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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 96 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 96 months
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 moreASCENT-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?
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
1,084 Previous Clinical Trials
846,748 Total Patients Enrolled
17 Trials studying Breast Cancer
6,454 Patients Enrolled for Breast Cancer
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
185,179 Total Patients Enrolled
2 Trials studying Breast Cancer
765 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I am currently being treated for a serious infection.I have not been treated with specific immune system drugs or HER2-targeted therapies before.I have completed radiotherapy and recovered before starting this study.I am fully active or can carry out light work.I haven't had a heart attack or severe heart issues in the last 6 months and my heart pumps well.I am over 18 and have triple negative breast cancer remaining after treatment and surgery.I have had surgery to remove all visible cancer in my breast or lymph nodes and have recovered.My cancer has come back after initial treatment and surgery.I have stage IV breast cancer and a history of breast cancer on either side.I have been treated with drugs targeting DNA enzymes or ADCs with a DNA enzyme inhibitor.I have a known BRCA gene mutation.I have provided samples from before and after my cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine
- Group 2: Sacituzumab govitecan-hziy (SG) + Pembrolizumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor still open to new participants?
"According to the clinicaltrials.gov records, this medical experiment is still seeking participants; it was originally posted on December 12th 2022 and its most recent update occurred on December 21st of the same year."
Answered by AI
How many participants are currently taking part in this scientific exploration?
"Yes, the source hosted on clinicaltrials.gov confirms that this experiment is actively recruiting - 1514 volunteers in total from one location have been requested by investigators. It was initially posted December 12th 2022 and most recently modified December 21st 2022."
Answered by AI
To what extent does the combination of Sacituzumab govitecan-hziy (SG) and Pembrolizumab pose a hazard to patients?
"Our team at Power has assigned a safety rating of 3 to Sacituzumab govitecan-hziy (SG) + Pembrolizumab. This is due to the availability of evidence affirming its efficacy in phase 3 trials, along with ample clinical data that supports this drug's security profile."
Answered by AI
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