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

This study is not yet open for participant recruitment.
Verified November 2017 by Rachel Beth Jimenez, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03340402
First Posted: November 13, 2017
Last Update Posted: November 13, 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:
Federal Share Core
Information provided by (Responsible Party):
Rachel Beth Jimenez, Massachusetts General Hospital
  Purpose
This research study is studying an intervention as a possible treatment for Triple Negative Breast Cancer.

Condition Intervention
Breast Cancer Radiation: Accelerated Partial Breast Irradiation Device: AlignRT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Preoperative Accelerated Partial Breast Irradiation for Triple Negative Breast Cancer Using Proton Beam Scanning

Resource links provided by NLM:


Further study details as provided by Rachel Beth Jimenez, Massachusetts General Hospital:

Primary Outcome Measures:
  • Cumulative incidence of grade ≥ 3 acute dermatitis [ Time Frame: 4 Months ]
    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:
  • The margins needed around Gross Tumor Volume (GTV) [ Time Frame: 4 Months ]
    Summary of the margins needed around gross tumor volume based on the true tumor location.

  • Summary of treatment related adverse events [ Time Frame: 2 years ]
    Summary of the treatment related adverse events experienced by participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)

  • Pathological response rate [ Time Frame: 2 years ]
    Evaluation of the extent of residual active tumor following radiation as assessed on the surgical pathology specimen

  • Rates of local failure [ Time Frame: 2 years ]
    The number of participants with local recurrence of cancer


Estimated Enrollment: 20
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: November 30, 2023
Estimated Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Accelerated Partial Breast Irradiation

Accelerated 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
Radiation: Accelerated Partial Breast Irradiation
Proton radiation
Device: AlignRT
AlignRTTM uses infrafred imaging to capture the 3D data of the patient's position to ensure accuracy of treatment delivery

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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): NCT03340402


Contacts
Contact: Jill McElroy 617-724-3744 jsmcelroy@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Jill McElroy    617-724-3744    jsmcelroy@mgh.harvard.edu   
Principal Investigator: Rachel, Jimenez, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Federal Share Core
Investigators
Principal Investigator: Rachel Jimenez, MD Massachusetts General Hospital
  More Information

Responsible Party: Rachel Beth Jimenez, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03340402     History of Changes
Other Study ID Numbers: 17-416
208901 ( Other Identifier: Federal Share Core )
First Submitted: November 8, 2017
First Posted: November 13, 2017
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Rachel Beth Jimenez, Massachusetts General Hospital:
Breast Cancer

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