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Monoclonal Antibodies

Sacituzumab Govitecan for Breast Cancer (ASCENT-07 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
Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably from a locally recurrent or metastatic site
Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 60 months
Awards & highlights

ASCENT-07 Trial Summary

This trial will compare a new drug (SG) to current treatments for metastatic breast cancer to see if it can improve life spans. Primary objective is to compare its effect on progression-free survival (PFS).

Who is the study for?
This trial is for adults with HR+/HER2- metastatic breast cancer who've had disease progression despite endocrine therapy. They must have a sample of tumor tissue available, not be candidates for further endocrine treatment, and have adequate organ function. HIV-positive participants need controlled infection on ART. Participants must agree to use contraception and should not be eligible for curative intent therapy or have received certain prior treatments.Check my eligibility
What is being tested?
The study tests if Sacituzumab Govitecan (SG) extends the time without cancer growth in patients with HR+/HER2- metastatic breast cancer compared to standard treatments like Paclitaxel, Nab-paclitaxel, or Capecitabine. It measures how long patients live without their disease getting worse.See study design
What are the potential side effects?
Sacituzumab Govitecan can cause side effects such as nausea, diarrhea, hair loss, fatigue, low blood cell counts leading to increased infection risk or bleeding problems. Standard chemotherapy drugs may also cause similar side effects including allergic reactions.

ASCENT-07 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is hormone receptor positive and has spread, confirmed by a recent biopsy.
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My cancer has grown or spread on my last scan.
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I am about to receive my first chemotherapy for advanced or spread cancer.
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My cancer has worsened despite having at least two different hormone treatments.
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My cancer returned within 24 months while on initial hormone therapy with a CDK 4/6 inhibitor, and I can't have more hormone therapy for advanced cancer.
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I can be treated with capecitabine, nab-paclitaxel, or paclitaxel.
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I am fully active or can carry out light work.
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My cancer is not HER2 positive.

ASCENT-07 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 60 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 Version 1.1 (RECIST v1.1)
Secondary outcome measures
Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16
Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
+6 more

ASCENT-07 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sacituzumab Govitecan-hziy (SG)Experimental Treatment1 Intervention
Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.
Group II: Treatment of Physician's Choice (TPC)Active Control3 Interventions
Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens: paclitaxel 80 mg/m^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. nab-Paclitaxel 100 mg/m^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. capecitabine at 1000-1250 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan-hziy
2019
Completed Phase 3
~550

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,079 Previous Clinical Trials
836,405 Total Patients Enrolled
17 Trials studying Breast Cancer
6,454 Patients Enrolled for Breast Cancer
Gilead Study DirectorStudy DirectorGilead Sciences
342 Previous Clinical Trials
185,668 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: NCT05840211 — 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: NCT05840211 — Phase 3
Sacituzumab Govitecan-hziy (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05840211 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this scientific research presently recruiting participants?

"Clinicaltrials.gov's records display that this study is presently looking for participants. This research was first put up on May 1st of 2023 and has since been tweaked April 21st, 2023."

Answered by AI

What is the total number of participants in this research project?

"Indeed, according to information on clinicaltrials.gov this trial is currently in the recruitment process. The initial posting for this medical study was made on May 1st 2023 and it has been revised as recently as April 21st 2023. 654 participants need to be enrolled from two separate sites."

Answered by AI

Has Sacituzumab Govitecan-hziy (SG) satisfied the requirements for FDA authorization?

"After assessing the available evidence, our team has assigned Sacituzumab Govitecan-hziy (SG) a safety score of 3 as this is an advanced phase trial that provides data supporting both efficacy and security."

Answered by AI
~412 spots leftby Sep 2025