A Study of Pre-Operative Treatment With Cryoablation and Immune Therapy in Early Stage Breast Cancer

NCT02833233 | Completed Results

• 1 other identifier: 16-495
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to evaluate the safety of combining two strategies called "cryoablation" and "immune therapy" in women with curable early stage breast cancer.

Conditions

Breast Cancer

Keywords

Early stage; Resectable; Ipilimumab; Nivolumab; Cryoablation; 16-495

Outcome Measures

Primary Outcomes (1)

• Number of Participants Evaluated for Adverse Events

  Safety will be evaluated for all treated subjects using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0 (CTCAE).

  12 weeks after ipilimumab/nivolumab administration.

Study Arms (1)

Cryoablation and Immune Therapy

EXPERIMENTAL

Patients will undergo breast biopsy with cryoablation 7-10 days prior to the planned surgery, and ipilimumab with nivolumab administration 1-5 days before cryoablation. All patients will undergo surgery at the pre-determined day defined at the initial surgical consultation. Women will receive ipilimumab and nivolumab 1-5 days prior to US or MRI-guided core biopsy and cryoablation date. Intravenous ipilimumab will be administered as a single 1 mg/kg dose to be infused intravenously over 90 minutes. Intravenous nivolumab will be administered as a single 3 mg/kg dose to be infused intravenously over 60 minutes.

Procedure: Cryoablation; Drug: Ipilimumab; Drug: Nivolumab

Interventions

Cryoablation PROCEDURE

Cryoablation and Immune Therapy

Ipilimumab DRUG

Cryoablation and Immune Therapy

Nivolumab DRUG

Cryoablation and Immune Therapy

Eligibility Criteria

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

You may qualify if:

• Women age 18 years or older
• Confirmed histologic diagnosis of invasive adenocarcinoma of the breast, including MSKCC pathology confirmation
• ER, PR and HER2 testing in progress (i.e. on outside or MSKCC biopsy report)
• HER2-positive pathology is permitted
• Operable tumor measuring ≥1.5 cm in maximal diameter
• Any nodal status
• Multifocal and multicentric disease is permitted
• Synchronous bilateral invasive breast cancer is permitted
• The tumor should be more than 5 mm from the skin
• No indication of distant metastases
• Breast surgery planned
• Tumor amenable to cryoablation as determined by radiologist
• ECOG performance status score of 0 or 1
• Screening laboratory values must meet the following criteria:
• White blood cells (WBCs) ≥ 2000/μL

You may not qualify if:

• Inflammatory breast cancer
• Medical history and concurrent diseases
• Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
• Prohibited Treatments and/or Therapies
• Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses). However, use of corticosteroids is allowed for the treatment of immune related Adverse Events (irAEs), or adrenal insufficiency.
• Any non-oncology vaccine therapy used for prevention of infectious diseases within 4 weeks prior to first dose of ipilimumab.
• Prior treatment with a CD137 agonist, ipilimumab or other CTLA4 inhibitor;
• Prior investigational agents within 2 weeks prior to first dose of ipilimumab;
• Prior therapy with any anti-cancer agents including chemotherapy, adjuvant chemotherapy, immunosuppressive agents, surgery or radiotherapy within 2 weeks prior to first dose of ipilimumab.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryosurgery; Ipilimumab; Nivolumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Elizabeth Comen
• Organization: Memorial Sloan Kettering Cancer Center

comene@mskcc.org

646-888-4525

Study Officials

• Elizabeth Comen, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: June 1, 2016
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Locations

US (1)