A Phase 2 interventional study of Cyclophosphamide and Laboratory Biomarker Analysis in Bilateral Breast Carcinoma, Breast Inflammatory Carcinoma and Stage IB Breast Cancer AJCC v7, sponsored by Academic and Community Cancer Research United. Active, not recruiting at 12 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Academic and Community Cancer Research United · Phase 2, Interventional, and Treatment
Among 78 studies in Inflammatory Breast Neoplasms with a site in United States — 6 open to participants now, 18 under way, none of them phase 3. Inflammatory Breast Neoplasms · United States.
Among the 78 studies in Inflammatory Breast Neoplasms with a site in United States, this one is the 5th largest by enrollment of the 70 interventional ones that give a count, is one of 5 that started in 2017, is one of 41 in phase 2, reaches primary completion later than 5 of the 17 other live ones, and was the 61st registered.
112 studies on the registry are indexed under Inflammatory Breast Neoplasms; 7 are open to participants now.
Browse Inflammatory Breast Neoplasms studies →6 of the 78 studies in Inflammatory Breast Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Wake Forest University Health Sciences · Sites in United States
M.D. Anderson Cancer Center · Sites in United States
Filipa Lynce, MD · Sites in United States
Dana-Farber Cancer Institute · Sites in United States
M.D. Anderson Cancer Center · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Inflammatory Breast Neoplasms studies recruiting now, 5 (83%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
78 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 49 · Phase 3 4
First in 1994; this study’s year is marked. 5 started in 2017.
This study's enrollment of 280 is above the median of 58 across 96 interventional studies indexed under Inflammatory Breast Neoplasms.
Median enrollment 41 across the 70 interventional studies, 250 across the 6 observational. Of the 51 that completed or were terminated, 27 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 78 have an industry lead sponsor. The 10 most frequent:
Academic and Community Cancer Research United is the lead sponsor of 50 studies on the registry; 4 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 12 (92%) have results posted.
Academic and Community Cancer Research United has 1 study filed under Inflammatory Breast Neoplasms — fewer than ten, so there is no comparison to draw.
5 of the studies in Inflammatory Breast Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05383196Antonio Giordano, MDOnvansertib + Paclitaxel In TNBC | 2026-12-15 |
| NCT03941756M.D. Anderson Cancer CenterLymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma | 2027-01-01 |
| NCT04030507Brigham and Women's HospitalScreening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer | 2027-02 |
| NCT03598257National Cancer Institute (NCI)Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer | 2027-06-01 |
| NCT02876107M.D. Anderson Cancer CenterCarboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer | 2027-10-31 |
Among the 78 studies in Inflammatory Breast Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
PRIMARY OBJECTIVE:
I. 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:
I. To compare the safety and tolerability of metronomic cyclophosphamide followed by FRalpha peptide vaccine with GM-CSF versus GM-CSF alone.
CORRELATIVE RESEARCH OBJECTIVES:
I. 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Resected unilateral or bilateral primary carcinoma of the breast without clinical evidence of disease (after 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 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:
Exclusion Criteria:
Any of the following because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
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
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Cyclophosphamide · Other: Laboratory Biomarker Analysis · Biological: Multi-epitope Folate Receptor Alpha Peptide Vaccine · Biological: Sargramostim
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.
Drug: Cyclophosphamide · Other: Laboratory Biomarker Analysis · Other: Placebo Administration · Biological: Sargramostim
Given PO
Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
Correlative studies
Given ID
Also known as: FR Alpha Peptide Vaccine
Given ID
Given ID
Also known as: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin
Disease-free Survival
Will be estimated using the method of Kaplan-Meier. Will use the stratified log-rank tests.
Time frame: 7 years
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.
Time frame: 5 years
Overall Survival
Will be estimated using the method of Kaplan-Meier. Will use the stratified log-rank tests.
Time frame: 7 years
FRalpha Levels
FRalpha levels at baseline will be examined as a prognostic factor in the vaccine immune response. A multivariable Cox proportional hazard model will be used to assess baseline FRalpha levels as a potential prognostic factor for immune response.
Time frame: Through study completion (average of 5 years)
Vaccine Induced Folate Receptor [FR]Alpha-specific T Cell Responses Defined as the Proportion of Patients With at Least a 2-fold Increase in the Number of Cells/Plasma Concentration
Will be determined along with its corresponding 95% confidence interval.
