TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery
NCT ID: NCT04197687
Last Updated: 2023-12-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
480 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-02-20
Study Completion Date
2025-01-15
Brief Summary
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This phase II trial studies how well TPIV100 and sargramostim work in treating patients with HER2 positive, stage II-III breast cancer that has residual disease after chemotherapy prior to surgery. It also studies why some HER2 positive breast cancer patients respond better to chemotherapy in combination with trastuzumab and pertuzumab. TPIV100 is a type of vaccine made from HER2 peptide that may help the body build an effective immune response to kill tumor cells that express HER2. Sargramostim increases the number of white blood cells in the body following chemotherapy for certain types of cancer and is used to alert the immune system. It is not yet known if TPIV100 and sargramostim will work better in treating patients with HER2 positive, stage II-III breast cancer.
Detailed Description
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PRIMARY OBJECTIVES:
I. To evaluate invasive disease free survival (iDFS) of multi-epitope HER2 vaccine versus (vs.) placebo in combination with ado-trastuzumab emtansine (TTT-DM1) in patients with stage II-III HER2 positive (+) breast cancer (BC) with residual disease post-neoadjuvant chemotherapy.
II. To evaluate the safety of multi-epitope HER2 vaccine given concurrently with ado-trastuzumab emtansine (T-DM1) maintenance therapy.
SECONDARY OBJECTIVES:
I. To evaluate immunogenicity of multi-epitope HER2 vaccine in combination with T-DM1 maintenance therapy.
II. To evaluate the immune-related tissue and blood biomarkers for complete pathological response in patients with stage II-III HER2+ BC receiving neoadjuvant chemotherapy.
CORRELATIVE RESEARCH OBJECTIVES:
I. To determine host immune factors which are critical to prevent disease recurrence in HER2+ BC patients.
Ia. To determine if the development of T cell immunity, as assessed by IFN-gamma enzyme-linked immunospot (ELISpot), to HER2 correlates with improved iDFS.
Ib. To determine the distribution of the helper T cell response among helper T cell differentiation states.
Ic. To determine if augmenting CD4 helper T cell immunity augments HER2-specific antibody immunity induced by trastuzumab.
Id. To determine if human leukocyte antigen (HLA) genotypes are associated with antibody responses before and after neoadjuvant therapy and vaccination.
Ie. To determine gene expression levels in tumors from patients who did not achieve complete pathological response (pCR) that are associated with recurrence.
II. To determine tumor intrinsic genotyping and phenotyping features associated with therapeutic failure to HER2 immune-based approaches.
IIa. To determine whether HER2 monoclonal antibody therapy induces HER2 loss and modulation of HER2-specific adaptive immune responses.
IIb. To determine loss-of-function mutations in breast tumor that associate with lack of pCR and lack of immune response to HER2+ neoadjuvant treatment.
OUTLINE:
pCR AFTER NEOADJUVANT CHEMOTHERAPY AND SURGERY: Patients receive standard of care maintenance therapy with trastuzumab and pertuzumab for 1 year in the absence of disease progression or unacceptable toxicity.
NO pCR AFTER NEOADJUVANT CHEMOTHERAPY AND SURGERY: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care maintenance therapy with trastuzumab emtansine and receive TPIV100 intradermally (ID) and sargramostim ID on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive two additional booster injections of TPIV100 ID and sargramostim ID at 3 and 12 months after completion of trastuzumab emtansine maintenance therapy.
ARM 2: Patients receive standard of care maintenance therapy with trastuzumab emtansine and receive placebo intradermally (ID) and sargramostim ID on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive two additional booster injections of placebo ID and sargramostim ID at 3 and 12 months after completion of trastuzumab emtansine maintenance therapy.
I. To evaluate invasive disease free survival (iDFS) of multi-epitope HER2 vaccine versus (vs.) placebo in combination with ado-trastuzumab emtansine (TTT-DM1) in patients with stage II-III HER2 positive (+) breast cancer (BC) with residual disease post-neoadjuvant chemotherapy.
