Bilateral Breast CarcinomaPhase 2NCT03012100
Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer
A Phase 2 study testing Cyclophosphamide, Laboratory Biomarker Analysis and Multi-epitope Folate Receptor Alpha Peptide Vaccine in people with Bilateral Breast Carcinoma and Breast Inflammatory Carcinoma, run by Academic and Community Cancer Research United at 12 sites in United States.
Trial summary
This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide work to prevent the recurrence of stage 1-3 triple negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bilateral Breast Carcinoma, Breast Inflammatory Carcinoma, Stage IB Breast Cancer AJCC v7
- What is being tested?
- Cyclophosphamide, Laboratory Biomarker Analysis and Multi-epitope Folate Receptor Alpha Peptide Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 12 sitesUnited States
- Study dates
- 31 Mar 2017to 31 Jul 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Female
- Resected unilateral or bilateral primary carcinoma of the breast without clinical evidence of metastatic disease (after neoadjuvant chemotherapy and/or adjuvant chemotherapy), negative for estrogen receptor (ER) and progesterone receptor (PR) (cut-off for positivity is > 10% positive tumor cells with nuclear staining), and negative for HER2 as defined by one of the four situations delineated below:
- HER2 immunohistochemistry (IHC) expression of 0 or 1+ and in-situ hybridization non-amplified
- HER2 IHC expression of 0 or 1+ and in-situ hybridization not done
- HER2 IHC expression of 2+ and in-situ hybridization non-amplified
Show all 24Show fewer
- IHC not done and in-situ hybridization non-amplified
- Note: central review is not required
- Note: If biopsy and surgical specimens are discordant from each other with regard to ER, PR, and/or HER2 status, a patient will be allowed to enroll assuming at least one of the specimens meets the above criteria and no endocrine therapy use is planned going forward
- Completed planned breast CANCER surgeries, any radiation therapy, and any chemotherapy, whichever is last, >= 90 days but not >= 546 days prior to randomization
- Note: Reconstructive and prophylactic surgeries are allowed after randomization (during study treatment)
- Patient had at least one of the following:
- Biopsy or surgery-proven regional node involvement by cancer
- T1c, T2, T3, or T4 disease (with inflammatory disease allowed) identified at the time of surgery or clinically identified prior to neoadjuvant chemotherapy
- No complete response to neoadjuvant chemotherapy (those who did achieve complete response are still eligible if a pre-chemotherapy regional nodal biopsy identified cancer or if the pre-chemotherapy tumor measured > 1 cm)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1
- Absolute neutrophil count (ANC) >= 1500/mm^3 obtained =< 14 days prior to randomization
- Platelet count >= 75,000/uL obtained =< 14 days prior to randomization
- Aspartate transaminase (AST) =< 3 x upper limit of normal (ULN) obtained =< 14 days prior to randomization
- Creatinine =< 1.5 x ULN obtained =< 14 days prior to randomization
- Negative serum pregnancy test done =< 14 days prior to randomization, for women of childbearing potential only
- Provide informed written consent
- Willing to return to enrolling institution for follow-up
- Willing to provide tissue and blood samples for correlative research studies
Who cannot join
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception
- Clinical evidence of local recurrence or distant metastases; Note: New primary tumors are allowed, both contralaterally and ipsilaterally, but a prior breast cancer must have been more than 5 years beforehand
- Known hypersensitivity reaction to GM-CSF
Show all 16Show fewer
- Active autoimmune disease that has required systemic treatment =< 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to randomization; Note: replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment; patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded; patients with Celiac disease controlled with diet modification are not excluded
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- NOTE: Localized fungal or viral infections including of the skin, nails, mouth, and genital area are allowed
- History of other cancer < 5 years prior to consent (except non-melanoma skin cancer or carcinoma in situ of the uterine cervix) or current receipt of treatment another cancer (e.g., monoclonal antibody, small molecule pathway inhibitor)
- Treatment with systemic corticosteroid or immune-modulators =< 7 days prior to randomization
- Concurrent treatment with other experimental drugs or any other systemic anticancer therapy (due to unknown drug-vaccine potential interactions). Use of experimental or other targeted therapy > 3 months prior is allowed as long as it is not Her2-directed
- NOTE: Aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), statins, and other medications commonly used to treat nononcologic, non-autoimmune conditions are allowed
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
- Prior or concurrent use of trastuzumab or other Her2-directed therapy
- Prior or concurrent use of a PD-1 or PD-L1 checkpoint inhibitor (including pembrolizumab) unless the use was >= 3 months prior to randomization
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Carle Cancer Center NCI Community Oncology Research Program
Urbana, Illinois, 61801
About this study
Official title: Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer
This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide work to prevent the recurrence of stage 1-3 triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide may work well together to prevent cancer recurrence after surgery and other standard treatments for triple negative breast cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To show that multi-epitope folate receptor alpha peptide vaccine (folate receptor [FR]alpha peptide vaccine) with sargramostim (GM-CSF) adjuvant will prolong the disease-free survival (DFS) compared to GM-CSF adjuvant treatment in patients with triple negative breast cancer.
