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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Accelerated Partial Breast Irradiation; Device: AlignRT

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 infrared imaging to capture the 3D data of the patient's position to ensure accuracy of treatment delivery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI); Federal Share Core
• Investigators: Principal Investigator: Rachel B Jimenez, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2017
• Primary Completion (ACTUAL): October 23, 2019
• Study Completion (ACTUAL): October 23, 2019

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (ACTUAL): November 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: 17-416; 208901 (OTHER: Federal Share Core); 2U19CA021239 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No