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Antimetabolites

Sacituzumab Govitecan + Pembrolizumab for Triple Negative Breast Cancer (ASCENT-05 Trial)

Phase 3
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 96 months
Awards & highlights

ASCENT-05 Trial Summary

This trial will test if a new combination of drugs is more effective and safer than standard treatments for triple negative breast cancer.

Who is the study for?
This trial is for adults over 18 with triple negative breast cancer that remains after pre-surgery treatment and surgery. They must have completed any needed radiotherapy, be in good physical condition (ECOG 0-1), and have proper organ function. Excluded are those with recurrent or stage IV cancer, prior treatments with certain drugs, known BRCA mutations, recent serious heart issues, severe infections, or previous immunotherapy.Check my eligibility
What is being tested?
The study compares the effectiveness of sacituzumab govitecan-hziy (SG) combined with pembrolizumab to the physician's choice of treatment post-surgery for patients with residual triple negative breast cancer. The physician's choice may include pembrolizumab alone or combined with capecitabine.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, fatigue, nausea and vomiting from chemotherapy agents like capecitabine; SG might cause low blood cell counts increasing infection risk.

ASCENT-05 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am over 18 and have triple negative breast cancer remaining after treatment and surgery.
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I have had surgery to remove all visible cancer in my breast or lymph nodes and have recovered.
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I have provided samples from before and after my cancer treatment.

ASCENT-05 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 96 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive Disease-free Survival (iDFS)
Secondary outcome measures
Distant Disease-free Survival (dDFS)
Overall Survival (OS)
Percentage of Participants Experiencing Laboratory Abnormalities
+3 more

ASCENT-05 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sacituzumab govitecan-hziy (SG) + PembrolizumabExperimental Treatment2 Interventions
Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.
Group II: Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + CapecitabineActive Control2 Interventions
Participants will receive one of the following TPC regimens determined prior to randomization: Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles OR Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles and capecitabine 1000 mg/m^2 orally twice daily on Days 1 through 14 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

NSABP Foundation IncNETWORK
88 Previous Clinical Trials
138,788 Total Patients Enrolled
46 Trials studying Breast Cancer
102,330 Patients Enrolled for Breast Cancer
Alliance Foundation Trials, LLC.OTHER
23 Previous Clinical Trials
23,518 Total Patients Enrolled
2 Trials studying Breast Cancer
5,799 Patients Enrolled for Breast Cancer
Gilead SciencesLead Sponsor
1,085 Previous Clinical Trials
846,878 Total Patients Enrolled
17 Trials studying Breast Cancer
6,454 Patients Enrolled for Breast Cancer

Media Library

Capecitabine (Antimetabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05633654 — Phase 3
Breast Cancer Research Study Groups: Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine, Sacituzumab govitecan-hziy (SG) + Pembrolizumab
Breast Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT05633654 — Phase 3
Capecitabine (Antimetabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633654 — Phase 3
~1000 spots leftby Jun 2027
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