intra-operative equipment is unnecessary, 2) a small intact breast tumor results in significantly less uninvolved breast tissue receiving high radiation doses which likely decreases toxicity; 3) more accurate targeting of the high-risk areas of subclinical disease surrounding the tumor is possible, 4) smaller treatment volumes are amenable to dose escalation which can further accelerate treatment and improve accessibility for subjects, and 5) the pre-operative approach provides a novel opportunity to study breast cancer radiation response.

Radiotherapy to the intact tumor is a relatively rare event in breast cancer irradiation, particularly in the setting of early stage breast cancer. Tumor and normal tissue radiation response remain relatively poorly understood. Markers capable of predicting radiation response are rare indeed. Therefore, paired pre- and post-radiation tissue will be examined for FAS gene expression and compared among the breast cancer subtypes. FAS is the name of a gene ( not an acronym) that is known to play a critical role in the induction of programmed cell death and is an established prognostic marker in breast cancer. Previous study team findings that FAS induction appears to be breast cancer subtype-specific has not been previously observed and provides a possible explanation for the differential rates of tumor response observed clinically in distinct breast tumor subtypes. The study team's preclinical work with FAS suggests a potential role as a radiation response biomarker. The study goal is to validate those findings in this large cohort of diverse breast cancer subjects. However, because preoperative delivery of the boost to the intact tumor is unique, this study will include a secondary cosmetic outcome that includes predefined stopping boundaries for early indications of suboptimal cosmetic outcomes with this novel approach

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Preoperative Boost Radiotherapy in Patients With Breast With Biomarker Analysis
Actual Study Start Date : September 8, 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single arm 7 Gray (Gy) fraction of radiotherapy
All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.
Radiation: Single fraction of 7 Gy
All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.

Primary Outcome Measures :
  1. Cosmesis evaluations [ Time Frame: 3 years post radiation therapy for each patient ]
    Document physician and patient-reported change from baseline rates of good/excellent cosmesis at 1, 2, and 3 years post-treatment as measured by the NRG Oncology cosmesis scale

Secondary Outcome Measures :
  1. Evaluate changes in circulating cell free DNA to identify potential radiation response biomarkers [ Time Frame: 5 years ]
    Blood collected pre and post treatment will be used to explore the biologic response to radiotherapy by comparing changes in circulating cell-free DNA expression pre and post-radiotherapy:

  2. Quality of Life [ Time Frame: 3 years ]
    Document physician and patient-reported Quality of Life (FACT-B) at baseline and 1, 2, and 3 years post-treatment.

  3. Composite review of local control [ Time Frame: 5-10 years ]
    Document local control in the treated breast relative to historical controls with annual clinical exam and imaging studies.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. 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)
  3. cTis-T3 cancer judged to benefit (by treating radiation oncologist) from a tumor bed boost
  4. 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.
  5. White blood cell (WBC) > 3000, Hgb > 10, platelets >100000 within 30 days of consent
  6. 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.
  7. Outside breast imaging will be reviewed at Duke to confirm that findings are consistent with trial eligibility

Exclusion Criteria:

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

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 identifier (NCT number): NCT02482389

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United States, North Carolina
Duke Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Gateway for Cancer Research
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Principal Investigator: Rachel Blitzblau, MD PhD Duke University Health System
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Responsible Party: Duke University Identifier: NCT02482389    
Other Study ID Numbers: Pro00063936
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No