Clinical Trials /

Preoperative Accelerated Partial Breast Irradiation for Triple Negative Breast Cancer Using Proton Beam Scanning

NCT03340402

Description:

This research study is studying an intervention as a possible treatment for Triple Negative Breast Cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Suspended

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Preoperative Accelerated Partial Breast Irradiation for Triple Negative Breast Cancer Using Proton Beam Scanning
  • Official Title: Pilot Study of Preoperative Accelerated Partial Breast Irradiation for Triple Negative Breast Cancer Using Proton Beam Scanning

Clinical Trial IDs

  • ORG STUDY ID: 17-416
  • SECONDARY ID: 208901
  • NCT ID: NCT03340402

Conditions

  • Breast Cancer

Purpose

This research study is studying an intervention as a possible treatment for Triple Negative Breast Cancer.

Detailed Description

      This research study is a Pilot Study, which means this is the first time investigators are
      examining this study intervention in participants with triple negative breast cancer.

      The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for your
      specific disease but it has been approved for other uses.

      The investigators believe that proton radiation administered in higher doses over a shorter
      time period may help stop cancer from growing while protecting the normal tissue cells.

      In this research study, the investigators are researching how well proton radiation works in
      treating this type of breast cancer. Proton radiation is currently used in other types of
      breast cancer and the investigators believe that the higher doses of proton radiation
      administered over a shorter time period may lead to maximum efficacy in treating this type of
      breast cancer.
    

Trial Arms

NameTypeDescriptionInterventions
Accelerated Partial Breast IrradiationExperimentalAccelerated partial breast irradiation using proton beam scanning will consist of; 5 daily treatments using custom prone patient immobilization, contrast-enhanced CT planning, and daily image guidance Radiation therapy may be delivered with photons if proton treatments cannot be delivered Dose will be prescribed such that the gross tumor (GTV) receives the prescription dose per institutional policy and standard of care Daily target localization will also be confirmed using AlignRTTM

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Age at least 40 years
    
              -  Core biopsy proven estrogen negative (< 1%), progesterone negative (< 1%), and
                 HER2-neu negative (+1 by immunohistochemistry and/or FISH ratio < 2.0) invasive breast
                 cancer
    
              -  Unicentric AJCC 7th edition T1N0M0 tumor measuring no greater than 2.0 cm in longest
                 dimension on initial imaging with either breast MRI and/or mammogram
    
              -  ECOG Performance status < 1
    
              -  No prior treatment for this diagnosis of cancer
    
              -  No prior radiation to the ipsilateral breast, a history of contralateral breast
                 radiation is permitted
    
              -  No clinical or radiographic evidence of malignant regional adenopathy
    
              -  No contraindication to breast conserving surgery, sentinel lymph node biopsy, or
                 radiation therapy
    
              -  Ability to understand and willingness to sign a written informed consent document.
    
              -  Pregnant females are excluded. Female subjects of childbearing potential must indicate
                 to their physician that there is not a possibility of being pregnant at the time of
                 enrollment or have a negative pregnancy test prior to initiation of radiation therapy
    
            Exclusion Criteria:
    
              -  Multicentric breast cancer, defined as discontiguous tumors separated by at least 5 cm
                 of uninvolved tissue or discontiguous tumors that are located within separate breast
                 quadrants either clinical or mammographically.
    
              -  Multifocal breast cancer, defined as discontiguous discrete foci of invasive
                 carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5
                 cm, or within the same breast quadrant.
    
              -  Tumor > 2.0 cm, nodal involvement, or metastatic involvement
    
              -  Patients with either diffuse (>1 quadrant or > 5 cm) suspicious microcalcifications on
                 mammogram or diffuse non-mass-like enhancement on MRI
    
              -  History of ipsilateral cosmetic or reconstructive breast surgery
    
              -  Patients with a pacemaker or defibrillator
    
              -  Any contraindication to MRI including but not limited to the presence of a
                 pacemaker/defibrillator or other implanted ferromagnetic device or an inability to lie
                 prone
    
              -  Pregnant or lactating women
    
              -  Medical condition including but not limited to ongoing or active infection or
                 connective tissue disease (e.g. systemic sclerosis or other collagen vascular
                 diseases) that would, in the opinion of the treating physician, make this protocol
                 unreasonably hazardous to the patient.
    
              -  Psychiatric illness/social situation that would limit ability to provide informed
                 consent
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:40 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Cumulative incidence of grade ≥ 3 acute dermatitis
    Time Frame:4 Months
    Safety Issue:
    Description:The number of participants that experience grade 3 or greater acute dermatitis as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4).

    Secondary Outcome Measures

    Measure:The margins needed around Gross Tumor Volume (GTV)
    Time Frame:4 Months
    Safety Issue:
    Description:Summary of the margins needed around gross tumor volume based on the true tumor location.
    Measure:Summary of treatment related adverse events
    Time Frame:2 years
    Safety Issue:
    Description:Summary of the treatment related adverse events experienced by participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)
    Measure:Pathological response rate
    Time Frame:2 years
    Safety Issue:
    Description:Evaluation of the extent of residual active tumor following radiation as assessed on the surgical pathology specimen
    Measure:Rates of local failure
    Time Frame:2 years
    Safety Issue:
    Description:The number of participants with local recurrence of cancer

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Massachusetts General Hospital

    Trial Keywords

    • Breast Cancer

    Last Updated

    November 9, 2017