Focused Ultrasound and Gemcitabine in Breast Cancer (Breast 54)

Patrick Dillon, MD

Status and phase

Enrolling

Phase 1

Conditions

Breast Cancer

Breast Neoplasms

Treatments

Device: Focused Ultrasound

Other: Gemcitabine and Focused Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT04796220

200277

Details and patient eligibility

About

This study will test the use of focused ultrasound ablation, low-dose gemcitabine (a chemotherapy) and the combination of focused ultrasound ablation plus low-dose gemcitabine in patients with early-stage breast cancers. We will be testing the effects of each of these regimens on cells in the immune system. We hypothesize that the combination of focused ultrasound ablation and gemcitabine will decrease myeloid-derived suppressor cells and will increase T cell activity. We also hypothesize that focused ultrasound ablation and low-dose gemcitabine will be safe and will result in non-inferior surgical completion rates and tumor margin assessments.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Disease Status
- Patients must have histologically confirmed, newly diagnosed breast cancer, stage 1-3 disease and be appropriate surgical candidates for complete resection. Recurrent disease patients must have disease localized to the breast, chest wall or axilla and must be surgical candidates for completion resection of recurrent disease.
- If genomic profiling is performed, then the results must indicate that the cancer is high-risk
- Any receptor status may be eligible (estrogen receptor, progesterone receptor, HER2 receptor)
- Patients must have a lesion in the breast/chest wall/axilla that is accessible to focused ultrasound ablation.

Accessible is defined as the following:

A targetable portion of the tumor must be ≥ 5mm from the skin
The rib cage should not be in the prefocal ultrasound path or behind the target area of the lesion (minimum distance from the posterior aspect of the target area to rib cage must be at least 10 mm).

Participants must have at least one high-risk feature of breast cancer (tumor size and nodal status may be measured by mammogram, MRI, US, CT, or calipers):

Triple negative breast cancer with Tumor size ≥10mm
Lymph node involvement by imaging or biopsy (any receptor status, any size)
Tumor size ≥ 20mm (estrogen receptor positive, HER2 negative)
Tumor size ≥ 10mm (HER2 receptor positive, any ER status)
Tumor size ≥ 10mm and Oncotype or Mammaprint high status (estrogen receptor positive, HER2 negative) *If patient has more than one tumor, then the treated tumor must have a high-risk feature (if 2 tumors meet high risk criteria), they may both be treated).
- Willing and able to provide written consent
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, ≥ 18 years
- Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.
- ECOG performance status of 0-2
- Adequate organ function
- Agreement to adhere to lifestyle considerations throughout the study duration

Exclusion criteria

Received other treatment (standard or investigational) for their current breast cancer.
Pregnant or lactating
Diagnosis of immunodeficiency or receiving systemic steroid therapy within 7 days prior to enrollment with the following exceptions:
- In patients with adrenal or pituitary insufficiency replacement steroid doses are allowed; however, daily doses of 10 mg or more of prednisone (or equivalent) per day administered parenterally or orally are not allowed in patients with normal adrenal and pituitary function.
- Inhaled steroids (e.g.: Advair®, Flovent®, Azmacort®) are permitted at low doses (less than 500 mcg fluticasone per day, or equivalent).
- Topical, nasal, and intra-articular corticosteroids are acceptable.
Known allergic reactions to gemcitabine
Breast implant on the side of the body that will receive HIFU application
Known history of HIV (Patients with HIV will be excluded because immunotherapy may impact the T cell profiling as part of the biologic correlates and the natural history of the disease)
Known active Hepatitis B virus or Hepatitis C virus
Other malignancy other than basal cell carcinoma of the skin or squamous cell carcinoma of the skin that is undergoing potentially curative therapy, ductal carcinoma in situ (DCIS), or in situ cervical cancer
Active infection requiring other systemic therapy
Participants in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator.
Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that precludes participation