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NCT02938442

Vaccination of Triple Negative Breast Cancer Patients

Completed Phase 1, PHASE2 Results posted Last updated 7 November 2024
What this trial tests

Phase 1, PHASE2 trial testing P10s-PADRE with MONTANIDE™ ISA 51 VG in Triple Negative Breast Cancer in 16 participants. Completed in 9 January 2023.

Timeline
25 January 2019
Primary endpoint
9 January 2023
9 January 2023

Quick facts

Lead sponsorUniversity of Arkansas
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment16
Start date25 January 2019
Primary completion9 January 2023
Estimated completion9 January 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Arkansas

Who can join

18 and older, female only, with Triple Negative Breast Cancer or Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety and Tolerability Adverse Events Primary · From the start of treatment to the time of definitive surgery (4-8 weeks after chemo); from Week 0 to Week 20-23

A Safety/Tolerability Event is defined as the occurrence of one of the following: * A Serious Adverse Event, OR * A non-Serious Adverse Event of Grade = 3, 4, or 5, OR * A non-Serious Adverse Event of Grade = 2 whose Relationship to P10s-PADRE Vaccine was classified as Definite, Probable, or Possible

GroupValue95% CI
Chemotherapy Only8
Chemo+Vaccine81
Pathologic Complete Response (pCR) Primary · During and/or Immediately After Surgery

A tumor-response call of either ypT0N0 or ypTisN0 determined through surgical staging after neoadjuvant therapy. The staging system used to determine the tumor-response call is the AJCC Staging System described in a 2014 FDA Guidance for Industry. • A tumor-response call of "pyT0N0" is also equated with pCR in the published literature.

GroupValue95% CI
Chemotherapy Only1
Chemo+Vaccine2
Chemotherapy Only4
Chemo+Vaccine9
Pathological Tumor Size Primary · Surgery

Tumor size at surgery/pathology report

GroupValue95% CI
Chemotherapy Only3.52± 5.65
Chemo+Vaccine0.98± 0.85
Pathological Node Status: Number of Positive Lymph Nodes Primary · Surgery

Number of positive lymph nodes found out of dissected lymph nodes

GroupValue95% CI
Chemotherapy Only6.6± 14.76
Chemo+Vaccine1.5± 3.46
Pathological Node Status: Number of Dissected Lymph Nodes Primary · Surgery

Number of dissected lymph nodes at surgery for study participants

GroupValue95% CI
Chemotherapy Only10.2± 14.06
Chemo+Vaccine6.91± 5.74
Tumor Response Primary · Surgery

Participants had their tumors surgically removed and pathologically staged using the AJCC Staging criteria. The main method of pathologic staging for breast cancer is the TNM system which stands for (Tumor size, lymph Node status and Metastases). "yp" prior to TN means the tissue was staged after neoadjuvant therapy. The larger the number after "T" means the larger the size, and the larger the number after "N" means the number of affected nearby lymph nodes. Therefore, tumor gradings with T3Nx are worse than those with T0Nx. The two categories "pyT0N0" and "ypT0N0" are both considered to be sy

GroupValue95% CI
Chemotherapy Only0
Chemo+Vaccine1
Chemotherapy Only0
Chemo+Vaccine1
Chemotherapy Only0
Chemo+Vaccine1
Chemotherapy Only0
Chemo+Vaccine1
Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers Secondary · Weeks 7, 10, 15, 18, 23, 46, and 70

The anti-P10s binding level was measured via ELISA method after incubation with a subject's serum samples. The endpoint titer was determined for each serum sample, and then fold change in endpoint titer in post-treatment weeks compared to pre-treatment week (Week 1) were calculated.

Week 7
GroupValue95% CI
Chemotherapy Only1± 0
Chemo+Vaccine2.27± 2.83
Week 10
GroupValue95% CI
Chemo+Vaccine3± 4.80
Week 15
GroupValue95% CI
Chemo+Vaccine1.73± 2.1
Week 18
GroupValue95% CI
Chemo+Vaccine1.36± 0.92
Week 23
GroupValue95% CI
Chemo+Vaccine1.55± 1.21
Week 46
GroupValue95% CI
Chemotherapy Only1± 0
Chemo+Vaccine5.4± 9.45
Week 70
GroupValue95% CI
Chemo+Vaccine6.25± 10.69
Frequencies of NK Cells - CD16 Secondary · Week 1, 7, 10, 15, 18, 23, 46, 70

Using flow cytometry, the frequencies of NK cells were determined for samples collected from multiple timepoints from Week 1 to Week 70. Values were averaged for the percent of CD16+NK cells.

Week 1
GroupValue95% CI
Chemotherapy Only76.89± 39.81
Chemo+Vaccine90.57± 4.87
Week 7
GroupValue95% CI
Chemotherapy Only66.72± 32.41
Chemo+Vaccine87.36± 5.84
Week 10
GroupValue95% CI
Chemo+Vaccine69.96± 15.09
Week 15
GroupValue95% CI
Chemo+Vaccine83.38± 7.82
Week 18
GroupValue95% CI
Chemo+Vaccine87.79± 6.7
Week 23
GroupValue95% CI
Chemo+Vaccine80.9± 5
Week 46
GroupValue95% CI
Chemotherapy Only94.2± 2.63
Chemo+Vaccine82.91± 9.51
Week 70
GroupValue95% CI
Chemo+Vaccine96.64± 6.92
Frequencies of NK Cells - CD69 Secondary · Weeks 1, 7, 10, 15, 18, 23, 46, and 70

Using flow cytometry, the frequencies of NK cells were determined for samples collected from multiple timepoints from Week 1 to Week 70. Values were averaged for the percent of CD69+NK cells.

Week 1
GroupValue95% CI
Chemotherapy Only5.19± 2.06
Chemo+Vaccine7.89± 5.98
Week 7
GroupValue95% CI
Chemotherapy Only3.64± 1.71
Chemo+Vaccine13.54± 5.28
week 10
GroupValue95% CI
Chemo+Vaccine5.98± 2.49
Week 15
GroupValue95% CI
Chemo+Vaccine15.73± 27.88
Week 18
GroupValue95% CI
Chemo+Vaccine9.52± 7.28
Week 23
GroupValue95% CI
Chemo+Vaccine11.21± 8.7
Week 46
GroupValue95% CI
Chemotherapy Only2.93± 1.21
Chemo+Vaccine6.14± 3.35
Week 70
GroupValue95% CI
Chemo+Vaccine3.98± 1.97
Frequencies of NK Cells - NKp46 Secondary · Weeks 1, 7, 10, 15, 18, 23, 46, and 70

Using flow cytometry, the frequencies of NK cells were determined for samples collected from multiple timepoints from Week 1 to Week 70. Values were averaged for the percent of NKp46+NK cells.

Week 1
GroupValue95% CI
Chemotherapy Only87.98± 13.41
Chemo+Vaccine77.98± 29.16
Week 7
GroupValue95% CI
Chemotherapy Only73.64± 25.66
Chemo+Vaccine83.36± 16.84
Week 10
GroupValue95% CI
Chemo+Vaccine70.35± 27.32
Week 15
GroupValue95% CI
Chemo+Vaccine87.77± 11.01
Week 18
GroupValue95% CI
Chemo+Vaccine90.15± 11.37
Week 23
GroupValue95% CI
Chemo+Vaccine82.19± 28
Week 46
GroupValue95% CI
Chemotherapy Only77.13± 32.39
Chemo+Vaccine86.84± 10.25
Week 70
GroupValue95% CI
Chemo+Vaccine90.31± 4.95
Frequencies of NK Cells - NKG2D Secondary · Weeks 1, 7, 10, 15, 18, 23, 46, and 70

Using flow cytometry, the frequencies of NK cells were determined for samples collected from multiple timepoints from Week 1 to Week 70. Values were averaged for the percent of NKG2D+NK cells.

Week 1
GroupValue95% CI
Chemotherapy Only90.88± 6.67
Chemo+Vaccine93.74± 4.13
Week 7
GroupValue95% CI
Chemotherapy Only81.76± 6.54
Chemo+Vaccine89.26± 6.24
Week 10
GroupValue95% CI
Chemo+Vaccine78.34± 15.83
Week 15
GroupValue95% CI
Chemo+Vaccine91.66± 6.93
Week 18
GroupValue95% CI
Chemo+Vaccine91.04± 4.94
Week 23
GroupValue95% CI
Chemo+Vaccine91.91± 6.48
Week 46
GroupValue95% CI
Chemotherapy Only86.93± 8.56
Chemo+Vaccine89.33± 5.97
Week 70
GroupValue95% CI
Chemo+Vaccine91.46± 5.32
Frequencies of T Cells - CD3+/CD4+ Secondary · Weeks 1, 7, 10, 15, 18, 23, and 46

Using flow cytometry, the frequencies of CD3+/CD4+ T cells were determined for samples collected from multiple timepoints from Week 1 to Week 46. Values were averaged for the percent of CD4 T cells.

Week 1
GroupValue95% CI
Chemotherapy Only58.9± 16.38
Chemo+Vaccine54.64± 11.64
Week 7
GroupValue95% CI
Chemotherapy Only45.92± 18.34
Chemo+Vaccine59.89± 10.91
Week 10
GroupValue95% CI
Chemo+Vaccine46.59± 12.37
Week 15
GroupValue95% CI
Chemo+Vaccine47.38± 11.60
Week 18
GroupValue95% CI
Chemo+Vaccine48.57± 10.19
Week 23
GroupValue95% CI
Chemo+Vaccine43.97± 14.07
Week 46
GroupValue95% CI
Chemotherapy Only39.83± 5.1
Chemo+Vaccine43.66± 13.72

Adverse events — posted to ClinicalTrials.gov

Time frame: Week 1 to Week 70. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Arm
Serious: 1/5 (20%)
Deaths: 0/5
Chemo+Vaccine Arm
Serious: 4/11 (36%)
Deaths: 1/11

Serious adverse events (13 terms)

ReactionSystemControl ArmChemo+Vaccine Arm
SepsisInfections and infestations——
Atrial FibrilationCardiac disorders——
Thromboembolic eventVascular disorders——
Vascular Disorders - Other, specifyVascular disorders——
Infection and infestations, other, specifyInfections and infestations——
Urinary Tract InfectionInfections and infestations——
Generalized Muscle WeaknessMusculoskeletal and connective tissue disorders——
EncephalopathyNervous system disorders——
ConfusionPsychiatric disorders——
HypoxiaRespiratory, thoracic and mediastinal disorders——
FallInjury, poisoning and procedural complications——
Lymphocyte Count DecreasedInvestigations——
SyncopeNervous system disorders——
Other adverse events (156 terms — click to expand)

