EUCTR2016-001314-25-IT
Active, not recruiting
Phase 1
A phase II study of Pembrolizumab plus Carboplatin in BRCA-related metastatic breast cancer - PEMBRACA
AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA0 sites53 target enrollmentStarted: December 11, 2020Last updated:
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 53
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\. Be willing and able to provide written informed consent/assent for the trial.
- •2\. Be ¿ 18 years of age on day of signing informed consent.
- •3\. Patients must have metastatic confirmed breast cancer
- •4\. Disease progression by radiological techniques within 12 months prior to signing informed consent
- •5\. Documented mutation in BRCA1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious (unknown significance variants)
- •6\. Have measurable disease based on RECIST 1\.1\.
- •7\. Prior chemotherapy with anthracyclines and taxanes has to be administered in neoadjuvant or adjuvant setting.
- •8\. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly\-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1\. Subjects for whom newly\-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen
- •9\. Have a performance status of 0 or 1 on the ECOG Performance Scale.
- •10\. Life expectancy of greater than 3 months
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 benign variant of BRCA1/2 genes
- •3\. 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.
- •4\. Has a known history of active TB (Bacillus Tuberculosis)
- •5\. Hypersensitivity to pembrolizumab or any of its excipients.
- •6\. 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.
- •7\. 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 \= Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- •\- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- •8\. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
Investigators
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