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Monoclonal Antibodies

ctDNA-Guided Chemotherapy for Breast Cancer

Q: Has the FDA sanctioned the use of Arm B (biospecimen evaluation, possible treatment change) for public consumption?

<p>Due to the lack of evidence supporting its efficacy, Arm B (biospecimen evaluation and potential treatment alteration) was rated a 2 in terms of safety by our Power team. Phase 2 trials have provided some data that back up this drug's security profile.</p>

Q: Are there positions still available for participants in this experiment?

<p>A review of the clinicaltrials.gov platform reveals that enrollment for this study has been closed since March 3rd, 2023. Although no longer recruiting patients, there are still 4597 other trials seeking candidates at present.</p>

Phase 2

Waitlist Available

Led By Vandana Abramson, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

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 of =< 2

PD-L1 negative (combined positive score [CPS] < 10) or otherwise not appropriate for checkpoint inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial tests if ctDNA from blood tests can help doctors switch more quickly to better treatment for breast cancer.

Who is the study for?

This trial is for adults with metastatic triple-negative breast cancer (TNBC) who haven't had chemotherapy for their advanced disease. They should have normal liver function or slightly elevated levels if liver metastases are present, an ECOG performance status of 0-2, and be PD-L1 negative or unsuitable for checkpoint inhibitors. Participants must not be pregnant, breastfeeding, have other cancers within the last 5 years (except low-risk types), uncontrolled diseases/pain/hypercalcemia, significant heart disease, psychiatric issues affecting compliance, or major surgery within 4 weeks before the trial.Check my eligibility

What is being tested?

The study tests whether monitoring circulating tumor DNA (ctDNA) can guide when to switch from standard chemotherapy to sacituzumab govitecan—a targeted therapy combining a monoclonal antibody with a chemo drug—in patients with spreading TNBC. The goal is to see if ctDNA can indicate early on if the current treatment isn't working and help shift patients sooner to potentially more effective treatments.See study design

What are the potential side effects?

Sacituzumab govitecan may cause side effects like nausea and vomiting due to its chemotherapy component; allergic reactions because it's partly a monoclonal antibody; diarrhea; hair loss; fatigue; decreased blood cell counts leading to higher infection risk; and potential liver toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My cancer is PD-L1 negative or not suitable for certain immune therapies.

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My liver function tests are within normal limits.

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My cancer is not HER2 positive according to tests.

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I haven't had chemotherapy for cancer that has spread.

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I am considered postmenopausal according to medical guidelines.

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My breast cancer is stage IV, ER, PR, HER2 negative.

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My cancer is negative for estrogen and progesterone receptors.

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My bilirubin levels are within normal range, even with Gilbert's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years 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)

Secondary outcome measures

Incidence of adverse events

Overall survival (OS)

Progression free survival 2

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (biospecimen evaluation, possible treatment change)Experimental Treatment4 Interventions

Patients receive providers choice of standard of care chemotherapy and undergo blood sample collection for ctDNA evaluation on study. Patients may receive sacituzumab govitecan IV based on ctDNA results on study. Patients undergo CT or MRI during screening and on study.

Group II: Arm A (biospecimen banking)Active Control3 Interventions

Patients receive providers choice of standard of care chemotherapy and undergo blood sample collection for banking on study. Patients undergo CT or MRI during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,926,013 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,813 Total Patients Enrolled

28 Trials studying Breast Cancer

6,594 Patients Enrolled for Breast Cancer

Vandana Abramson, MDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center

4 Previous Clinical Trials

94 Total Patients Enrolled

Media Library

Sacituzumab Govitecan (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05770531 — Phase 2

Breast Cancer Research Study Groups: Arm B (biospecimen evaluation, possible treatment change), Arm A (biospecimen banking)

Breast Cancer Clinical Trial 2023: Sacituzumab Govitecan Highlights & Side Effects. Trial Name: NCT05770531 — Phase 2

Sacituzumab Govitecan (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05770531 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned the use of Arm B (biospecimen evaluation, possible treatment change) for public consumption?

"Due to the lack of evidence supporting its efficacy, Arm B (biospecimen evaluation and potential treatment alteration) was rated a 2 in terms of safety by our Power team. Phase 2 trials have provided some data that back up this drug's security profile."

Answered by AI

Are there positions still available for participants in this experiment?

"A review of the clinicaltrials.gov platform reveals that enrollment for this study has been closed since March 3rd, 2023. Although no longer recruiting patients, there are still 4597 other trials seeking candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy

Vandana Abramson 2023. "Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05770531.