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NEAREST SITE: 273 miles
Sansum Clinic
Santa Barbara,CA

VISITS: Every week (2 weeks on, 1 week off), ongoing

PHASE: III

NCT ID: NCT04799249

Chemotherapy and an Investigational CDK 4/6 Inhibitor for Advanced Triple Negative Breast Cancer

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) Scientific Title

Purpose
To study and compare the safety, side effects, and anti-cancer activity of giving two chemotherapies with the investigational CDK 4/6 inhibitor trilaciclib (Cosela) to chemotherapy alone.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple-negative breast cancer. You must have never received treatment for advanced disease and have never received an anti-PD-L1/PD-1 inhibitor. Or, your cancer must test positive for PD-L1, and your most recently received therapy must have been an anti-PD-L1/PD-1 inhibitor.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Trilaciclib and chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Placebo and chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela) is a type of targeted therapy called a CDK 4/6 inhibitor. Trilaciclib is approved for use in people with other types of cancer, but its use for breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and paraplatin are the chemotherapies used in this trial. They are routinely used to treat advanced and metastatic triple-negative breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04799249' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-treatment-update-2021/' target='_blank'>Metastatic Trial Talk: 2021 Update on Metastatic Triple-Negative Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.g1therapeutics.com/pipeline/trilaciclib/' target='_blank'>G1 Therapeutics Drug Information Page: Trilaciclib</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/gemcitabine.aspx' target='_blank'>Chemocare: Gemcitabine (Gemzar®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/carboplatin' target='_blank'>Cancer Research UK: Carboplatin (Paraplatin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/cdk4-6-inhibitors-make-headway-in-her2-and-triple-negative-breast-cancers' target='_blank'>OncLive: CDK4/6 Inhibitors Make Headway in HER2+ and Triple-Negative Breast Cancers</a> </li></ul>
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