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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)
Must not have
Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
Active second malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to approximately 57 months
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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My cancer can be measured by scans according to specific criteria.
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My triple-negative breast cancer and PD-L1 status are confirmed.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive and have had Kaposi sarcoma or Multicentric Castleman Disease.
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I have another type of cancer that is currently active.
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I have been treated with drugs targeting DNA replication before.
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I have an active hepatitis B or C infection.
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I am still experiencing side effects from a previous treatment.
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I haven't had cancer treatment or radiation in the last 6 months and 2 weeks, respectively.
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I am currently taking antibiotics for a serious infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to approximately 57 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to approximately 57 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
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 more

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Antibody-drug conjugates (ADCs) like Sacituzumab Govitecan-hziy represent a significant advancement in breast cancer treatment. These therapies combine monoclonal antibodies that specifically target cancer cell markers, such as Trop-2, with potent cytotoxic drugs. By delivering the cytotoxic agent directly to the cancer cells, ADCs minimize damage to healthy tissues, enhancing treatment efficacy and reducing side effects. This targeted approach is particularly important for breast cancer patients, as it offers a more effective and less toxic treatment option, potentially improving survival rates and quality of life.
SABCS 2020: update on triple-negative and metastatic HER2-positive breast cancer.Antibody-drug conjugates as novel anti-cancer chemotherapeutics.Trastuzumab in the Treatment of Breast Cancer.

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,086 Previous Clinical Trials
847,890 Total Patients Enrolled
17 Trials studying Breast Cancer
6,454 Patients Enrolled for Breast Cancer
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,040 Total Patients Enrolled
2 Trials studying Breast Cancer
765 Patients Enrolled for Breast Cancer

Media Library

Sacituzumab Govitecan-hziy (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05382299 — Phase 3
Breast Cancer Research Study Groups: Sacituzumab Govitecan-hziy (SG), Treatment of Physician's Choice (TPC)
Breast Cancer Clinical Trial 2023: Sacituzumab Govitecan-hziy Highlights & Side Effects. Trial Name: NCT05382299 — Phase 3
Sacituzumab Govitecan-hziy (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05382299 — Phase 3
Breast Cancer Patient Testimony for trial: Trial Name: NCT05382299 — Phase 3
~313 spots leftby May 2027