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Clinical Trial 21199

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT04799249

Phase: Phase III
Principal Investigator: Soyano Muller, Aixa

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Study Title

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




G1T28 (Trilaciclib); Gemzar (gemcitabine); Paraplatin (carboplatin); Placebo (); Trilaciclib (); carboplatin (); gemcitabine ()

Inclusion Criteria

Inclusion Criteria:

  • Female or male patients with evaluable locally advanced unresectable or metastatic TNBC
  • Age 18 years or older
  • Documentation of histologically or cytologically confirmed hormone (estrogen and progesterone) receptor negative tumor by immunohistochemistry (IHC) assessment (defined as > Prior systemic therapies: a. No prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, targeted therapy, immunotherapy, or investigational agents. b. Time between completion of last treatment with curative intent and first metastatic recurrence must be ≥ 6 months. Note, prior PD-1/PD-L1 inhibitor in the (neo)adjuvant/ curative setting does not have time/interval restrictions. Washout of at least 14 days from prior PD-1/PDL1 inhibitor to the first dose of study drug is required. c. Only patients for whom treatment with a PD-1/PD-L1 inhibitor is not an option, either based on clinical eligibility or drug availability, will be enrolled
  • Radiation therapy for metastatic disease is permitted. There is no required minimum washout period for these therapies. 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 defined in protocol
  • Resolution of nonhematologic toxicities from prior systemic therapy, radiation therapy, or surgical procedures to ≤Grade 1 (except alopecia)
  • Predicted life expectancy of 3 months or more
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Please see protocol for detailed instructions on methods of contraception requirements
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol

  • Exclusion Criteria

    Exclusion Criteria:

  • Prior treatment with gemcitabine in any setting.
  • 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
  • Other exclusions may apply

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