SECONDARY OBJECTIVE:
- To compare the safety and tolerability of metronomic cyclophosphamide followed by FRalpha peptide vaccine with GM-CSF versus GM-CSF alone.
CORRELATIVE RESEARCH OBJECTIVES:
- To determine whether high level of antibody and cellular immune response toward the FRalpha measured at baseline is a prognostic factor for vaccine immune response and/or cancer relapse.
II. To determine whether the level of tumor expression of FRalpha at baseline is a prognosis factor for vaccine immune response and/or cancer relapse.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cyclophosphamide orally (PO) twice daily (BID) on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim intradermally (ID) on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 3 years.
- Conditions
- Bilateral Breast Carcinoma, Breast Inflammatory Carcinoma, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7
- Being tested
- Cyclophosphamide, Laboratory Biomarker Analysis, Multi-epitope Folate Receptor Alpha Peptide Vaccine, Placebo Administration, Sargramostim
- Medical subject headings
- Inflammatory Breast Neoplasms, Breast Neoplasms, Triple Negative Breast Neoplasms, Unilateral Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Multi-epitope Folate Receptor Alpha Peptide VaccineBiological
Also called FR Alpha Peptide Vaccine
Given ID
Placebo AdministrationOther
Given ID
SargramostimBiological
Also called 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine
Given ID
| Study group | Role | What they receive |
|---|---|---|
| Arm I (FRalpha peptide vaccine, sargramostim) | Experimental | Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cyclophosphamide; Other: Laboratory Biomarker Analysis; Biological: Multi-epitope Folate Receptor Alpha Peptide Vaccine; Biological: Sargramostim |
| Arm II (placebo, sargramostim) | Placebo comparator | Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cyclophosphamide; Other: Laboratory Biomarker Analysis; Other: Placebo Administration; Biological: Sargramostim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival
Will be estimated using the method of Kaplan-Meier. Will use the stratified log-rank tests.
Measured: 7 years
Secondary outcomes (2)
Number of Patients Experiencing Grade 3 or Greater Adverse Events Assessed by Common Terminology Criteria for Adverse Events 4.0
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed by primary disease site to determine toxicity patterns. The number of patients experiencing a grade 3 or greater AE regardless of attribution will be reported.
Measured: 5 years
Overall Survival
Will be estimated using the method of Kaplan-Meier. Will use the stratified log-rank tests.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start31 Mar 2017
- Primary completion28 Feb 2025
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bilateral 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academic and Community Cancer Research United
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn J Ruddy, Principal investigator, Academic and Community Cancer Research United
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012100
- Sponsor's protocol ID
- RU011501I
- Other IDs
- NCI-2016-01878, RU011501I, P30CA015083
- Status last verified
- Apr 2026
- First submitted
- 29 Dec 2016
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03012100
- Acronym / sponsor ID
- RU011501I
- Conditions
- Bilateral Breast Carcinoma, Breast Inflammatory Carcinoma, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Academic and Community Cancer Research UnitedUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide work to prevent the recurrence of stage 1-3 triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide may work well together to prevent cancer recurrence after surgery and other standard treatments for triple negative breast cancer.
