OncoMatch/Clinical Trials/NCT05770531
Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy
Is NCT05770531 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sacituzumab Govitecan for metastatic her2-negative breast carcinoma.
Treatment: Sacituzumab Govitecan — This phase II trial tests how well evaluating circulating tumor deoxyribonucleic acid (ctDNA) works to guide therapy-change decisions in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic). This study wants to learn if small pieces of DNA associated with a tumor (called circulating tumor DNA, or ctDNA) can be detected in investigational blood tests during the course of standard chemotherapy treatment for breast cancer, and whether information from such investigational ctDNA blood testing could possibly be used as an early indication of chemotherapy treatment failure. It is hoped that additional information from investigational blood testing for ctDNA could help doctors to switch more quickly from a standard chemotherapy treatment that typically has significant side effects and which may not be working, to a different standard treatment regimen against TNBC, called sacituzumab govitecan. Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a chemotherapy drug, called irinotecan. hRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers irinotecan to kill them. Studying ctDNA may assist doctors to change therapy earlier if needed, and may improve health outcomes in patients with metastatic TNBC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 negative (≤ 10% of cells expressing hormonal receptors via IHC analysis) (≤ 10% of cells)
ER and PR negativity are defined as ≤ 10% of cells expressing hormonal receptors via IHC analysis
Required: PR (PGR) negative (≤ 10% of cells expressing hormonal receptors via IHC analysis) (≤ 10% of cells)
ER and PR negativity are defined as ≤ 10% of cells expressing hormonal receptors via IHC analysis
Required: HER2 (ERBB2) negative (ISH non-amplified [ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell], or IHC 0 or IHC 1+) (ISH ratio < 2.0 or copy number < 4 signals/cell, or IHC 0 or 1+)
HER2 negativity is defined as any of the following by local laboratory assessment: ISH non-amplified (ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell), or Immunohistochemistry (IHC) 0 or IHC 1+
Required: PD-L1 (CD274) negative (CPS < 10) or otherwise not appropriate for checkpoint inhibitors (CPS < 10)
PD-L1 negative (combined positive score [CPS] < 10) or otherwise not appropriate for checkpoint inhibitors
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: no prior chemotherapy regimens for metastatic disease
No prior chemotherapy regimens for metastatic disease
Cannot have received: anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biological therapy) other than the ones specified in the protocol
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biological therapy) other than the ones specified in the protocol
Lab requirements
Blood counts
ANC ≥ 1000/mm^3; platelet count ≥ 100,000/mm^3
Liver function
Bilirubin, SGOT, SGPT, alkaline phosphatase ≤ 4x ULN if no liver metastases; total bilirubin, SGOT, SGPT ≤ 6x ULN if liver metastases; serum total bilirubin must be < 3x ULN for patients with Gilbert disease
Cardiac function
Significant cardiovascular disease, such as NYHA class II or greater, MI within 3 months, unstable arrhythmias or angina, LVEF < 35% excluded
ANC ≥ 1000/mm^3; platelet count ≥ 100,000/mm^3; Bilirubin, SGOT, SGPT, alkaline phosphatase ≤ 4x ULN if no liver metastases present; serum total bilirubin must be < 3x ULN for patients with Gilbert disease; total bilirubin, SGOT, SGPT ≤ 6x ULN if liver metastases present; Significant cardiovascular disease, such as NYHA class II or greater, MI within 3 months, unstable arrhythmias or angina, LVEF < 35% excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Vanderbilt University/Ingram Cancer Center · Nashville, Tennessee
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