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

NCT04249167 | Withdrawn Early Phase 1 DMC FDA Drug

• 3 other identifiers: MC2031NCI-2020-0033319-008704
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Breast Carcinoma; Metastatic Triple-Negative Breast Carcinoma; 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; Prognostic Stage IV Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Safety and Feasibility of cryoablation with systemic atezolizumab/nab-paclitaxel

  All adverse events will be reported by grade using frequencies and relative frequencies, and rates will be estimated using a 90% confidence interval obtained using Jeffrey's prior method.

  5 years

Secondary Outcomes (5)

• Abscopal response in the distant non-cryoablated site(s)

  5 years

• Systemic effector cell and cytokine responses

  At baseline, after cryoablation, and after atezolizumab and nab-paclitaxel

• Overall survival

  Assessed up to 5 years

• Disease-specific survival

  Time from cryoablation until death due to breast cancer or last follow-up, assessed up to 5 years

• Progression-free survival

  Time from cryoablation to tumor growth as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, assessed up to 5 years

Study Arms (1)

Treatment (cryoablation, atezolizumab, nab-paclitaxel)

EXPERIMENTAL

Patients undergo cryoablation of the primary tumor over about 1 hour. After 2-3 weeks, patients receive atezolizumab 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.

Drug: Atezolizumab; Procedure: Cryosurgery; Drug: Nab-paclitaxel

Interventions

Atezolizumab DRUG

Given IV

Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, Tecentriq

Treatment (cryoablation, atezolizumab, nab-paclitaxel)

Cryosurgery PROCEDURE

Undergo cryoablation of the primary tumor

Also known as: Ablation, Cryo, Cryoablation, cryosurgical ablation

Treatment (cryoablation, atezolizumab, nab-paclitaxel)

Nab-paclitaxel DRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel

Treatment (cryoablation, atezolizumab, nab-paclitaxel)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

atezolizumab; Cryosurgery; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations

Study Officials

• Emmanuel M Gabriel

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 30, 2020
• Study Start: January 23, 2020
• Primary Completion: November 17, 2021
• Study Completion: November 17, 2021
• Last Updated: January 6, 2023

Record last verified: 2021-12