A Phase 1/2 interventional study of HER2 BATs with Pembrolizumab in Metastatic Breast Cancer, sponsored by University of Virginia. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by University of Virginia · Phase 1/2, Interventional, and Treatment
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Among 18 studies in Breast Neoplasms by University of Virginia — 6 open to participants now, 7 under way, 2 of them phase 3. Breast Neoplasms · University of Virginia.
Among the 18 studies in Breast Neoplasms by University of Virginia, this one is the 13th largest by enrollment of the 17 interventional ones that give a count, is the only one that started in 2017, is one of 2 in phase 1/2, and was the 4th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →6 of the 18 studies in Breast Neoplasms by University of Virginia are open now, in 1 country. Recruiting first, the newest first:
University of Virginia · Sites in United States
Ages 18+
University of Virginia · Sites in United States
Ages 65+ · Women only
University of Virginia · Sites in United States
Ages 18+ · Women only
University of Virginia · Sites in United States
Ages 18+
University of Virginia · Sites in United States
Ages 18+ · Women only
By country, each count listing its studies:
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 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.
18 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 5 · Phase 2 5 · Phase 3 2 · Phase 4 1
First in 2004; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22 is below the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 45 across the 17 interventional studies. Of the 8 that completed or were terminated, 3 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Virginia is the lead sponsor of 677 studies on the registry; 139 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 18 studies in Breast Neoplasms by University of Virginia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In the phase II portion, an additional 12 patients will be treated at the selected dose to further evaluate the safety and preliminary efficacy.
Study treatment includes a combination of 8 infusions of BATs using a previously established schedule and one to three infusions of PBZ (200 mg per dose). PBZ will be added to 8 infusions of BATs in 3 schedules: #1) after the 8th BATs infusion; #2) after the 4th and 8th BATs infusions; and then, #3) before the 1st and after the 4th and 8th BATs infusions.
Once subjects are determined eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. Depending on arm/schedule, about 4-5 weeks later, study treatment will begin. For HER2 BATs, the white blood cells, specifically T cells, are then mixed with two proteins - OKT3 and IL-2 -- which activates the cells to multiply. After approximately 14 days in culture, the activated T cells are coated with OKT3 and trastuzumab/Herceptin (HER2Bi), and washed to remove excess Herceptin in order to produce bispecific antibody armed T cells (BATs). Cells are then frozen and stored until scheduled to be infused.
Follow-up appointment schedule will include clinic visits 2 weeks, 1 month, 3 months, and 6 months after the last dose of Pembrolizumab.
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.
confirmed breast cancer (infiltrating ductal or lobular breast carcinoma) with evidence of measurable disease. Metastatic disease must be proven.
a. Since histologic type, lymphatic permeation, blood vessel invasion, and degree of anaplasia may be prognostic variables, appropriate slides of the primary lesion will be requested for future review. , estrogen, and progesterone receptor positivity will be recorded.
. Patients are required to have at least one measurable non-bone lesion ≥10 mm that has not been irradiated.
a. Measurable metastatic disease documented by radiograph, CT scan, PET/CT, MRI, or physical exam is required. Each subject will be required to have at least one measurable lesion that has not been irradiated with a minimum size in at least one diameter of ≥ 10 mm for liver lesions, lung, skin, and ≥ 15 mm lymph node metastases. Biopsy of recurrent site(s) is not required.
Patients must have HER2 status determined by FISH or IHC. HER2 status of positive or negative are both eligible for the study.
In order to be eligible for participation in this trial, the patient must also:
Demonstrate adequate organ function as defined below, all screening labs should be performed within 10 days prior to apheresis.
Absolute lymphocyte count ≥ 500/mm3 (ANC) ≥1,500 /mcL ≥ 100,000 / mcL ≥ 9 g/dL (or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) BUN ≤ 1.5 X (ULN) Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR Measured or calculated ( can also be used in place of creatinine or CrCl) ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN Serum total ≤ 1.5 X ULN OR (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases Albumin >2.5 mg/dL (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy Activated Partial Thromboplastin Time (aPTT) as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Exclusion Criteria:
The patient must be excluded from participating in the trial if the subject:
Has a history of significant cardiac disease, including:
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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 study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
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.
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.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
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.
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.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4.
Drug: HER2 BATs with Pembrolizumab
At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7.
