KCT0003274
Not yet recruiting
未知
Phase II trial of pembrolizumab in hormone receptor-positive, hyperMUTATted metastatic breast cancer Identified by whole exOme sequeNcing (‘MUTATION2’)
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Pre or postmenopausal women with stage IV hormone receptor\-positive breast cancer by histological or cytological confirmation
- •2\. Be willing and able to provide written informed consent/assent for the trial
- •3\. Progression after 1 or more lines of any systemic therapy (endocrine, HER2\-targeted or chemotherapy) in the metastatic setting
- •4\. Be 19 years of age on day of signing informed consent
- •5\. 70 or more nonsynonymous mutations per tumor by WES
- •6\. Subject who has biopsy\-accessible tumor for WES. Biopsy on breast tumor or axillary nodes is acceptable if locoregional recurrence after primary surgery occurs or de novo stage IV breast cancer is diagnosed
- •7\. Have measurable disease based on RECIST 1\.1\. Biopsied tumor may be counted a measurable lesion if it is not excised
- •8\. Documented disease progression on the most recent therapy
- •9\. Life expectancy of \> 12 weeks
- •10\. Have a performance status of 0 or 1 on the ECOG Performance Scale.
Exclusion Criteria
- •1\.Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •2\.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •3\.Has a known history of active TB (Bacillus Tuberculosis)
- •4\.Hypersensitivity to pembrolizumab or any of its excipients.
- •5\.Has had a prior anti\-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- •6\.Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from adverse events due to a previously administered agent.
- •\-Note: Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., \= Grade 2 neuropathy; hair loss, et al.)
- •\-Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- •7\.Has a known additional malignancy that is progressing or requires active treatment. However, malignancies that have been curatively treated \>5 years prior to study entry can be included. Exceptionally, cervical cancer in\-situ, basal cell carcinoma or squamous cell carcinoma of the skin, papillary thyroid carcinoma and superficial bladder tumors (T1a and Tis) can be included anytime after potentially curative treatment
- •8\.Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
Outcomes
Primary Outcomes
Not specified
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