CompletedNCT02229084Updated Oct 6, 2026Results posted

Vaccination of High Risk Breast Cancer Patients - A Combined Phase I/II Feasibility-and-Efficacy Study

A Phase 1/2 interventional study of P10s-PADRE/ MONTANIDE™ ISA 51 VG and Doxorubicin in Breast Cancer and Breast Neoplasms, sponsored by University of Arkansas. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by University of Arkansas · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 58
Allocation: Non-randomized
Ages: 18 Years and older
Sex: Female

Study summary

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 estrogen-receptor (ER)-positive, HER2-negative breast cancer.

Read the detailed description

The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients with clinical stage I, II or III estrogen-receptor (ER)-positive, HER2-negative breast cancer.

This is a single-arm, multi-site Phase I/II study designed with the two goals being (1) to evaluate the feasibility of combining vaccination with the P10s-PADRE formulation with neoadjuvant chemotherapy and (2) to determine if the polymerase chain reaction (pCR) rate among ER-positive, HER2-negativebreast-cancer patients treated with the combination is significantly higher than the 8% rate observed among ER-positive breast-cancer subjects in a pooled analysis of seven randomized clinical trials. P10s-PADRE vaccine with MONTANIDE™ ISA 51 VG as adjuvant will be given in combination with neoadjuvant chemotherapy in female patients with clinical stage I, II or III ER-positive, HER2-negative breast cancer.

This combined Phase I/II feasibility-and-efficacy study will have three parts. Its first part will be a Phase I evaluation of the safety, tolerability, and feasibility of eliciting adequate IgG response with P10s-PADRE when administered in combination with SoC neoadjuvant chemotherapy. The study's second and third parts will respectively constitute Stages 1 and 2 of the Phase II primary-efficacy evaluation of Chemovax using a Simon optimal two-stage design

To evaluate the feasibility of eliciting adequate immune response with P10s-PADRE when it is administered in combination with neoadjuvant chemotherapy, we will sequentially evaluate different schedules of vaccination relative to chemotherapy, and stop evaluating as soon as we have identified a feasible schedule. To this end, we have defined five different Chemovax schedules, and named them A, B, C, D, and E;

Conditions studied

Breast Cancer
Breast Neoplasms

Browse trials for

Breast Neoplasms 12,544

Keywords

clinical stage I, II or III
ER postive
HER2 negative

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 58 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

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

Who can participate

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

Inclusion criteria

Females of all races with clinical stage I, II, or III ER-positive, HER2 negative breast cancer who will undergo SoC neoadjuvant treatment.
Age 18 years and older.
ECOG Performance Status 0 or 1.
White blood cell (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration.
Platelet count ≥ 100,000/mm3 within 3 weeks prior to registration.
Bilirubin ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration.
Serum glutamic-oxaloacetic transaminase (SGOT) or aspartate aminotransferase test (AST) ≤ 2 x IUL of normal obtained within 3 weeks prior to registration.
Serum glutamic-pyruvic transaminase (SGPT) or alanine aminotransferase test (ALT) ≤ 2 x IUL of normal obtained within 3 weeks prior to registration.
Serum creatinine ≤ 1.8 mg/dL obtained within 3 weeks prior to registration.
Must sign an informed consent document approved by the UAMS IRB.

Exclusion criteria

Exclusion Criteria:

ER-negative, HER2-positive, inflammatory, metastatic, stage IV or recurrent breast cancer
Active infection requiring treatment with antibiotics.
Existing diagnosis or history of organic brain syndrome that might preclude participation in the full protocol.
Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol.
Other current malignancies. Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
Active autoimmune disorders or conditions of immunosuppression; Existing diagnosis or history of autoimmune disorders or conditions of immunosuppression that have been in remission for less than 6 months
Treatment with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when used as an antiemetic in SoC therapy]), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. Subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. Replacement doses of steroids for subjects with adrenal insufficiency are allowed.
Pregnancy or breastfeeding (due to the unknown effects of peptide/mimotope vaccines on a fetus or infant). Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to starting week 1 and must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. Accepted methods of contraception include tubal ligation, oral contraceptives, barrier methods, IUDs, and abstinence.
Any other significant medical or psychiatric conditions, which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen.
Enrollment in any other clinical trial using investigational drug products or devices prior to first post-surgery study lab. Concurrent enrollment in observational studies is allowed.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 58 participants (actual)

Study arms

Experimental
Part 1 - Chemovax Schedule A
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Docetaxel
Experimental
Part 1 - Chemovax Schedule B
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Docetaxel
Experimental
Part 1 - Chemovax Schedule C
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Docetaxel
Experimental
Part 1 - Chemovax Schedule D
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Docetaxel
Experimental
Part 1 - Chemovax Schedule E
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Docetaxel
Experimental
Part 2 - Chemovax Schedule C
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Docetaxel
Experimental
Part 3 - Chemovax Schedule C
Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Docetaxel

Interventions

BiologicalP10s-PADRE/ MONTANIDE™ ISA 51 VG
Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions concurrent with chemotherapy.
DrugDoxorubicin
Doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg/m2) every three weeks for four cycles.
DrugCyclophosphamide
Doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg/m2) every three weeks for four cycles.
DrugDocetaxel
Doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg/m2) every three weeks for four cycles. If docetaxel is not tolerated, paclitaxel (175mg/m2) may be used in its place.

What researchers measure

Primary outcomes

Identify a Feasible Schedule of Vaccination Relative to SoC Neoadjuvant Chemotherapy When the Chemovax Are Administered Concurrently.
Number of participants with sufficiently high anti-P10s immunoglobulin-G response Feasibility will be evaluated in terms of 1. Generation of a sufficiently high anti-P10s immunoglobulin-G response 2. Safety and tolerability of the combination of vaccine and chemotherapy
Time frame: At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)
Determine the pCR Rate
The patient-level primary outcome for this objective is pathological Complete Response (pCR), which is binary yes/no, and the study-level endpoint for this outcome is the rate of pCR, i.e. the percentage of patients that achieved pCR=yes. The patient is assessed at the time of surgery for whether they achieved pCR=yes. They have to do the surgery in order to obtain the tissue samples on which they do their pCR assessment. Pathological Complete Response is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0N0 or ypTisN0 in the AJCC staging system for staging solid tumors in the neoadjuvant setting that was described in a 2014 FDA Guidance for Industry).
Time frame: At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)

Secondary outcomes

P10s-MAP-Reactive Immunoglobulin Titers
The anti-P10s binding level was measured via ELISA method after incubation with a subject's serum or plasma sample. Data was collected at multiple timepoints throughout the study. Values were averaged for each group.
Time frame: Week 1 through Week 70
Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD16
Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample. Data was collected at multiple timepoints throughout the study. Values were averaged for each group. For some participants, CD16 was not assessable.
Time frame: Week 1 through Week 70
Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD69
Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample. Data was collected at multiple timepoints throughout the study. Values were averaged for each group. For some participants, CD69 was not assessable.
Time frame: Week 1 through Week 70
Activation Profiles of NK Cells: Pre-Immune and Post-Immune NKp46
Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample. Data was collected at multiple timepoints throughout the study. Values were averaged for each group. For some participants, NKp46 was not assessable.
Time frame: Week 1 through Week 70

Results

Posted May 23, 2024

Participant flow

Potential subjects were recruited from the Winthrop P Rockefeller Cancer Institute on the University of Arkansas for Medical Sciences campus and clinics at Highlands Oncology Group.

Participant flow — Overall Study
Milestone	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C
Started	5	5	5	5	5	19	14
Completed	4	5	3	3	1	18	10
Not completed	1	0	2	2	4	1	4
Withdrew: Adverse event	1	0	0	0	0	0	0
Withdrew: Lost to follow-up	0	0	1	1	0	0	1
Withdrew: Physician decision	0	0	0	1	3	0	1
Withdrew: Withdrawal by subject	0	0	1	0	1	1	1
Withdrew: Death	0	0	0	0	0	0	1

Outcome measures

PrimaryIdentify a Feasible Schedule of Vaccination Relative to SoC Neoadjuvant Chemotherapy When the Chemovax Are Administered Concurrently.

Number of participants with sufficiently high anti-P10s immunoglobulin-G response Feasibility will be evaluated in terms of 1. Generation of a sufficiently high anti-P10s immunoglobulin-G response 2. Safety and tolerability of the combination of vaccine and chemotherapy

Time frame:: At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)
Reported as:: Count of participants · Participants

Identify a Feasible Schedule of Vaccination Relative to SoC Neoadjuvant Chemotherapy When the Chemovax Are Administered Concurrently.
Participants	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E
Greater than or equal to 4-fold increase	3	2	4	2	4
Less than 4-fold increase	2	3	1	3	1

PrimaryDetermine the pCR Rate

The patient-level primary outcome for this objective is pathological Complete Response (pCR), which is binary yes/no, and the study-level endpoint for this outcome is the rate of pCR, i.e. the percentage of patients that achieved pCR=yes. The patient is assessed at the time of surgery for whether they achieved pCR=yes. They have to do the surgery in order to obtain the tissue samples on which they do their pCR assessment. Pathological Complete Response is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0N0 or ypTisN0 in the AJCC staging system for staging solid tumors in the neoadjuvant setting that was described in a 2014 FDA Guidance for Industry).

