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RecruitingLast updated: 29 August 2023

ASCENT-03: This phase III study is comparing the effectiveness of targeted therapy (sacituzumab govitecan-hziy) with the physician's choice of chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin) in people with advanced or metastatic triple-negative breast cancerA Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

Clinical summary

Summary

This trial is for people with locally advanced, inoperable or metastatic triple-negative breast cancer who have not received pervious treatment for their advanced cancer, and whose cancer does not express programmed cell death ligand 1 (PD-L1), or people previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose cancers do express PD-L1. Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive Sacituzumab Govitecan-hziy (10mg/mg) intravenously on Days 1 and 8 of a 21-day cycle. In the Active Comparator Arm, participants will treatment of the physician's choice which will be determined prior to randomisation from 1 of the 3 following regiments: paclitaxel (90mg/m^2 on Days 1, 8, and 15 of a 28-day cycle), nab-paclitaxel (100mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), or gemcitabine (1000mg/m^2) + carboplatin (area under the curve (AUC) 2) on days 1 and 8 of a 21-day cycle.

Conditions

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

Cancer

Breast Cancers Breast

Age

People18+

Phase

III

Trial Acronym

ASCENT-03

More information

Trial Identifiers

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Commercial Sponsor

Gilead Sciences, Inc.

Scientific Title

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

Eligibility

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • 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 been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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