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Closed (no longer recruiting)Last updated: 19 December 2024

ASCENT-04: This 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)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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People18+

Trial acronym

ASCENT-04

Clinical summary

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).

Conditions

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

Eligibility

Inclusion

  • Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.

    • Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
    • Individuals presenting with de novo metastatic TNBC are eligible for this study.
    • TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
    • Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Demonstrates adequate organ function
  • Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  • Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.

Exclusion

  • Positive serum pregnancy test or women who are lactating.
  • Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor.
  • Individuals may not have received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment.
  • Individuals may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible.
  • Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.
  • Have an active second malignancy.
  • Have active serious infection requiring antibiotics.
  • Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
  • Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).
  • 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.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You are currently being treated on a clinical trial.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Gilead Sciences, Inc.

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

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