Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

PRESERVE 2 : 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)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

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 cancer.
 

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

This is a systemic therapy trial.

You may be able to join this trial if:

  • 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.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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)

Commercial Sponsor

G1 Therapeutics, Inc.

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).

Recruiting Hospitals Read MoreRead more

Cabrini Education and Research Precinct
Malvern
Li Hoon Lai
lihoonlai@cabrini.com.au
(03) 9508 3421

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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