II. To evaluate the safety of multi-epitope HER2 vaccine given concurrently with ado-trastuzumab emtansine (T-DM1) maintenance therapy.
SECONDARY OBJECTIVES:
I. To evaluate immunogenicity of multi-epitope HER2 vaccine in combination with T-DM1 maintenance therapy.
II. To evaluate the immune-related tissue and blood biomarkers for complete pathological response in patients with stage II-III HER2+ BC receiving neoadjuvant chemotherapy.
CORRELATIVE RESEARCH OBJECTIVES:
I. To determine host immune factors which are critical to prevent disease recurrence in HER2+ BC patients.
Ia. To determine if the development of T cell immunity, as assessed by IFN-gamma enzyme-linked immunospot (ELISpot), to HER2 correlates with improved iDFS.
Ib. To determine the distribution of the helper T cell response among helper T cell differentiation states.
Ic. To determine if augmenting CD4 helper T cell immunity augments HER2-specific antibody immunity induced by trastuzumab.
Id. To determine if human leukocyte antigen (HLA) genotypes are associated with antibody responses before and after neoadjuvant therapy and vaccination.
Ie. To determine gene expression levels in tumors from patients who did not achieve complete pathological response (pCR) that are associated with recurrence.
II. To determine tumor intrinsic genotyping and phenotyping features associated with therapeutic failure to HER2 immune-based approaches.
IIa. To determine whether HER2 monoclonal antibody therapy induces HER2 loss and modulation of HER2-specific adaptive immune responses.
IIb. To determine loss-of-function mutations in breast tumor that associate with lack of pCR and lack of immune response to HER2+ neoadjuvant treatment.
OUTLINE:
pCR AFTER NEOADJUVANT CHEMOTHERAPY AND SURGERY: Patients receive standard of care maintenance therapy with trastuzumab and pertuzumab for 1 year in the absence of disease progression or unacceptable toxicity.
NO pCR AFTER NEOADJUVANT CHEMOTHERAPY AND SURGERY: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care maintenance therapy with trastuzumab emtansine and receive TPIV100 intradermally (ID) and sargramostim ID on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive two additional booster injections of TPIV100 ID and sargramostim ID at 3 and 12 months after completion of trastuzumab emtansine maintenance therapy.
ARM 2: Patients receive standard of care maintenance therapy with trastuzumab emtansine and receive placebo intradermally (ID) and sargramostim ID on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive two additional booster injections of placebo ID and sargramostim ID at 3 and 12 months after completion of trastuzumab emtansine maintenance therapy.
Conditions
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Breast Adenocarcinoma
Stage II Breast Cancer AJCC v6 and v7
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Stage III Breast Cancer AJCC v7
Stage IIIA Breast Cancer AJCC v7
Stage IIIB Breast Cancer AJCC v7
Stage IIIC Breast Cancer AJCC v7
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Caregivers
Study Groups
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Treatment (pCR)
Patients receive standard of care maintenance therapy with trastuzumab and pertuzumab for 1 year in the absence of disease progression or unacceptable toxicity.
Group Type
EXPERIMENTAL
Pertuzumab
Intervention Type
BIOLOGICAL
permitted at physician's discretion
Trastuzumab
Intervention Type
BIOLOGICAL
therapy are at the discretion of the treating physicians
Arm I - No pCR (trastuzumab emtansine, TPIV100, sargramostim)
Patients receive standard of care maintenance therapy with trastuzumab emtansine and receive TPIV100 ID and sargramostim ID on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive two additional booster injections of TPIV100 ID and sargramostim ID at 3 and 12 months after completion of trastuzumab emtansine maintenance therapy.
Group Type
EXPERIMENTAL
Multi-epitope HER2 Peptide Vaccine TPIV100
Intervention Type
BIOLOGICAL
Given ID
Sargramostim
Intervention Type
BIOLOGICAL
Given ID
Trastuzumab Emtansine
Intervention Type
BIOLOGICAL
at the discretion of the treating physicians.