Time frame: Through study completion (average of 5 years)
| Milestone | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) |
|---|---|---|
| Started | 193 | 87 |
| Received treatment | 187 | 85 |
| Completed | 58 | 30 |
| Not completed | 135 | 57 |
| Withdrew: Disease progression | 23 | 7 |
| Withdrew: Adverse event | 12 | 6 |
| Withdrew: Withdrawal by subject | 18 | 3 |
| Withdrew: Alternative therapy | 1 | 0 |
| Withdrew: Withdrawn due to early closure | 66 | 32 |
| Withdrew: Non-compliance | 4 | 3 |
| Withdrew: Complicating disease | 2 | 1 |
| Withdrew: Insurance issues | 2 | 0 |
| Withdrew: Withdrawn to undergo surgery | 1 | 0 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Dosing error | 0 | 1 |
| Withdrew: Withdrawal prior to receiving treatment | 6 | 2 |
Will be estimated using the method of Kaplan-Meier. Will use the stratified log-rank tests.
| months | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) |
|---|---|---|
| Disease-free Survival | NA (NA to NA) | NA (NA to NA) |
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.
| Participants | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) |
|---|---|---|
| Number of Patients Experiencing Grade 3 or Greater Adverse Events Assessed by Common Terminology Criteria for Adverse Events 4.0 | 41 | 19 |
Will be estimated using the method of Kaplan-Meier. Will use the stratified log-rank tests.
| months | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) |
|---|---|---|
| Overall Survival | NA (NA to NA) | NA (NA to NA) |
FRalpha levels at baseline will be examined as a prognostic factor in the vaccine immune response. A multivariable Cox proportional hazard model will be used to assess baseline FRalpha levels as a potential prognostic factor for immune response.
Results for this outcome have not been posted.
Will be determined along with its corresponding 95% confidence interval.
Results for this outcome have not been posted.
Collected over Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (FRalpha Peptide Vaccine, Sargramostim) | 11/193 (5.7%) | 38/187 (20.3%) | 182/187 (97.3%) |
| Arm II (Placebo, Sargramostim) | 2/87 (2.3%) | 14/85 (16.5%) | 83/85 (97.6%) |
| Event | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) |
|---|---|---|
| FatigueGeneral disorders and administration site conditions | 2/187 | 4/85 |
| Injection site reactionGeneral disorders and administration site conditions | 5/187 | 3/85 |
| Peripheral sensory neuropathyNervous system disorders | 2/187 | 3/85 |
| NauseaGastrointestinal disorders | 0/187 | 2/85 |
| Blood bilirubin increasedInvestigations | 0/187 | 2/85 |
| HeadacheNervous system disorders | 0/187 | 2/85 |
| Lung infectionInfections and infestations | 3/187 | 0/85 |
| Neutrophil count decreasedInvestigations | 3/187 | 0/85 |
| White blood cell decreasedInvestigations | 3/187 | 0/85 |
| Eye disorders - Other, specifyEye disorders | 0/187 | 1/85 |
| Event | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) |
|---|---|---|
| Injection site reactionGeneral disorders and administration site conditions | 169/187 | 65/85 |
| FatigueGeneral disorders and administration site conditions | 111/187 | 50/85 |
| Peripheral sensory neuropathyNervous system disorders | 80/187 | 39/85 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 67/187 | 32/85 |
| White blood cell decreasedInvestigations | 50/187 | 26/85 |
| MyalgiaMusculoskeletal and connective tissue disorders | 53/187 | 26/85 |
| AnemiaBlood and lymphatic system disorders | 49/187 | 18/85 |
| NauseaGastrointestinal disorders | 42/187 | 19/85 |
| Lymphocyte count decreasedInvestigations | 42/187 | 10/85 |
| HeadacheNervous system disorders | 33/187 | 15/85 |
| Age, Continuous(years) | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) | Total |
|---|---|---|---|
| Mean | 52.2 ± 10.43 | 53.4 ± 11.02 | 52.6 ± 10.61 |
| Sex: Female, Male(Participants) | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) | Total |
|---|---|---|---|
| Female | 193 | 87 | 280 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) | Total |
|---|---|---|---|
| Hispanic or Latino | 17 | 9 | 26 |
| Not Hispanic or Latino | 165 | 74 | 239 |
| Unknown or Not Reported | 11 | 4 | 15 |
| Race (NIH/OMB)(Participants) | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 14 | 8 | 22 |
| White | 163 | 68 | 231 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 11 | 7 | 18 |
| Region of Enrollment(participants) | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) | Total |
|---|---|---|---|
| United States | 193 | 87 | 280 |
| Prior treatment(Participants) | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) | Total |
|---|---|---|---|
| Adjuvant | 137 | 61 | 198 |
| Neo-adjuvant chemotherapy | 56 | 26 | 82 |
| Disease stage(Participants) | Arm I (FRalpha Peptide Vaccine, Sargramostim) | Arm II (Placebo, Sargramostim) | Total |
|---|---|---|---|
| I/II | 151 | 68 | 219 |
| III | 42 | 19 | 61 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2017 to primary completion in Feb 2025, 94 months.
Results were first posted in Jun 2026, 1 year 4 months after primary completion.
Of 21 phase 2 interventional studies under Inflammatory Breast Neoplasms, half reached primary completion within 94 months of starting (the median), counting those still running; a quarter within 63 and three quarters within 109. This study's 94 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Inflammatory Breast Neoplasms →
Academic and Community Cancer Research United