Detailed description
PRIMARY OBJECTIVE:
- To show that multi-epitope folate receptor alpha peptide vaccine (folate receptor [FR]alpha peptide vaccine) with sargramostim (GM-CSF) adjuvant will prolong the disease-free survival (DFS) compared to GM-CSF adjuvant treatment in patients with triple negative breast cancer.
SECONDARY OBJECTIVE:
- To compare the safety and tolerability of metronomic cyclophosphamide followed by FRalpha peptide vaccine with GM-CSF versus GM-CSF alone.
CORRELATIVE RESEARCH OBJECTIVES:
- To determine whether high level of antibody and cellular immune response toward the FRalpha measured at baseline is a prognostic factor for vaccine immune response and/or cancer relapse.
II. To determine whether the level of tumor expression of FRalpha at baseline is a prognosis factor for vaccine immune response and/or cancer relapse.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cyclophosphamide orally (PO) twice daily (BID) on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim intradermally (ID) on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (FRalpha peptide vaccine, sargramostim) | Experimental | Drug: Cyclophosphamide, Other: Laboratory Biomarker Analysis, Biological: Multi-epitope Folate Receptor Alpha Peptide Vaccine, Biological: SargramostimPatients receive cyclophosphamide PO BID on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity. |
| Arm II (placebo, sargramostim) | Placebo comparator | Drug: Cyclophosphamide, Other: Laboratory Biomarker Analysis, Other: Placebo Administration, Biological: SargramostimPatients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age >= 18 years
- Female
- Resected unilateral or bilateral primary carcinoma of the breast without clinical evidence of metastatic disease (after neoadjuvant chemotherapy and/or adjuvant chemotherapy), negative for estrogen receptor (ER) and progesterone receptor (PR) (cut-off for positivity is > 10% positive tumor cells with nuclear staining), and negative for HER2 as defined by one of the four situations delineated below:
- Completed planned breast CANCER surgeries, any radiation therapy, and any chemotherapy, whichever is last, >= 90 days but not >= 546 days prior to randomization
- Patient had at least one of the following:
Key exclusion criteria (16 listed)
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Clinical evidence of local recurrence or distant metastases; Note: New primary tumors are allowed, both contralaterally and ipsilaterally, but a prior breast cancer must have been more than 5 years beforehand
- Known hypersensitivity reaction to GM-CSF
- Active autoimmune disease that has required systemic treatment =< 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to randomization; Note: replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment; patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded; patients with Celiac disease controlled with diet modification are not excluded
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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 |
|---|---|---|
| CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, CiclofosfamidaGiven PO | Drug | Arm I (FRalpha peptide vaccine, sargramostim), Arm II (placebo, sargramostim) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (FRalpha peptide vaccine, sargramostim), Arm II (placebo, sargramostim) |
| Multi-epitope Folate Receptor Alpha Peptide VaccineAlso: FR Alpha Peptide VaccineGiven ID | Biological | Arm I (FRalpha peptide vaccine, sargramostim) |
| Placebo AdministrationGiven ID | Other | Arm II (placebo, sargramostim) |
| SargramostimAlso: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, ProkineGiven ID | Biological | Arm I (FRalpha peptide vaccine, sargramostim), Arm II (placebo, sargramostim) |
Primary outcome
Disease-free Survival
Time frame: 7 years
Will be estimated using the method of Kaplan-Meier. Will use the stratified log-rank tests.
2 secondary outcomes
Number of Patients Experiencing Grade 3 or Greater Adverse Events Assessed by Common Terminology Criteria for Adverse Events 4.0
Time frame: 5 years
Overall Survival
Time frame: 7 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Kathryn J Ruddy principal investigator
Academic and Community Cancer Research United
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Laboratory Biomarker Analysis and Multi-epitope Folate Receptor Alpha Peptide Vaccine in people with Bilateral Breast Carcinoma and Breast Inflammatory Carcinoma, run by Academic and Community Cancer Research United at 12 sites 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 24 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 30 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 12 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (time frame: 7 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 30 Jun 2026.