Drug: HER2 BATs with Pembrolizumab
At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7.
Drug: HER2 BATs with Pembrolizumab
8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab
This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.
Dose Limiting Toxicities (Escalation and Expansion Cohorts)
Maximum tolerated dose will be based on number of dose limiting toxicities in each schedule/arm
Time frame: From start of study treatment until 3 weeks after last dose of study treatment, assessed over about 10 weeks.
Dose Limiting Toxicities on the Selected Arm in the Expansion Cohort
Dose Limiting toxicities on the arm selected based on the dose/schedule selection part of the study.
Time frame: From start of study treatment until 3 weeks after last dose of study treatment, assessed over about 10 weeks.
Objective Response Rate
The percentage of subjects with a response of complete response (CR) or partial response (PR) per immune related response criteria (irRC)
Time frame: Imaging will be done prior to study treatment, 1 month, 3 months and 6 months after completion of study treatment (about 8.5 months after starting study treatment). Imaging will then be performed according to standard of care.
Overall Survival
Time from enrollment until death from any cause
Time frame: Every 3 months following last study visit until death
Progression-Free Survival
Time from enrollment to time of first progression after enrollment (days)
Time frame: Checked from enrollment through first progression, about every 3 months, through death or end of study
Immune Response to Treatment in Blood
Sequential monitoring of phenotype, IFN-γ EliSpots, anti-breast cancer cytotoxicity of peripheral blood mononuclear cells (PBMC) directed at breast cancer cell lines, Th1/Th2 serum cytokine patterns, and anti-breast cancer antibodies in the serum during the "vaccinate and consolidate" process
Time frame: Blood will be collected about 5 weeks before any treatment, just before first HER2 BATs infusion, before HER2 BATs #5, before HER2 BATs #8, and 2 weeks, 1 month, 3 months, and 6 months after last Pembrolizumab
Disease Control Rate
The percentage of subjects who achieve complete response, partial response and stable disease following treatment.
Time frame: Imaging will be done prior to study treatment, 1 month, 3 months and 6 months after completion of study treatment. Imaging will then be performed according to standard of care.
Duration of Response
The time from documentation of tumor response to disease progression.
Time frame: Imaging will be done prior to study treatment, 1 month, 3 months and 6 months after completion of study treatment. Imaging will then be performed according to standard of care.
| Milestone | Phase 1: Schedule #1 | Phase 1: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule 3 |
|---|---|---|---|---|
| Started | 3 | 8 | 3 | 8 |
| Completed | 3 | 7 | 3 | 4 |
| Not completed | 0 | 1 | 0 | 4 |
| Withdrew: Never started cellular infusions | 0 | 1 | 0 | 4 |
Maximum tolerated dose will be based on number of dose limiting toxicities in each schedule/arm
| participants | Phase 1: Schedule #1 | Phase 1: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule #3 |
|---|---|---|---|---|
| Dose Limiting Toxicities (Escalation and Expansion Cohorts) | 0 | 1 | 0 | 0 |
Dose Limiting toxicities on the arm selected based on the dose/schedule selection part of the study.
| Participants | Phase 1: Schedule #1 | Phase 1: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule #3 |
|---|---|---|---|---|
| Dose Limiting Toxicities on the Selected Arm in the Expansion Cohort | 0 | 0 | 0 | 0 |
The percentage of subjects with a response of complete response (CR) or partial response (PR) per immune related response criteria (irRC)
Results for this outcome have not been posted.
Time from enrollment until death from any cause
| days | Phase 1: Schedule #1 | Phase 1: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule #3 |
|---|---|---|---|---|
| Overall Survival | 687 ± 224 | 677 ± 547 | 547 ± 406 | 405 ± 339 |
Time from enrollment to time of first progression after enrollment (days)
| days | Phase 1: Schedule #1 | Phase 1: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule 3 |
|---|---|---|---|---|
| Progression-Free Survival | 146 ± 52.2 | 173 ± 218 | 280 ± 247 | 152 ± 113 |
Sequential monitoring of phenotype, IFN-γ EliSpots, anti-breast cancer cytotoxicity of peripheral blood mononuclear cells (PBMC) directed at breast cancer cell lines, Th1/Th2 serum cytokine patterns, and anti-breast cancer antibodies in the serum during the "vaccinate and consolidate" process
Results for this outcome have not been posted.
