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Monoclonal Antibodies
Sacituzumab Govitecan for Triple-Negative Breast Cancer (ASCENT-03 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
Individuals presenting with de novo metastatic TNBC
Individuals with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to approximately 57 months
Awards & highlights
ASCENT-03 Trial Summary
This trial is testing a new drug, sacituzumab govitecan-hziy, against the current best treatment option for people with triple-negative breast cancer. The trial will measure how well the new drug works at delaying cancer progression.
Who is the study for?
This trial is for adults with previously untreated advanced or metastatic triple-negative breast cancer that doesn't show PD-L1, or those who've had anti-PD-(L)1 treatment if their tumors are PD-L1 positive. Participants must have good organ function, not be pregnant, and agree to use contraception. They can't join if they've had recent cancer treatments, active infections requiring antibiotics, another active cancer, or haven’t recovered from past treatment side effects.Check my eligibility
What is being tested?
The study compares Sacituzumab Govitecan-hziy (SG), a new drug for breast cancer, against the physician's choice of standard treatments like Paclitaxel or nab-Paclitaxel combined with Gemcitabine and Carboplatin. The main goal is to see which option keeps the cancer from worsening longer (progression-free survival).See study design
What are the potential side effects?
Sacituzumab Govitecan-hziy may cause nausea, diarrhea, hair loss, fatigue and low blood cell counts leading to increased infection risk. Standard chemotherapy drugs can also cause similar side effects including allergic reactions and potential damage to nerves resulting in numbness.
ASCENT-03 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer was already at an advanced stage when first diagnosed.
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I have triple-negative breast cancer that has not been treated and cannot be removed by surgery.
Select...
My cancer can be measured by scans according to specific criteria.
Select...
My triple-negative breast cancer and PD-L1 status are confirmed.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
ASCENT-03 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization up to approximately 57 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to approximately 57 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Secondary outcome measures
Change from Baseline in the Physical Functioning Domain as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30).
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
+5 moreASCENT-03 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sacituzumab Govitecan-hziy (SG)Experimental Treatment1 Intervention
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Group II: Treatment of Physician's Choice (TPC)Active Control4 Interventions
Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens:
Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle
Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle
Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab govitecan
FDA approved
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
847,722 Total Patients Enrolled
17 Trials studying Breast Cancer
6,454 Patients Enrolled for Breast Cancer
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,153 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:- I have triple-negative breast cancer that has not been treated and cannot be removed by surgery.My breast cancer was already at an advanced stage when first diagnosed.I have triple-negative breast cancer that has not been treated and cannot be removed by surgery.I have triple-negative breast cancer that has spread from the start.I am HIV positive and have had Kaposi sarcoma or Multicentric Castleman Disease.I have another type of cancer that is currently active.I have been treated with drugs targeting DNA replication before.I agree to use birth control as required by the study.I have HIV, am on ART, and my infection is well-controlled.I have an active hepatitis B or C infection.My organs are functioning well.My cancer can be measured by scans according to specific criteria.I am still experiencing side effects from a previous treatment.My tumor is PD-L1 negative, or I can't take certain cancer drugs due to other health issues.My triple-negative breast cancer and PD-L1 status are confirmed.I haven't had cancer treatment or radiation in the last 6 months and 2 weeks, respectively.I finished my breast cancer treatment over 6 months ago and it has come back.I am currently taking antibiotics for a serious infection.I am fully active or restricted in physically strenuous activity but can do light work.My tumor is either PD-L1 negative or, if positive, I've had anti-PD-(L)1 treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Sacituzumab Govitecan-hziy (SG)
- Group 2: Treatment of Physician's Choice (TPC)
Awards:
This trial has 4 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Breast Cancer Patient Testimony for trial: Trial Name: NCT05382299 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please share how many locations are conducting this research?
"Currently, this trial is being conducted at 29 different sites. While Santa Barbara, Tucson and Saint Petersburg are some of the locations, there are also other cities included. To limit travel, it is best to enroll at the location closest to you."
Answered by AI
What is the risk profile for Sacituzumab Govitecan-hziy?
"This medication, which is currently in Phase 3 clinical trials, received a safety score of 3. This is based on some data supporting efficacy as well as multiple rounds of data supporting safety."
Answered by AI
Are there any available openings for willing participants in this trial?
"Yes, this clinical trial is still recruiting patients. The original posting was on July 20th, 2020, with the latest update on September 28th, 2020."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
California
North Carolina
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
What site did they apply to?
University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240
Why did patients apply to this trial?
I would like to help where I can, and I feel that these studies can make a difference.
PatientReceived no prior treatments
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