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Closed (no longer recruiting)Last updated: 27 September 2023

PRESERVE 2: This phase III study is evaluating how safe and effective a targeted therapy (trilaciclib) compared to a placebo is, when given before chemotherapy (gemcitabine and carboplatin), in people with locally advanced or metastatic triple-negative breast cancerA 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)

Clinical summary

Summary

This study will have two separate cohorts, that will both follow the same general study design with identical treatment arms. Cohort 1 will evaluate participants receiving first-line therapy, regardless of programmed death-ligand 1 (PD-L1) status, who are programmed cell death protein 1 (PD-1)/PD-L1 inhibitor therapy naive. Cohort 2 will evaluate PD-L1 positive participants receiving second-line therapy following prior PD-L1/PD-L1 inhibitor therapy in the locally advanced unresectable/metastatic setting. Within each cohort, participants will be randomly assigned to either the Experimental arm or Placebo Comparator arm. In the Experimental Arm, participants will receive Trilaciclib (240mg/m2 administered intravenously [via IV] over 30 mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle), in combination with gemcitabine (1000mg/m2, administered via IV on Day 1 and Day 8 of each 21-day cycle) and carboplatin (AUC 2, administered via IV on Day 1 and Day 8 of each 21-day cycle). In the Placebo Comparator Arm, participants will receive placebo (administered via IV over 30 mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle), in addition to gemcitabine (administered via IV on Day 1 and Day 8 of each 21-day cycle) and carboplatin (administered via IV on Day 1 and Day 8 of each 21-day cycle).

Conditions

This trial is treating patients with triple-negative breast cancer.

Cancer

Breast Cancers Breast

Age

People18+

Phase

III

Trial Acronym

PRESERVE 2

More information

Trial Identifiers

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Commercial Sponsor

G1 Therapeutics, Inc

Scientific 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)

Eligibility

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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