Evaluating ctDNA to Guide Chemotherapy for Metastatic Breast Cancer
This study is for patients with metastatic HER2-negative or triple-negative breast cancer that has spread to other parts of the body. It aims to see if using circulating tumor DNA (ctDNA) – tiny pieces of tumor DNA found in blood – to guide changes in chemotherapy can improve how long patients live without their cancer growing (progression-free survival). You would receive Sacituzumab Govitecan, a chemotherapy drug, given through an IV. Researchers will compare outcomes for patients whose treatment changes are guided by ctDNA results versus those guided by standard imaging like CT scans and MRIs. The study is looking to enroll 160 participants aged 18 or older.
- Study design
- This is an interventional study with a planned enrollment of 160 participants. It aims to compare outcomes between patients whose treatment is guided by ctDNA dynamics and those guided by conventional imaging.
- What's involved
- You would undergo blood sample collection for ctDNA evaluation and banking, as well as CT scans and MRIs. You would also receive Sacituzumab Govitecan by IV.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, progression-free survival, will be measured for up to 3 years.
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NCT05770531
Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy
Recruiting
PHASE2Ages 18+InterventionalTreatmentVanderbilt-Ingram Cancer CenterInvestigator-initiated
~160 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyMagnetic Resonance ImagingSacituzumab Govitecan
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over Up to 3 years
Conditions
Where it's being run
1 sites across 1 statesTennessee1
Study leadership
- Vandana Abramson, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University/Ingram Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Clinical stage IV (metastatic) estrogen receptor (ER), PR, HER2 negative invasive mammary carcinoma, previously documented by histological analysis and that meets the following criteria:
HER2 negativity is defined as any of the following by local laboratory assessment:
In-situ hybridization (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+ (if more than one test result is available and not all results meet the inclusion criterion definition, all results should be discussed with the sponsor-investigator to establish eligibility of the patient)
ER and PR negativity are defined as =\< 10% of cells expressing hormonal receptors via IHC analysis
PD-L1 negative (combined positive score \[CPS\] \< 10) or otherwise not appropriate for checkpoint inhibitors
Patients must have measurable disease according to the standard RECIST version 1.1
Patients must be age \>= 18 years; both male and female are eligible
Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
No prior chemotherapy regimens for metastatic disease
Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained less than 28 days from initiation of study drug)
Platelet count \>= 100,000/mm\^3 (obtained less than 28 days from initiation of study drug)
Bilirubin, serum glutamic oxaloacetic transaminase (SGOT), serum glutatmic pyruvic transaminase (SGPT), alkaline phosphatase =\< 4x upper limits of normal if no liver metastases present
Serum total bilirubin must be \< 3x upper limits of normal for patients with Gilbert disease
Total bilirubin, SGOT, SGPT =\< 6x upper limits of normal if liver metastases present (obtained less than 28 days from initiation of study drug)
For patients who are not postmenopausal (women) or surgically sterile (absence of ovaries and/or uterus or vasectomy), agreement to remain abstinent or to use two adequate methods of contraception (e.g., condoms, diaphragm, vasectomy/vasectomized partner, tubal ligation), during the treatment period and for at least 30 days after the last dose of study treatment. Hormone based oral contraceptives are not allowed on study. Postmenopausal is defined as:
Age \>= 55 years
Age =\< 55 years and amenorrheic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; or follicle stimulating hormone and estradiol in the postmenopausal range
Exclusion
Leptomeningeal disease
Uncontrolled tumor-related pain: patients requiring narcotic pain medication must be on a stable regimen at registration. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization. Patients should be recovered from the effects of radiation. There is no required minimum recovery period. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to randomization
Uncontrolled hypercalcemia (\> 1.5 mmol/L ionized calcium or calcium \> 12 mg/dL or corrected serum calcium \> upper limit of normal \[ULN\]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biological therapy) other than the ones specified in the protocol
Women only: pregnancy or lactation
Evidence of significant uncontrolled concomitant disease that in the opinion of the investigator could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina. Patients with a known left ventricular ejection fraction (LVEF) \< 35% will be excluded. Patients with known coronary artery disease or congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
Major surgical procedure within 4 weeks prior to randomization or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis. Placement of central venous access catheter(s) (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted
Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
What this trial measures
- Progression-free survival (PFS)Up to 3 years
The study survival will be estimated using the Kaplan-Meier method with 95% confidence intervals (CIs). The CI based on the Greenwoods variance will be reported. In addition, the efficacy of the study groups will be compared for PFS with log-rank tests. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age, on the survival data. The adjusted p-values of the hazard ratios and the adjusted 95% confidence intervals will be reported.