Arm II - No pCR (trastuzumab emtansine, placebo, sargramostim)
Patients receive standard of care maintenance therapy with trastuzumab emtansine and receive placebo ID and sargramostim ID on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive two additional booster injections of placebo ID and sargramostim ID at 3 and 12 months after completion of trastuzumab emtansine maintenance therapy.
Group Type
PLACEBO_COMPARATOR
Placebo Administration
Intervention Type
OTHER
Given ID
Sargramostim
Intervention Type
BIOLOGICAL
Given ID
Trastuzumab Emtansine
Intervention Type
BIOLOGICAL
at the discretion of the treating physicians.
Interventions
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Multi-epitope HER2 Peptide Vaccine TPIV100
Given ID
Intervention Type
BIOLOGICAL
Pertuzumab
permitted at physician's discretion
Intervention Type
BIOLOGICAL
Placebo Administration
Given ID
Intervention Type
OTHER
Sargramostim
Given ID
Intervention Type
BIOLOGICAL
Trastuzumab
therapy are at the discretion of the treating physicians
Intervention Type
BIOLOGICAL
Trastuzumab Emtansine
at the discretion of the treating physicians.
Intervention Type
BIOLOGICAL
Other Intervention Names
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HER2/Neu Peptide Vaccine TPIV100
Peptide Vaccine TPIV100
TPIV 100
TPIV-100
TPIV100
2C4
2C4 Antibody
HS627
MoAb 2C4
Monoclonal Antibody 2C4
Omnitarg
Perjeta
Pertuzumab Biosimilar HS627
rhuMAb2C4
RO4368451
23-L-Leucinecolony-Stimulating Factor 2
DRG-0012
Leukine
Prokine
rhu GM-CFS
Sagramostim
Sargramostatin
ABP 980
ALT02
Anti-c-ERB-2
Anti-c-erbB2 Monoclonal Antibody
Anti-ERB-2
Anti-erbB-2
Anti-erbB2 Monoclonal Antibody
Anti-HER2/c-erbB2 Monoclonal Antibody
Anti-p185-HER2
c-erb-2 Monoclonal Antibody
HER2 Monoclonal Antibody
Herceptin
Herceptin Biosimilar PF-05280014
Herceptin Trastuzumab Biosimilar PF-05280014
Herzuma
Kanjinti
MoAb HER2
Monoclonal Antibody c-erb-2
Monoclonal Antibody HER2
Ogivri
Ontruzant
PF-05280014
rhuMAb HER2
RO0452317
SB3
Trastuzumab Biosimilar ABP 980
Trastuzumab Biosimilar ALT02
trastuzumab biosimilar EG12014
Trastuzumab Biosimilar HLX02
Trastuzumab Biosimilar PF-05280014
Trastuzumab Biosimilar SB3
Trastuzumab Biosimilar SIBP-01
Trastuzumab-anns
Trastuzumab-dkst
Trastuzumab-dttb
Trastuzumab-pkrb
Trastuzumab-qyyp
Trazimera
Ado Trastuzumab Emtansine
ADO-Trastuzumab Emtansine
Kadcyla
PRO132365
RO5304020
T-DM1
Trastuzumab-DM1
Trastuzumab-MCC-DM1
Trastuzumab-MCC-DM1 Antibody-Drug Conjugate
Trastuzumab-MCC-DM1 Immunoconjugate
Eligibility Criteria
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Inclusion Criteria
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Histologically confirmed adenocarcinoma of the breast stage \>= T2 OR \>= N1 based on the 7th edition of tumor, node, metastases (TNM) staging system from the American Joint Committee on Cancer
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Any estrogen receptor (ER) or progesterone receptor (PR) but HER2 positive defined as 3+ staining intensity (on a scale of 0 to 3) by means of immunohistochemistry (IHC) analysis OR gene amplification on fluorescence in situ hybridization (FISH) ratio \>= 2.0
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Willingness to provide adequate pretreatment biopsy sample
* NOTE: Adequate tissue samples defined as core needle biopsy or incisional biopsy or excisional samples that can provide \>= 3 core needle biopsies with at least 14 gauge (G) needle with 12 unstained sections of 5 micron thickness. Fine needle aspiration (FNA) sample alone is not sufficient
* NOTE: Patients without adequate pretreatment biopsy samples must be agreeable to have an additional research biopsy prior to neoadjuvant therapy
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Willing to employ adequate contraception from the time of pre-registration through 6 months after the final vaccine cycle
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Willing to receive a tetanus vaccination if subject has not had one =\< 1 year prior to pre-registration
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Provide written informed consent
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Willing to provide mandatory tissue and blood samples for correlative research purposes
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Negative pregnancy test done =\< 7 days prior to pre-registration, for persons of childbearing potential only
* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* REGISTRATION (SAFETY LEAD-IN): Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Platelet count \>= 75,000/mm\^3 (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Hemoglobin \>= 9.0 g/dL (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Direct bilirubin \< 1.5 x upper limit of normal (ULN) (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Creatinine =\< 2 x ULN (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Prothrombin time (PT)/international normalized ratio (INR)/ partial thromboplastin time (PTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulant (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Completed planned curative breast surgeries (not including any future breast reconstructive surgery) and any radiation therapy \>= 30 days prior to registration
