Clinical trial NCT03340402: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Federal Share Core
name: National Cancer Institute (NCI)
First posted: 2017-11-13
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cumulative incidence of grade ≥ 3 acute dermatitis
timeFrame: 4 Months
Secondary outcomes:
measure: The margins needed around Gross Tumor Volume (GTV)
timeFrame: 4 Months
measure: Summary of treatment related adverse events
timeFrame: 2 years
measure: Pathological response rate
timeFrame: 2 years
measure: Rates of local failure
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Rachel B Jimenez, MD
role: PRINCIPAL_INVESTIGATOR
References: