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Status unknownNCT04197687Updated Dec 18, 2023

TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery

A Phase 2 interventional study of Multi-epitope HER2 Peptide Vaccine TPIV100 and Pertuzumab in Breast Adenocarcinoma, Stage II Breast Cancer AJCC v6 and v7 and Stage IIA Breast Cancer AJCC v6 and v7, sponsored by Academic and Community Cancer Research United. Status unknown at 30 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by Academic and Community Cancer Research United · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • 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

Browse trials for

03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 480 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Academic and Community Cancer Research United is the lead sponsor of 50 studies on the registry; 5 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 12 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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.

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
480 participants (estimated)

Study arms

  • Experimental
    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.

    Biological: Multi-epitope HER2 Peptide Vaccine TPIV100 · Biological: Sargramostim · Biological: Trastuzumab Emtansine

  • Placebo comparator
    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.

    Other: Placebo Administration · Biological: Sargramostim · Biological: Trastuzumab Emtansine

  • Experimental
    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.

    Biological: Pertuzumab · Biological: Trastuzumab

Interventions

  • BiologicalMulti-epitope HER2 Peptide Vaccine TPIV100

    Given ID

    Also known as: HER2/Neu Peptide Vaccine TPIV100, Peptide Vaccine TPIV100, TPIV 100, TPIV-100, TPIV100

  • BiologicalPertuzumab

    permitted at physician's discretion

    Also known as: 2C4, 2C4 Antibody, HS627, MoAb 2C4, Monoclonal Antibody 2C4, Omnitarg, Perjeta, Pertuzumab Biosimilar HS627, rhuMAb2C4, RO4368451

  • OtherPlacebo Administration

    Given ID

  • BiologicalSargramostim

    Given ID

    Also known as: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin

  • BiologicalTrastuzumab

    therapy are at the discretion of the treating physicians

    Also known as: 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

  • BiologicalTrastuzumab Emtansine

    at the discretion of the treating physicians.

    Also known as: 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

06

What researchers measure

Primary outcomes

  1. Invasive disease-free survival (iDFS) between the 2 arms

    iDFS will be defined from the time of randomization to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause, contralateral invasive breast cancer, or second primary non-breast invasive cancer. Will be based on stratified log-rank test at one-sided 0.01 level in an intention-to-treat population, where the stratification is by the randomization stratification factors. The Cox proportional hazards model will be used to adjust for the trial stratification factors (hormone receptor, human leukocyte antigen A classification, status and clinical stage). Subgroup analyses of iDFS will also be performed by stratification factors and other baseline characteristics, with the caveat that statistical power for these subgroup analyses may be limited.

    Time frame: From time of randomization to recurrence, invasive breast cancer or death, assessed up to 5 years

Secondary outcomes

  1. Overall survival

    defined as the time from randomization to the date of death due to any cause. Patients who are lost to follow-up for OS will be censored at the date the subject was last known to be alive

    Time frame: From randomization to the date of death due to any cause, assessed up to 5 years

  2. Incidence of adverse events (AEs)

    Will be assessed according to Common Terminology Criteria for Adverse Events 5.0 and defined as adverse events that are classified as either unrelated, unlikely to be related, possibly, probably, or definitely related to the study treatment. 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. Frequency tables will be generated to summarize the occurrence of treatment-related AE's by treatment arms. Comparisons of the rates of individual AE's will be done using tests of proportions such as Fisher's exact test or Chi-squared test. Additional analysis will use the Cochran-Mantel-Haenszel chi-squared test with study stratification factors.

    Time frame: Up to 24 months

  3. Immunogenicity assessment

    To evaluate immunogenicity of multi-epitope HER2 vaccine in combination with T-DM1 maintenance therapy.

    Time frame: Up to 5 years

  4. Complete pathological response

    Will be assessed using immune-related tissue and blood biomarkers.

    Time frame: Baseline

  5. Vaccine induced HER2-specific T cell responses

    Will be defined as a 2-fold or greater increase in HER2-specific antibody concentration from pre-treatment levels at any point during treatment or HER2-specific antibodies above the lower limit of detection at any point during treatment if pre-treatment levels were non-detectable. Antibody response frequency at the post-treatment initiation time points will be compared among arms using a chi-squared test. Antibody response magnitude at the post-treatment initiation time point will be compared among arms using an analysis of variance F-test followed by Tukey pairwise comparisons between pairs of arms. Likelihood of antibody response at the post-treatment initiation time point will be compared among arms using logistic regression (the dependent variable is antibody response \[yes/no\] at the post-treatment initiation time point; the independent variables are the antibody response \[yes/no\] at the pre-treatment time point and a categorical variable capturing arm).