The percentage of subjects who achieve complete response, partial response and stable disease following treatment.
Results for this outcome have not been posted.
The time from documentation of tumor response to disease progression.
Results for this outcome have not been posted.
Collected over From enrollment to 30 days after last treatment, up to 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1: Schedule #1 | 3/3 (100%) | 1/3 (33.3%) | 3/3 (100%) |
| Phase 2: Schedule #2 | 7/7 (100%) | 1/7 (14.3%) | 7/7 (100%) |
| Phase 1: Schedule #3 | 3/3 (100%) | 0/3 (0%) | 3/3 (100%) |
| Phase 2: Schedule #3 | 4/4 (100%) | 2/4 (50%) | 4/4 (100%) |
| Event | Phase 1: Schedule #1 | Phase 2: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule #3 |
|---|---|---|---|---|
| HypotensionVascular disorders | 1/3 | 1/7 | 0/3 | 1/4 |
| ConfusionNervous system disorders | 1/3 | 0/7 | 0/3 | 0/4 |
| TachycardiaCardiac disorders | 1/3 | 0/7 | 0/3 | 1/4 |
| BronchospasmRespiratory, thoracic and mediastinal disorders | 0/3 | 0/7 | 0/3 | 1/4 |
| alanine aminotransferase elevationGastrointestinal disorders | 0/3 | 1/7 | 0/3 | 0/4 |
| HypertensionVascular disorders | 0/3 | 1/7 | 0/3 | 0/4 |
| Event | Phase 1: Schedule #1 | Phase 2: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule #3 |
|---|---|---|---|---|
| HypotensionVascular disorders | 1/3 | 7/7 | 3/3 | 4/4 |
| chillsGeneral disorders | 1/3 | 3/7 | 3/3 | 4/4 |
| HeadacheNervous system disorders | 3/3 | 5/7 | 2/3 | 1/4 |
| nauseaGastrointestinal disorders | 2/3 | 3/7 | 3/3 | 3/4 |
| anemiaBlood and lymphatic system disorders | 3/3 | 2/7 | 0/3 | 3/4 |
| hypertensionVascular disorders | 3/3 | 7/7 | 1/3 | 4/4 |
| vomitingGastrointestinal disorders | 2/3 | 2/7 | 3/3 | 1/4 |
| sinus tachycardiaCardiac disorders | 2/3 | 6/7 | 0/3 | 2/4 |
| feverGeneral disorders | 1/3 | 5/7 | 2/3 | 1/4 |
| hypercalcemiaInvestigations | 0/3 | 1/7 | 2/3 | 2/4 |
| Age, Customized(years) | Phase 1: Schedule #1 | Phase 1: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule #3 | Total |
|---|---|---|---|---|---|
| Median (SD) | 64.7 ± 13.7 | 51.5 ± 16.8 | 56.2 ± 10.2 | 53.3 ± 11.9 | 54.6 ± 13.7 |
| Sex: Female, Male(Participants) | Phase 1: Schedule #1 | Phase 1: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule #3 | Total |
|---|---|---|---|---|---|
| Female | 3 | 8 | 3 | 8 | 22 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1: Schedule #1 | Phase 1: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule #3 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 1 | 2 |
| Not Hispanic or Latino | 3 | 7 | 3 | 7 | 20 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Phase 1: Schedule #1 | Phase 1: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule #3 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 1 | 1 |
| White | 3 | 8 | 3 | 7 | 21 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Phase 1: Schedule #1 | Phase 1: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule #3 | Total |
|---|---|---|---|---|---|
| United States | 3 | 8 | 3 | 8 | 22 |
| ECOG Performance status(units on a scale) | Phase 1: Schedule #1 | Phase 1: Schedule #2 | Phase 1: Schedule #3 | Phase 2: Schedule #3 | Total |
|---|---|---|---|---|---|
| Mean | 1.2 (0 to 2) | 1.3 (0 to 2) | 1.2 (0 to 2) | 1.2 (0 to 2) | 1.2 (0 to 2) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Nov 2024, 83 months.
Results were first posted in Feb 2026, 1 year 2 months after primary completion.
Of 166 non-industry phase 1/2 interventional studies under Breast Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 95. This study's 83 months is above that.
Counting every sponsor, half of 327 studies reached it within 61 months; a quarter within 45 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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