* REGISTRATION (SAFETY LEAD-IN): Completed last cycle of chemotherapy \>= 90 days prior to registration
* NOTE: Prior to registration, patients must not receive \> 8 cycles of TDM-1 maintenance therapy after surgery
* REGISTRATION (SAFETY LEAD-IN): Any residual disease after trastuzumab +/- pertuzumab based neoadjuvant chemotherapy warranted T-DM1 as per treating physician
* REGISTRATION (SAFETY LEAD-IN): Adequate tissue specimens from both pre-treatment biopsy and surgery must be submitted. Adequate tissue samples defined as core needle biopsy or incisional biopsy or excisional samples that can provide \>= 3 core needle biopsies with at least 14G needle with 12 unstained sections of 5 micron thickness
* NOTE: Fine needle aspiration (FNA) sample alone is not sufficient
* REGISTRATION (SAFETY LEAD-IN): Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* REGISTRATION (SAFETY LEAD-IN): ECOG performance status (PS) 0, 1, 2
* REGISTRATION (SAFETY LEAD-IN): Willing to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): ECOG performance status (PS) 0, 1, 2
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Platelet count \>= 75,000/mm\^3 (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Hemoglobin \>= 9.0 g/dL (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Direct bilirubin \< 1.5 x upper limit of normal (ULN) (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Calculated serum creatinine clearance of \>= 50 mL/minute (min.) (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): PT/INR/PTT =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulants (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Negative pregnancy test done =\< 7 days prior to registration, for person of childbearing potential
* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Platelet count \>= 75,000/mm\^3 (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Hemoglobin \>= 9.0 g/dL (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Direct bilirubin \< 1.5 x upper limit of normal (ULN) (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Creatinine =\< 2 x ULN (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): PT/INR/PTT =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulant (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Completed last cycle of chemotherapy \>= 90 days prior to randomization
* NOTE: Prior to randomization, patients must not receive \>= 6 cycles of T-DM1 maintenance therapy after surgery
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Have residual disease with \>= 1 cm residual tumor in the breast (\>= ypT1c) and/or persistent lymph node positivity after trastuzumab +/- pertuzumab based neoadjuvant chemotherapy
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Adequate tissue specimens from both pre-treatment biopsy and surgery must be submitted. Adequate tissue samples defined as core needle biopsy or incisional biopsy or excisional samples that can provide \>= 3 core needle biopsies with at least 14G needle with 12 unstained sections of 5 micron thickness
* NOTE: Fine needle aspiration (FNA) sample alone is not sufficient
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Negative pregnancy test done =\< 7 days prior to randomization, for persons of childbearing potential only
* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): ECOG performance status (PS) 0, 1, 2
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Willing to employ adequate contraception from the time of randomization through 6 months after the final vaccine cycle
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Any estrogen receptor (ER) or progesterone receptor (PR) but HER2 positive defined as 3+ staining intensity (on a scale of 0 to 3) by means of immunohistochemistry (IHC) analysis OR gene amplification on fluorescence in situ hybridization (FISH) ratio \>= 2.0
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Willingness to provide adequate pretreatment biopsy sample
* NOTE: Adequate tissue samples defined as core needle biopsy or incisional biopsy or excisional samples that can provide \>= 3 core needle biopsies with at least 14 gauge (G) needle with 12 unstained sections of 5 micron thickness. Fine needle aspiration (FNA) sample alone is not sufficient
* NOTE: Patients without adequate pretreatment biopsy samples must be agreeable to have an additional research biopsy prior to neoadjuvant therapy
