Clinical trial NCT04234386: GammaPod Dose Escalation Radiation for Early Stage Breast Cancer
Official title: GCC 1926- Phase Ib Dose Escalation of Single-Fraction Preoperative Stereotactic Partial-Breast Irradiation for Early-Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The GammaPod machine was made by Xcision Medical Systems and is already FDA cleared to deliver focused radiation within the breast. Unlike current radiation machines, the GammaPod was designed specifically for treating breast cancer. The GammaPod can pinpoint radiation to the tumor bed in the breast which lowers the amount of radiation to nearby tissues. The machine uses a breast cup system to hold the breast in place for the treatment. This breast cup system was tested at MSGCCC (Marlene Stewart Greenebaum Comprehensive Cancer Center). Patients reported this system was more comfortable than an MRI or mammogram. The cup system was able to securely position the breast for treatment in the correct location.

Receiving radiation before surgery is not a new concept in cancer management. Preoperative radiation has proven to result in improved disease free survival in certain types of cancer.

With this study treatment, the participants will receive a dose of breast radiation therapy before the lumpectomy surgery. The lumpectomy surgery is where they remove the participant's tumor.

The purpose of this research study is to determine a safe and effective dose of pre-operative radiation to treat early stage breast cancer. The pre-operative radiation is delivered using the FDA approved, GammaPod machine. The study will also determine the cosmesis of pre-operative radiation at different doses. Cosmesis is another word for looking at skin changes. The research team will use questionnaires for patient and physicians to assess adverse cosmesis changes as accurately as possible. In addition, the investigators are going to assess radiation related changes using photo software analysis tools and patients quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients must sign consent for study participation.
* Patients must be female with a diagnosis of invasive ductal carcinoma. Lobular histologies will not be included, because of difficulty in defining the extent of disease with imaging.
* Patients must be deemed appropriate candidates for breast-conserving therapy (i.e., not pregnant, never had RT to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy).
* Tumor must not involve the overlying skin or underlying chest wall, based on imaging evaluation and/or clinical exam.
* Greatest tumor dimension is \<3 cm based on US. MR imaging measurements can be included only if performed BEFORE the biopsy (postbiopsy measurements can be larger as a result of hematoma formation or increased edema).
* Tumor must be unifocal.
* Patients must be \> 45 years old.
* The tumor must be visible on a CT scan.
* Patients must undergo MR imaging for work-up to aid in tumor delineation and to rule out additional foci of disease. If additional foci of disease are found to be present, then these must be biopsied with negative results to proceed with treatment.
* The tumor must be clinically and radiographically N0 (node negative). If a suspicious node is visualized, it must be biopsied with negative results.
* Patients must be estrogen-receptor positive.
* Patients must be HER2neu negative.
* Patients must weigh \<150 kg (330 lb), which is the limit of the imaging loader.
* Patients must be \<6'6" in height, again because of instrumentation limitations.
* Patients must be able to lie prone for treatment.
* Patients must have no lymphovascular invasion on biopsy.
* Patients may be taking hormonal therapy prior to initiation of treatment. This will be documented.

Exclusion Criteria:

* Multicentric disease.
* Prior RT to the involved breast.
* Inability to fit into the immobilization breast cup because of breast size or other anatomic reasons.
* Inability to obtain an adequate seal when using the immobilization breast cup.
* Male sex.
* Breast implants.
* Patient cannot comfortably lie in the prone position (i.e., physical disability).
* Patients who are planned to be treated surgically with a mastectomy.
* Tumor \<5 mm from the skin surface or chest wall on clinical exam and/or radiographic imaging.
* Tumor size \>3 cm.
* Patients with psychiatric or addictive disorders that would preclude obtaining informed consent or study completion.
* Patients who are pregnant or lactating (because of potential RT exposure to the fetus and unknown effects of RT in lactating women).
* Patient unable to undergo MR imaging (e.g., because of known contrast reaction or concerns about contrast and existing health status).
* Lymphovascular invasion on original biopsy.
* Tumor histologies other than invasive ductal carcinoma (including invasive lobular carcinoma).
* ER-negative tumors.
* HER2neu-positive tumors.
* Pure ductal carcinoma in situ (no invasive component).
* Weight \>330 lb
* Prior ipsilateral breast cancer.
* Diffuse calcifications on mammogram (BIRADS 3, 4, 5).

Primary outcomes:
measure: Establish the single-fraction radiation dose (MTD)
timeFrame: 5 years
measure: Incidence of Dose-Limiting Toxicities (DLTs)
timeFrame: 5 years
Secondary outcomes:
measure: Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
timeFrame: 5 years
measure: Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
timeFrame: 5 years
measure: Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
timeFrame: 5 years
measure: Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
timeFrame: 5 years
measure: Rate of pathologic complete response (pCR)
timeFrame: 5 years
measure: Rate of ipsilateral local tumor recurrence
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: UMMC
state: Maryland
city: Bel Air
country: United States
facility: Upper Chesapeake Health
state: Maryland
city: Columbia
country: United States
facility: Central Maryland Oncology Center
state: Maryland
city: Glen Burnie
country: United States
facility: Baltimore Washington Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Elizabeth Nichols, MD
role: PRINCIPAL_INVESTIGATOR
References: