A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or second-line treatment for locally advanced unresectable/metastatic TNBC.
• Age \>/= 18 years of age with evaluable locally advanced unresectable or metastatic TNBC.
• Documentation of triple negative breast cancer (estrogen and progesterone receptor \<1% and HER2-negative)
• Prior systemic therapies (Cohort 1 only):
‣ No prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, targeted therapy, immunotherapy, or investigational agents.
⁃ Prior PD-1/PD-L1 inhibitor treatment is not permitted in any setting, including in the neoadjuvant setting.
⁃ Time between completion of last treatment with curative intent and first metastatic recurrence must be ≥ 6 months.
• Prior systemic therapies (Cohort 2 only):
‣ Documentation of PD-L1 positive status
⁃ Treated with a PD-1/PD-L1 inhibitor for a minimum duration of 4 months in the locally advanced unresectable/metastatic setting and as the most recent therapy.
• Radiation therapy for metastatic disease is permitted. There is no required minimum washout period for radiation therapy. Patients should be recovered from the effects of radiation.
• Archival tumor tissue must be available or a fresh biopsy must be obtained, unless approved by the Medical Monitor.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function as demonstrated by normal laboratory values