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Willing to employ adequate contraception from the time of pre-registration through 6 months after the final vaccine cycle
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Willing to receive a tetanus vaccination if subject has not had one =\< 1 year prior to pre-registration
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Provide written informed consent
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Willing to provide mandatory tissue and blood samples for correlative research purposes
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Negative pregnancy test done =\< 7 days prior to pre-registration, for persons of childbearing potential only
* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* REGISTRATION (SAFETY LEAD-IN): Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Platelet count \>= 75,000/mm\^3 (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Hemoglobin \>= 9.0 g/dL (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Direct bilirubin \< 1.5 x upper limit of normal (ULN) (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Creatinine =\< 2 x ULN (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Prothrombin time (PT)/international normalized ratio (INR)/ partial thromboplastin time (PTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulant (obtained =\< 28 days prior to registration)
* REGISTRATION (SAFETY LEAD-IN): Completed planned curative breast surgeries (not including any future breast reconstructive surgery) and any radiation therapy \>= 30 days prior to registration
* REGISTRATION (SAFETY LEAD-IN): Completed last cycle of chemotherapy \>= 90 days prior to registration
* NOTE: Prior to registration, patients must not receive \> 8 cycles of TDM-1 maintenance therapy after surgery
* REGISTRATION (SAFETY LEAD-IN): Any residual disease after trastuzumab +/- pertuzumab based neoadjuvant chemotherapy warranted T-DM1 as per treating physician
* REGISTRATION (SAFETY LEAD-IN): Adequate tissue specimens from both pre-treatment biopsy and surgery must be submitted. Adequate tissue samples defined as core needle biopsy or incisional biopsy or excisional samples that can provide \>= 3 core needle biopsies with at least 14G needle with 12 unstained sections of 5 micron thickness
* NOTE: Fine needle aspiration (FNA) sample alone is not sufficient
* REGISTRATION (SAFETY LEAD-IN): Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* REGISTRATION (SAFETY LEAD-IN): ECOG performance status (PS) 0, 1, 2
* REGISTRATION (SAFETY LEAD-IN): Willing to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): ECOG performance status (PS) 0, 1, 2
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Platelet count \>= 75,000/mm\^3 (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Hemoglobin \>= 9.0 g/dL (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Direct bilirubin \< 1.5 x upper limit of normal (ULN) (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Calculated serum creatinine clearance of \>= 50 mL/minute (min.) (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): PT/INR/PTT =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulants (obtained =\< 28 days prior to registration)
* REGISTRATION - FOR PATIENTS WITH NO RESIDUAL DISEASE (pCR) - (PHASE II): Negative pregnancy test done =\< 7 days prior to registration, for person of childbearing potential
* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Platelet count \>= 75,000/mm\^3 (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Hemoglobin \>= 9.0 g/dL (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Direct bilirubin \< 1.5 x upper limit of normal (ULN) (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Creatinine =\< 2 x ULN (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): PT/INR/PTT =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulant (obtained =\< 28 days prior to randomization)
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Completed last cycle of chemotherapy \>= 90 days prior to randomization
* NOTE: Prior to randomization, patients must not receive \>= 6 cycles of T-DM1 maintenance therapy after surgery
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Have residual disease with \>= 1 cm residual tumor in the breast (\>= ypT1c) and/or persistent lymph node positivity after trastuzumab +/- pertuzumab based neoadjuvant chemotherapy
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Adequate tissue specimens from both pre-treatment biopsy and surgery must be submitted. Adequate tissue samples defined as core needle biopsy or incisional biopsy or excisional samples that can provide \>= 3 core needle biopsies with at least 14G needle with 12 unstained sections of 5 micron thickness
* NOTE: Fine needle aspiration (FNA) sample alone is not sufficient
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Negative pregnancy test done =\< 7 days prior to randomization, for persons of childbearing potential only
* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): ECOG performance status (PS) 0, 1, 2
* RANDOMIZATION - PATIENTS WITH RESIDUAL DISEASE POST NEOADJUVANT TRATUZUMAB +/- PERTUZUMAB BASED CHEMOTHERAPY (NO pCR) - (PHASE II): Willing to employ adequate contraception from the time of randomization through 6 months after the final vaccine cycle
Exclusion Criteria
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): 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 person
* Nursing person unwilling to stop breast feeding
* Person of child bearing potential who are unwilling to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Clinical evidence of active local recurrence or distant metastases
* NOTE: All patients must have either a positron emission tomography (PET)/computed tomography (CT) or CT chest, abdomen, and pelvis with bone scan to rule out distant metastases =\< 365 days prior to preregistration. If any of these is concerning, follow-up imaging or biopsy should be performed if indicated rule out distant metastases
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids
* NOTE: Must be off systemic steroids at least 14 days prior to pre-registration. However, topical steroids, inhalants or steroid eye drops are permitted
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): 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
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Uncontrolled acute or chronic medical conditions including, but not limited to the following:
* Active infection requiring antibiotics
* Congestive heart failure with New York Heart Association class III or IV; moderate to severe objective evidence of cardiovascular disease
* Myocardial infarction or stroke =\< 6 months prior to pre-registration
* Significant cardiac arrhythmia or unstable angina
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Receiving any other investigational agent
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Other active malignancy at time of pre-registration or =\< 3 years prior to preregistration
* EXCEPTIONS: Non-melanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)
* NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (cytotoxics, monoclonal antibodies, small molecule inhibitors) for their cancer
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Known history of active autoimmune disease that has required systemic treatment in the =\< 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration. 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
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Any prior hypersensitivity or adverse reaction to granulocyte-macrophage colony stimulating factor (GM-CSF)
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): History of trastuzumab-related cardiac toxicity requiring interruption or discontinuation of therapy, even if left ventricular ejection fraction (LVEF) fully recovered
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Baseline LVEF \< 50%
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): History of myocardial infarction =\< 168 days (6 months) prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life threatening ventricular arrhythmias
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer =\< 2 months prior to pre-registration
* Pregnant person
* Nursing person unwilling to stop breast feeding
* Person of child bearing potential who are unwilling to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Clinical evidence of active local recurrence or distant metastases
* NOTE: All patients must have either a positron emission tomography (PET)/computed tomography (CT) or CT chest, abdomen, and pelvis with bone scan to rule out distant metastases =\< 365 days prior to preregistration. If any of these is concerning, follow-up imaging or biopsy should be performed if indicated rule out distant metastases
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids
* NOTE: Must be off systemic steroids at least 14 days prior to pre-registration. However, topical steroids, inhalants or steroid eye drops are permitted
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): 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
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Uncontrolled acute or chronic medical conditions including, but not limited to the following:
* Active infection requiring antibiotics
* Congestive heart failure with New York Heart Association class III or IV; moderate to severe objective evidence of cardiovascular disease
* Myocardial infarction or stroke =\< 6 months prior to pre-registration
* Significant cardiac arrhythmia or unstable angina
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Receiving any other investigational agent
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Other active malignancy at time of pre-registration or =\< 3 years prior to preregistration
