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

Primary Purpose

Breast Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Accelerated Partial Breast Irradiation

AlignRT

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Accelerated Partial Breast Irradiation

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

The margins needed around Gross Tumor Volume (GTV)

Summary of the margins needed around gross tumor volume based on the true tumor location.

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)

Pathological response rate

Evaluation of the extent of residual active tumor following radiation as assessed on the surgical pathology specimen

Rates of local failure

The number of participants with local recurrence of cancer

Full Information

NCT ID

NCT03340402

First Posted

November 8, 2017

Last Updated

November 12, 2019

Sponsor

Massachusetts General Hospital

Collaborators

Federal Share Core, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03340402

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Slow Accrual

Study Start Date

December 7, 2017 (Actual)

Primary Completion Date

October 23, 2019 (Actual)

Study Completion Date

October 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Federal Share Core, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Accelerated Partial Breast Irradiation

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Accelerated Partial Breast Irradiation

Intervention Description

Proton radiation

Intervention Type

Device

Intervention Name(s)

AlignRT

Intervention Description

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

Primary Outcome Measure Information:

Title

Cumulative incidence of grade ≥ 3 acute dermatitis

Description

The number of participants that experience grade 3 or greater acute dermatitis as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4).

Time Frame

4 Months

Secondary Outcome Measure Information:

Title

The margins needed around Gross Tumor Volume (GTV)

Description

Summary of the margins needed around gross tumor volume based on the true tumor location.

Time Frame

4 Months

Title

Summary of treatment related adverse events

Description

Summary of the treatment related adverse events experienced by participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)

Time Frame

2 years

Title

Pathological response rate

Description

Evaluation of the extent of residual active tumor following radiation as assessed on the surgical pathology specimen

Time Frame

2 years

Title

Rates of local failure

Description

The number of participants with local recurrence of cancer

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rachel B Jimenez, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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