Cryoablation Atezolizumab/Nab-paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer

  • STATUS
    Recruiting
  • participants needed
    5
  • sponsor
    Mayo Clinic
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Updated on 19 February 2024
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cancer
estrogen
breast cancer
atezolizumab
paclitaxel
chemotherapy regimen
monoclonal antibodies
progesterone
monoclonal antibody therapy
estrogen receptor
tumor cells
progesterone receptor
carcinoma
triple negative breast cancer
systemic chemotherapy
cancer chemotherapy
stage iv breast cancer
curative surgery
cryotherapy
pd-l1
breast tumor
metastatic carcinoma
cryosurgery
HER2
stage iiib breast cancer
atezolizumab/nab-paclitaxel
stage iiia breast cancer
prognostic stage iv breast cancer ajcc v8
prognostic stage iiib breast cancer ajcc v8
prognostic stage iii breast cancer ajcc v8
triple negative breast neoplasms
anatomic stage iiib breast cancer ajcc v8
locally advanced breast carcinoma
anatomic stage iiic breast cancer ajcc v8
metastatic triple-negative breast carcinoma

Summary

This early phase I trial studies the side effects and feasibility of cryoablation, atezolizumab, and nab-paclitaxel in treating patients with triple negative breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cryoablation, atezolizumab and nab-paclitaxel may improve response to the disease.

Description

PRIMARY OBJECTIVE:

I. To determine the safety and feasibility of cryoablation of a primary breast tumor followed by PD-L1 blockade in patients with locally advanced or metastatic triple negative breast cancer (TNBC).

SCONDARY OBJECTIVE:

I. To evaluate the systemic immune response to cryoablation of a primary breast tumor and PD-L1 blockade.

OUTLINE

Patients undergo cryoablation of the primary tumor over about 1 hour. After 2-3 weeks, patients receive atezolizumab intravenously (IV) on days 1 and 15 and nab-paclitaxel IV on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2-3 weeks post surgery and then periodically thereafter.

Details
Condition Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
Age 18years - 100years
Treatment Atezolizumab, nab-paclitaxel, Cryosurgery
Clinical Study IdentifierNCT04249167
SponsorMayo Clinic
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Locally advanced or metastatic PD-L1 positive TNBC (TNBC is defined as estrogen receptor [ER] < 10%, progesterone receptor [PR] < 10%, and HER2 non-amplified; and PD-L1 positive is defined as >= 1%.)
Presents with primary breast tumor lesion amenable to cryoablation
Have at least one additional distant lesion feasible for biopsies
Agreeable to start on atezolizumab and nab-paclitaxel as per standard of care
Patients with locally advanced disease must be ineligible for curative surgery for any reason, including but not limited to comorbid status precluding surgery due to safety, unresectability, or patient refusal
Patient may have received prior systemic chemotherapy regimens

Exclusion Criteria

History of autoimmune disease
History of human immunodeficiency virus (HIV)
Previous immune checkpoint targeting therapies
No primary breast lesion amenable for cryoablation due to size (greater than 5 cm) or location (proximity of < 0.5 cm to the skin or nipple-areola complex)
Pregnancy
Clear my responses
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cancer
estrogen
breast cancer
atezolizumab
paclitaxel
chemotherapy regimen
monoclonal antibodies
progesterone
monoclonal antibody therapy
estrogen receptor
tumor cells
progesterone receptor
carcinoma
triple negative breast cancer
systemic chemotherapy
cancer chemotherapy
stage iv breast cancer
curative surgery
cryotherapy
pd-l1
breast tumor
metastatic carcinoma
cryosurgery
HER2
stage iiib breast cancer
atezolizumab/nab-paclitaxel
stage iiia breast cancer
prognostic stage iv breast cancer ajcc v8
prognostic stage iiib breast cancer ajcc v8
prognostic stage iii breast cancer ajcc v8
triple negative breast neoplasms
anatomic stage iiib breast cancer ajcc v8
locally advanced breast carcinoma
anatomic stage iiic breast cancer ajcc v8
metastatic triple-negative breast carcinoma

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