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

NCT03340402 | Withdrawn DMC FDA Device

• 3 other identifiers: 17-4162089012U19CA021239
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The margins needed around Gross Tumor Volume (GTV)

  4 Months

• Summary of treatment related adverse events

  2 years

• Pathological response rate

  2 years

• Rates of local failure

  2 years

Study Arms (1)

Accelerated Partial Breast Irradiation

EXPERIMENTAL

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; Device: AlignRT

Interventions

Accelerated Partial Breast Irradiation RADIATION

Proton radiation

Accelerated Partial Breast Irradiation

AlignRT DEVICE

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

Accelerated Partial Breast Irradiation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Federal Share Core: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rachel B Jimenez, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: December 7, 2017
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: November 14, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)