ReactionSystemControl ArmChemo+Vaccine Arm
AnemiaBlood and lymphatic system disorders——
FatigueGeneral disorders——
Lymphocyte count decreasedInvestigations——
Investigations, OtherInvestigations——
AlopeciaSkin and subcutaneous tissue disorders——
Injection Site ReactionGeneral disorders——
NauseaGastrointestinal disorders——
White Blood Cells DecreasedInvestigations——
DepressionPsychiatric disorders——
InsomniaPsychiatric disorders——
DiarrheaGastrointestinal disorders——
Skin and subcutaneous disorders, otherSkin and subcutaneous tissue disorders——
Peripheral Sensory NeuropathyNervous system disorders——
HyponatremiaMetabolism and nutrition disorders——
Mucositis OralGastrointestinal disorders——
ConstipationGastrointestinal disorders——
HypokalemiaMetabolism and nutrition disorders——
Neutrophil count decreasedInvestigations——
HypocalcemiaMetabolism and nutrition disorders——
Gastroesophageal reflux diseaseGastrointestinal disorders——
AnxietyPsychiatric disorders——
General disorders and administration site conditions - OtherGeneral disorders——
Creatinine increasedInvestigations——
DizzinessNervous system disorders——
HyperglycemiaMetabolism and nutrition disorders——
HeadacheNervous system disorders——
VomitingGastrointestinal disorders——
ArthritisMusculoskeletal and connective tissue disorders——
Breast PainReproductive system and breast disorders——
Gastrointestinal Disorders, OtherGastrointestinal disorders——
Respiratory, thoracic and mediastinal disorders - OtherRespiratory, thoracic and mediastinal disorders——
Aspartate aminotransferase increasedInvestigations——
Alanine aminotransferase increasedInvestigations——
MyalgiaMusculoskeletal and connective tissue disorders——
Edema LimbsGeneral disorders——
Musculoskeletal and connective tissue disorder - OtherMusculoskeletal and connective tissue disorders——
HypertensionVascular disorders——
Alkaline Phosphatase IncreasedInvestigations——
CoughRespiratory, thoracic and mediastinal disorders——
ArthralgiaMusculoskeletal and connective tissue disorders——

Most-reported serious reactions: Sepsis, Atrial Fibrilation, Thromboembolic event, Vascular Disorders - Other, specify, Infection and infestations, other, specify, Urinary Tract Infection, Generalized Muscle Weakness, Encephalopathy.

Data from ClinicalTrials.gov NCT02938442 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III triple negative breast cancer (TNBC). This study will compare the vaccine plus standard neoadjuvant chemotherapy and surgery to standard neoadjuvant chemotherapy and surgery alone.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cancer vaccines as promising immuno-therapeutics: platforms and current progress.
    Liu J, Fu M, Wang M, Wan D, et al · · 2022 · cited 497× · PMID 35303904 · DOI 10.1186/s13045-022-01247-x
  2. Immunotherapeutic interventions of Triple Negative Breast Cancer.
    Li Z, Qiu Y, Lu W, Jiang Y, et al · · 2018 · cited 99× · PMID 29848327 · DOI 10.1186/s12967-018-1514-7
  3. Immunotherapy in triple negative breast cancer: beyond checkpoint inhibitors.
    Abdou Y, Goudarzi A, Yu JX, Upadhaya S, et al · · 2022 · cited 81× · PMID 36351947 · DOI 10.1038/s41523-022-00486-y
  4. Immunotherapy for HER2-positive breast cancer: recent advances and combination therapeutic approaches.
    Ayoub NM, Al-Shami KM, Yaghan RJ. · · 2019 · cited 69× · PMID 30697064 · DOI 10.2147/bctt.s175360
  5. Therapeutic vaccines for breast cancer: Has the time finally come?
    Corti C, Giachetti PPMB, Eggermont AMM, Delaloge S, et al · · 2022 · cited 55× · PMID 34823982 · DOI 10.1016/j.ejca.2021.10.027
  6. Immunotherapy in triple-negative breast cancer: Insights into tumor immune landscape and therapeutic opportunities.
    Ribeiro R, Carvalho MJ, Goncalves J, Moreira JN. · · 2022 · cited 44× · PMID 36060249 · DOI 10.3389/fmolb.2022.903065
  7. Immunotherapy for triple-negative breast cancer: A molecular insight into the microenvironment, treatment, and resistance.
    Bai X, Ni J, Beretov J, Graham P, et al · · 2021 · cited 33× · PMID 39036372 · DOI 10.1016/j.jncc.2021.06.001
  8. Peptide emulsions in incomplete Freund's adjuvant create effective nurseries promoting egress of systemic CD4<sup>+</sup> and CD8<sup>+</sup> T cells for immunotherapy of cancer.
    Melssen MM, Fisher CT, Slingluff CL, Melief CJM. · · 2022 · cited 30× · PMID 36939214 · DOI 10.1136/jitc-2022-004709

Verify or expand the search:

Other recruiting trials for Triple Negative Breast Cancer

Currently open trials in the same condition.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing