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.

ASCENT-04 : A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

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,Treatment | BreastBreast

Trial Overview Read MoreRead more

This phase III study is comparing the effectiveness of a combined treatment of targeted therapy (sacituzumab govitecan-hziy) and immunotherapy (pembrolizumab), with a combined treatment of immunotherapy (pembrolizumab) and the physician's choice of chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin) in people with advanced or metastatic triple negative breast cancer that expresses programmed cell death ligand 1 (PD-L1).
 

This trial is treating patients with triple-negative breast expressing PD-L1.

This is a systemic therapy trial.

You may be able to join this trial if:

  • 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.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • 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.

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 Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

Commercial Sponsor

Gilead Sciences, Inc.

Summary

This trial is for people with locally advanced inoperable or metastatic triple-negative breast cancer expressing PD-L1 who have not received treatment for their advanced disease. People may be eligible if they have received prior treatment for their less advanced cancer. Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive Sacituzumab Govitecan-hziy (SG) + Pembrolizumab. SG will be administered intravenously at a dose of 10mg/kg on Days 1 and 8 of 21-day cycles, and pembrolizumab will be administered intravenously at a dose of 200mg on Day 1 of 21-day cycles. In the Active Comparator Arm, participants will Pembrolizumab + Treatment of Physician's Choice (TPC). Pembrolizumab will be administered intravenously at a dose of 200mg on Day 1 of each 21-day cycle, plus TPC determined prior to randomisation from 1 of the 3 following permitted regiments: paclitaxel (90mg/m^2 on Days 1, 8, and 15 of 29-day cycles); nab-paclitaxel (100mg/m^2 on Days 1, 8 and 15 of 28-day cycles), or gemcitabine (1000mg/m^2) + carboplatin area under the curve 2 (on days 1 and 8 of 21-day cycles).

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Border Medical Oncology
Albury
Ms Kate Oates
koates@bordermedonc.com.au
02 6064 1499

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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