Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Pembrolizumab

Imiquimod

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

* Epicutaneous cryoimmunotherapy treatments (6 total) during weeks 1-15 (every 2 weeks for the first 2 treatments, then every 3 weeks until week 15)
* Topical imiquimod will be applied 5 days per week (5 days on, 2 days off from weeks 1-15)
* Pembrolizumab will be given every 3 weeks for a minimum of 4 cycles starting at Week 3 until disease progression or unacceptable toxicity.
* Intra-lesional GM-CSF 250 mcg every 2 weeks x 2 doses then every 3 weeks for 3 doses

Epicutaneous cryoimmunotherapy (EC) treatment includes liquid nitrogen cryotherapy applied for 10 seconds x 2 freeze-thaw cycles. Four treatment areas will be chosen at each treatment.

Epicutaneous cryoimmunotherapy

Patients will apply the cream directly over the treatment areas and can use up to one packet per day (covers approximately 5 cm x 5 cm).

Topical imiquimod

Pembrolizumab 200 mg will be administered as a 30 minute IV infusion

* 10 questions about how much skin problems has affected the participant's life over the past week
* The scoring of each question is as follows: very much = 3, a lot = 2, a little = 1, not at all = 0, not relevant = 0, and question #7 'prevented work or studying' = 3
* The DLQI is calculated by summing the score of each question resulting in a max of 30 and min of 0. The higher the score, the more quality of life is impaired.

Dermatologic Quality of Life Index

* 5 subscales (physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns)
* Answers ranging from 0=Not at all to 4 = very much
* Each item is rated on a 5-point Likert scale.
* The higher the score on the social/family well-being and functional well-being indicate higher quality of life
* The lower the score on physical well-being, emotional well-being, and additional concerns indicate higher quality of life

Functional Assessment of Cancer Therapy

250 mcg every 2 weeks x 3 doses then every 3 weeks for 3 doses

Intra-lesional GM-CSF

-Device used to give the cryoimmunotherapy

Cry-AC

-Baseline, week 3 (prior to 1st dose of pembrolizumab), week 9, and at week 18. An optional biopsy can be obtained at the time of disease progression.

Cutaneous tumor biopsy

Peripheral blood draw for research

Mateusz Opyrchal, M.D.

The purpose of this research study is to look at the safety and side effects of combining the drug pembrolizumab with imiquimod, GM-CSF, and cryotherapy to treat breast cancer that includes skin lesions.

Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer

Phase IB Pilot Study of Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer

-NCI Common terminology criteria for adverse events (CTCAE v5.0) will be used to grade toxicities

* For patients who present with discrete measurable lesions
* ORR = number of patients who achieve CR or PR divided by the total number response-evaluable patients
* Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
* Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

* Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
* PFS is defined from date on treatment to the earliest date of progression, death, or last follow-up and progression or death are events of interest for PFS.

Spots Global Cancer Trial Database for Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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