* EXCEPTIONS: Non-melanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)
* NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (cytotoxics, monoclonal antibodies, small molecule inhibitors) for their cancer
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Known history of active autoimmune disease that has required systemic treatment in the =\< 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration. 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
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Any prior hypersensitivity or adverse reaction to granulocyte-macrophage colony stimulating factor (GM-CSF)
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): History of trastuzumab-related cardiac toxicity requiring interruption or discontinuation of therapy, even if left ventricular ejection fraction (LVEF) fully recovered
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Baseline LVEF \< 50%
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): History of myocardial infarction =\< 168 days (6 months) prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life threatening ventricular arrhythmias
* PRE-REGISTRATION FOR ALL PATIENTS (INCLUDE SAFETY LEAD-IN): Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer =\< 2 months prior to pre-registration
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Academic and Community Cancer Research United
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Saranya Chumsri
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Site Status
RECRUITING
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Site Status
RECRUITING
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Site Status
RECRUITING
Yuma Regional Medical Center
Yuma, Arizona, United States
Site Status
WITHDRAWN
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Site Status
WITHDRAWN
UC San Diego Moores Cancer Center
La Jolla, California, United States
Site Status
NOT_YET_RECRUITING
Middlesex Hospital
Middletown, Connecticut, United States
Site Status
WITHDRAWN
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States
Site Status
RECRUITING
Mayo Clinic in Florida
Jacksonville, Florida, United States
Site Status
RECRUITING
Cleveland Clinic Florida
West Palm Beach, Florida, United States
Site Status
WITHDRAWN
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Site Status
NOT_YET_RECRUITING
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Site Status
WITHDRAWN
Carle Cancer Center NCI Community Oncology Research Program
Urbana, Illinois, United States
Site Status
WITHDRAWN
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Site Status
WITHDRAWN
University Medical Center New Orleans
New Orleans, Louisiana, United States
Site Status
RECRUITING
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Site Status
NOT_YET_RECRUITING
Essentia Health NCI Community Oncology Research Program
Duluth, Minnesota, United States
Site Status
WITHDRAWN
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Site Status
RECRUITING
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Site Status
WITHDRAWN
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
WITHDRAWN
University of Nebraska Medical Center
Omaha, Nebraska, United States
Site Status
RECRUITING
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Site Status
RECRUITING
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
Site Status
RECRUITING
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States
Site Status
WITHDRAWN
Lexington Medical Center
West Columbia, South Carolina, United States
Site Status
WITHDRAWN
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Site Status
NOT_YET_RECRUITING
Inova Fairfax Hospital
Falls Church, Virginia, United States
Site Status
WITHDRAWN
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Site Status
NOT_YET_RECRUITING
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Site Status
WITHDRAWN
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States
Site Status
WITHDRAWN
Countries
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United States
Facility Contacts
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ACCRU Operations
Role: primary
Pavani Chalasani
Role: primary
ACCRU Operations
Role: primary
ACCRU Operations
Role: primary
Karen C. Daily
Role: primary
ACCRU Operations
Role: primary
Keerthi Gogineni
Role: primary
Jyotsna Fuloria
Role: primary
Katherine H. Tkaczuk
Role: primary
ACCRU Operations
Role: primary
Anita Rogic
Role: primary
Laurie Balch
Role: primary
Charles S. Kuzma
Role: primary
ACCRU Operations
Role: primary
ACCRU Operations
Role: primary
Other Identifiers
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NCI-2019-08038
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC1835-ACCRU-BR-1701
Identifier Type: OTHER
Identifier Source: secondary_id
MC1835-ACCRU-BR-1701
Identifier Type: -
Identifier Source: org_study_id