Metastatic HER2-Negative Breast CarcinomaPhase 2NCT05770531
Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging in people with Metastatic HER2-Negative Breast Carcinoma and Metastatic Triple-Negative Breast Carcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic HER2-Negative Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma
- What is being tested?
- Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
- NOTE: CT scans or MRIs used to assess the measurable disease must have been completed with 28 days prior to the study drug initiation
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Vanderbilt-Ingram Service for Timely Access, 800-811-8480, cip@vumc.org
Vandana Abramson, MD
About this study
Official title: A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer
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.
Read the detailed description
Primary Objective:
- To determine whether patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics demonstrate improved progression-free survival (PFS) compared to control patients assessed conventionally with imaging alone.
PRIMARY OBJECTIVE:
- To determine whether patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics demonstrate improved progression-free survival (PFS) compared to control patients assessed conventionally with imaging alone.
SECONDARY OBJECTIVES:
- To evaluate the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics compared to control patients assessed by conventional imaging alone.
- To determine whether patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics demonstrate improved PFS2 compared to control patients assessed with conventional imaging alone.
- To evaluate overall survival (OS) in patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics compared to control patients assessed by conventional imaging alone.
EXPLORATORY OBJECTIVES:
- To evaluate for unique predictive values of ctDNA-defined clones identified through the blood-based analysis.
- To correlate ctDNA changes with standard imaging.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive providers choice of standard of care chemotherapy and undergo blood sample collection for banking on study.
ARM B: Patients receive providers choice of standard of care chemotherapy and undergo blood sample collection for ctDNA evaluation on study. Patients may receive sacituzumab govitecan intravenously (IV) based on ctDNA results on study.
Patients in both arms A and B undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on study.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months and then every 6 months for 3 years.
- Being tested
- Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Sacituzumab Govitecan
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo blood sample collection for banking
Computed TomographyProcedure or surgery
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Undergo MRI
Biospecimen CollectionProcedure or surgery
Undergo blood sample collection for ctDNA evaluation
Sacituzumab GovitecanBiological
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A (biospecimen banking) | Active comparator | 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. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging |
| Arm B (biospecimen evaluation, possible treatment change) | Experimental | 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. Receives: Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Biological: Sacituzumab Govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
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.
Measured: Up to 3 years
Secondary outcomes (4)
Incidence of adverse events
Adverse events will be graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events version 5.0. Adverse medical events will be tabulated. NCI toxicity grade 3 and grade 4 laboratory abnormalities will be listed.
Measured: From initiation of study-indicated treatment until 30 days after final study-indicated treatment or until initiation of another anticancer therapy, whichever occurs first
Progression free survival 2
The study survival will be estimated using the Kaplan-Meier method with 95% CIs. The CI based on the Greenwoods variance will be reported. In addition, the efficacy of the study groups will be compared for PFS2 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.
Measured: Up to 3 years
Overall survival (OS)
The study survival will be estimated using the Kaplan-Meier method with 95% CIs. The CI based on the Greenwoods variance will be reported. In addition, the efficacy of the study groups will be compared for OS 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.
Measured: Up to 3 years
Response rate (RR)
The exact two-sided 95% confidence intervals for the RR will be reported for each arm. The Fisher's exact test will be used to examine the difference of RR between treatment arms.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start3 Oct 2023
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic HER2-Negative Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Vandana Abramson, Vanderbilt-Ingram Cancer Center
- Investigators
- Vandana Abramson, MD, Principal investigator, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770531
- Sponsor's protocol ID
- VICCBRE2257
- Other IDs
- NCI-2023-01721
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05770531
- Acronym / sponsor ID
- VICCBRE2257
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
- To determine whether patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics demonstrate improved progression-free survival (PFS) compared to control patients assessed conventionally with imaging alone.
PRIMARY OBJECTIVE:
- To determine whether patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics demonstrate improved progression-free survival (PFS) compared to control patients assessed conventionally with imaging alone.
SECONDARY OBJECTIVES:
- To evaluate the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics compared to control patients assessed by conventional imaging alone.
- To determine whether patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics demonstrate improved PFS2 compared to control patients assessed with conventional imaging alone.
- To evaluate overall survival (OS) in patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics compared to control patients assessed by conventional imaging alone.
EXPLORATORY OBJECTIVES:
- To evaluate for unique predictive values of ctDNA-defined clones identified through the blood-based analysis.
- To correlate ctDNA changes with standard imaging.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive providers choice of standard of care chemotherapy and undergo blood sample collection for banking on study.
ARM B: Patients receive providers choice of standard of care chemotherapy and undergo blood sample collection for ctDNA evaluation on study. Patients may receive sacituzumab govitecan intravenously (IV) based on ctDNA results on study.
Patients in both arms A and B undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on study.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (biospecimen banking) | Active comparator | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Magnetic Resonance ImagingPatients 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. |
| Arm B (biospecimen evaluation, possible treatment change) | Experimental | Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Biospecimen Collection, Biological: Sacituzumab GovitecanPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Clinical stage IV (metastatic) estrogen receptor (ER), PR, HER2 negative invasive mammary carcinoma, previously documented by histological analysis and that meets the following criteria:
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo blood sample collection for banking | Procedure or surgery | Arm A (biospecimen banking) |
| Computed TomographyUndergo CT | Procedure or surgery | Arm A (biospecimen banking), Arm B (biospecimen evaluation, possible treatment change) |
| Magnetic Resonance ImagingUndergo MRI | Procedure or surgery | Arm A (biospecimen banking), Arm B (biospecimen evaluation, possible treatment change) |
| Biospecimen CollectionUndergo blood sample collection for ctDNA evaluation | Procedure or surgery | Arm B (biospecimen evaluation, possible treatment change) |
| Sacituzumab GovitecanGiven by IV | Biological | Arm B (biospecimen evaluation, possible treatment change) |
Primary outcome
Progression-free survival (PFS)
Time frame: 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.
4 secondary outcomes
Incidence of adverse events
Time frame: From initiation of study-indicated treatment until 30 days after final study-indicated treatment or until initiation of another anticancer therapy, whichever occurs first
Progression free survival 2
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
Response rate (RR)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vandana Abramson, MD principal investigator
Vanderbilt University/Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging in people with Metastatic HER2-Negative Breast Carcinoma and Metastatic Triple-Negative Breast Carcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanderbilt-Ingram Services for Timely Access (800-811-8480, cip@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.