This is an open-label, multicenter, randomized, Phase 2/3 study in patients with locally recurrent or metastatic triple-negative breast cancer (TNBC) with no more than one prior systemic therapy for locally recurrent or metastatic disease.
The study will consist of 2 parts:
Part 1 is the focus of the current protocol, with a primary endpoint of DCR. DCR data as determined by an IRR will determine whether or not proceeding to Part 2 is warranted. If so, Part 2 will be implemented via a major amendment to the protocol. Meanwhile, sites will remain open with the expectation that Part 2 will be activated
After providing informed consent and completing the screening assessments, patients who meet all inclusion and no exclusion criteria will be randomized in a 1:1 ratio to one of the following treatment arms:
Treatment will continue until objective disease progression, unacceptable toxicity, or the patient's withdrawal of consent.
A survival follow-up period will include the collection of survival, progression of disease if applicable, subsequent anti-cancer therapy every 12 weeks ( 1 week)
| Condition | Triple Negative Breast Cancer |
|---|---|
| Treatment | carboplatin, Gemcitabine, eryaspase (L-asparaginase encapsulated in red blood cells) |
| Clinical Study Identifier | NCT03674242 |
| Sponsor | ERYtech Pharma |
| Last Modified on | 2 July 2022 |
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