    Time frame: Baseline up to 24 months

07

Study locations

10 of 30 sites recruiting
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
    • ACCRU Operations · Contact · ACCRU@mayo.edu · 507-538-7448
    • Brenda J. Ernst · Principal investigator
    Recruiting
  • Banner University Medical Center - Tucson
    Tucson, Arizona 85719, United States
    Recruiting
  • University of Arizona Cancer Center-North Campus
    Tucson, Arizona 85719, United States
    • ACCRU Operations · Contact · ACCRU@mayo.edu · 507-538-7448
    • Pavani Chalasani · Principal investigator
    Recruiting
  • Yuma Regional Medical Center
    Yuma, Arizona 85364, United States
    Withdrawn
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
    Withdrawn
  • UC San Diego Moores Cancer Center
    La Jolla, California 92093, United States
    • ACCRU Operations · Contact · ACCRU@mayo.edu · 507-538-7459
    • Sarah G. Boles · Principal investigator
    Not yet recruiting
  • Middlesex Hospital
    Middletown, Connecticut 06457, United States
    Withdrawn
  • University of Florida Health Science Center - Gainesville
    Gainesville, Florida 32610, United States
    Recruiting
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
    • ACCRU Operations · Contact · ACCRU@mayo.edu · 507-538-7448
    • Saranya Chumsri · Principal investigator
    Recruiting
  • Cleveland Clinic Florida
    West Palm Beach, Florida 33401, United States
    Withdrawn
  • Emory University Hospital/Winship Cancer Institute
    Atlanta, Georgia 30322, United States
    Not yet recruiting
  • Illinois CancerCare-Peoria
    Peoria, Illinois 61615, United States
    Withdrawn
  • Carle Cancer Center NCI Community Oncology Research Program
    Urbana, Illinois 61801, United States
    Withdrawn
  • Siouxland Regional Cancer Center
    Sioux City, Iowa 51101, United States
    Withdrawn
  • University Medical Center New Orleans
    New Orleans, Louisiana 70112, United States
    Recruiting
  • University of Maryland/Greenebaum Cancer Center
    Baltimore, Maryland 21201, United States
    • Katherine H. Tkaczuk · Contact · ktkaczuk@umm.edu
    • Katherine H. Tkaczuk · Principal investigator
    Not yet recruiting
  • Essentia Health NCI Community Oncology Research Program
    Duluth, Minnesota 55805, United States
    Withdrawn
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    • ACCRU Operations · Contact · ACCRU@mayo.edu · 507-538-7448
    • Kathryn J. Ruddy · Principal investigator
    Recruiting
  • Coborn Cancer Center at Saint Cloud Hospital
    Saint Cloud, Minnesota 56303, United States
    Withdrawn
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    Withdrawn
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
    • Anita Rogic · Contact · arogic@unmc.edu · 402-559-5524
    • Jairam Krishnamurthy, MD · Principal investigator
    Recruiting
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    Lebanon, New Hampshire 03756, United States
    Recruiting
  • FirstHealth of the Carolinas-Moore Regional Hospital
    Pinehurst, North Carolina 28374, United States
    • Charles S. Kuzma · Contact · ckuzma@firsthealth.org · 507-538-7448
    • Charles S. Kuzma · Principal investigator
    Recruiting
  • Guthrie Medical Group PC-Robert Packer Hospital
    Sayre, Pennsylvania 18840, United States
    Withdrawn
  • Lexington Medical Center
    West Columbia, South Carolina 29169, United States
    Withdrawn
  • Vanderbilt University/Ingram Cancer Center
    Nashville, Tennessee 37232, United States
    • ACCRU Operations · Contact · ACCRU@mayo.edu · 507-538-7448
    • Vandana G. Abramson · Principal investigator
    Not yet recruiting
  • Inova Fairfax Hospital
    Falls Church, Virginia 22042, United States
    Withdrawn
  • Marshfield Medical Center-EC Cancer Center
    Eau Claire, Wisconsin 54701, United States
    • ACCRU Operations · Contact · ACCRU@mayo.edu · 507-538-7448
    • Arlene A. Gayle · Principal investigator
    Not yet recruiting
  • Saint Vincent Hospital Cancer Center Green Bay
    Green Bay, Wisconsin 54301, United States
    Withdrawn
  • Dean Hematology and Oncology Clinic
    Madison, Wisconsin 53717, United States
    Withdrawn
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2020 (actual). Primary completion is estimated for Jan 2025, 58 months after the start.

Of 983 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 85. This study's planned 58 months is close to that.

Counting every sponsor, half of 1,201 studies reached it within 49 months; a quarter within 31 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2019
First posted
Dec 13, 2019
StartActual
Feb 20, 2020
Primary completionEst.
Jan 15, 2025
CompletionEst.
Jan 15, 2025
Last update
Dec 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04197687
Lead sponsor
Academic and Community Cancer Research United
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Dec 13, 2019
Start date
Feb 20, 2020
Primary completion
Jan 15, 2025 (estimated)
Completion
Jan 15, 2025 (estimated)
Last update
Dec 18, 2023

Study contacts

Saranya Chumsri
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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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.

Studies of the drugs tested here: Sargramostim · Trastuzumab

Other studies in this condition

Breast Neoplasms →

Other studies from this sponsor

Academic and Community Cancer Research United

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