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.
Primary Objective: To evaluate the effect of trilaciclib on OS compared with placebo
Key Secondary Objective: To assess the effect of trilaciclib on patients quality of life as measured by time to first confirmed deterioration of fatigue compared with placebo
Other Secondary Objectives
To assess the effect of trilaciclib on OS as compared with placebo in the PD-L1-positive subgroup
To assess the effect of trilaciclib on OS as compared with placebo in the PD-L1-negative subgroup
To assess the effect of trilaciclib on PFS as compared with placebo
18 years of age or older with evaluable locally advanced unresectable or metastatic TNBC.
Documentation of triple negative breast cancer (estrogen and progesterone receptor > Prior systemic therapies (Cohort 1 only): (a) No prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, targeted therapy, immunotherapy, or investigational agents. (b) Prior PD-1/PD-L1 inhibitor treatment is not permitted in any setting, including in the neoadjuvant setting. (c) Time between completion of last treatment with curative intent and first metastatic recurrence must be ≥ 6 months.
Prior systemic therapies (Cohort 2 only): (a) Documentation of PD-L1 positive status (b) 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
Prior treatment with carboplatin in the locally advanced unresectable/metastatic setting. Prior carboplatin in the (neo)adjuvant/curative setting is permitted as long as it was completed 6 months or more prior to the first metastatic recurrence.
Presence of central nervous system (CNS) metastases and/or leptomeningeal disease requiring immediate treatment with radiation therapy or steroids.
Receipt of any cytotoxic chemotherapy within 14 days prior to the first dose of study drugs.
QTcF interval >480 msec at Screening (confirmed in triplicate). For patients with ventricular pacemakers, QTcF >500 msec.
Known hypersensitivity to carboplatin or other platinum-containing compounds, or mannitol
Pregnant or lactating women
Prior hematopoietic stem cell or bone marrow transplantation
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