Primary Outcome Measures:
- Determination of Overall survival (OS) [Time Frame: Until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months]
- Determination of the Optimal Biological Dose (OBD) [Time Frame: Up to 15 months]
- Frequency of adverse events (AEs) [Time Frame: Up to 15 months]
- Severity of adverse events (AEs) [Time Frame: Up to 15 months]
- Duration of adverse events (AEs) [Time Frame: Up to 15 months]
- Occurrence of dose-limiting toxicities (DLTs) [Time Frame: Up to 15 months]
- Occurrence of clinically relevant abnormalities in vital signs [Time Frame: Up to 15 months]
- Occurrence of clinically relevant abnormalities in physical examinations [Time Frame: Up to 15 months]
- Occurrence of clinically relevant abnormalities in 12-lead ECGs [Time Frame: Up to 15 months]
- Occurrence of clinically relevant abnormalities in safety laboratory assessments [Time Frame: Up to 15 months]
Inclusion Criteria:
- Metastatic HR+ positive (estrogen receptor positive and/or progesterone receptor positive) or hormone receptor negative (HR˗), and HER2-neg breast adenocarcinoma, histologically proven by biopsy on the last available tumor tissue
- Participants with HR+ metastatic breast cancer (MBC) who progressed on or after ≥1 line of endocrine based therapy and are indicated to receive chemotherapy for metastatic disease
- Participants with HR˗ MBC (i.e. triple-negative breast cancer [TNBC]) who are indicated to receive paclitaxel chemotherapy without PD 1/PD-L1 therapy in the 1st line setting for metastatic disease
- ECOG performance status 0-1
- Expected survival longer than three months
Exclusion Criteria:
- Prior chemotherapy for metastatic breast adenocarcinoma
- Participants with HR+ MBC who have received <1 line of ET based therapy in the metastatic setting
- Participants with HR+ MBC who are not primary or secondary resistant to ET-based therapy and would be candidates to ET based therapy as per applicable treatment guidelines
- TNBC participants who are candidates for PD-1/PD-L1 therapy in combination with chemotherapy
- Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
Sponsor(s)
Immutep S.A.S.
Principal Investigator(s)
Pavani Chalasani, MD
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