Time frame:: At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)
Reported as:: Count of participants · Participants

Determine the pCR Rate
Participants	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C
Determine the pCR Rate	0	0	0	0	0	3	1

SecondaryP10s-MAP-Reactive Immunoglobulin Titers

The anti-P10s binding level was measured via ELISA method after incubation with a subject's serum or plasma sample. Data was collected at multiple timepoints throughout the study. Values were averaged for each group.

Time frame:: Week 1 through Week 70
Reported as:: Mean · titers

P10s-MAP-Reactive Immunoglobulin Titers
titers	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E
P10s-MAP-Reactive Immunoglobulin Titers	10.72 ± 14.97	9.76 ± 13.91	42.25 ± 71.94	4.38 ± 5.10	6.74 ± 7

SecondaryActivation Profiles of NK Cells: Pre-Immune and Post-Immune CD16

Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample. Data was collected at multiple timepoints throughout the study. Values were averaged for each group. For some participants, CD16 was not assessable.

Time frame:: Week 1 through Week 70
Reported as:: Mean · Median Fluorescence Intensity (MFI)

Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD16
Median Fluorescence Intensity (MFI)	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C
Pre-Immune CD16	26065 ± 7976.46	26580 ± 2261.51	25171.8 ± 6493	28546 ± 7197.16	24897 ± 5334.72	67445.83 ± 31389.28	68619.59 ± 27944.66
Post-Immune CD16	19745.4 ± 5182.72	20993.4 ± 7061.48	27998.6 ± 10142.41	22959.8 ± 6020.06	25711.75 ± 20572.69	62323.05 ± 24021.75	65410.12 ± 24645.52

SecondaryActivation Profiles of NK Cells: Pre-Immune and Post-Immune CD69

Time frame:: Week 1 through Week 70
Reported as:: Mean · Median Fluorescence Intensity (MFI)

Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD69
Median Fluorescence Intensity (MFI)	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C
Pre-Immune CD69	268.2 ± 50.08	300.8 ± 88.02	291.4 ± 38.55	294.6 ± 57.27	296.25 ± 34.37	428 ± 133	445.5 ± 169.17
Post-Immune CD69	307 ± 72.29	329.6 ± 26.23	275 ± 25.25	278.4 ± 27.87	311.25 ± 16.76	489.44 ± 139.9	505.97 ± 161.11

SecondaryActivation Profiles of NK Cells: Pre-Immune and Post-Immune NKp46

Time frame:: Week 1 through Week 70
Reported as:: Mean · Median Fluorescence Intensity (MFI)

Activation Profiles of NK Cells: Pre-Immune and Post-Immune NKp46
Median Fluorescence Intensity (MFI)	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C
Pre-Immune NKp46	685.2 ± 390.469	590.4 ± 204.147	724.2 ± 422.436	794.2 ± 355.618	744.25 ± 251.998	1360.33 ± 638.97	1650.08 ± 878.64
Post-Immune NKp46	1391 ± 489.819	1115.6 ± 485.348	1084.2 ± 930.867	1168.2 ± 324.282	1505.5 ± 1031.69	1412.13 ± 645.68	1813.56 ± 879.38

Adverse events

Collected over Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1 - Chemovax Schedule A	0/5 (0%)	4/5 (80%)	5/5 (100%)
Part 1 - Chemovax Schedule B	0/5 (0%)	4/5 (80%)	5/5 (100%)
Part 1 - Chemovax Schedule C	0/5 (0%)	3/5 (60%)	5/5 (100%)
Part 1 - Chemovax Schedule D	0/5 (0%)	1/5 (20%)	5/5 (100%)
Part 1 - Chemovax Schedule E	0/5 (0%)	3/5 (60%)	5/5 (100%)
Part 2 & 3 Combined - Chemovax Schedule C	1/33 (3%)	19/33 (57.6%)	33/33 (100%)

Most frequent serious events

Showing 10 of 72

Most frequent serious events
Event	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 & 3 Combined - Chemovax Schedule C
AnemiaBlood and lymphatic system disorders	0/5	1/5	2/5	0/5	0/5	6/33
Febrile NeutropeniaBlood and lymphatic system disorders	0/5	2/5	0/5	0/5	2/5	1/33
Mucositis OralGastrointestinal disorders	2/5	0/5	1/5	0/5	0/5	2/33
Lymphocyte count decreasedInvestigations	0/5	2/5	1/5	1/5	0/5	5/33
HypertensionVascular disorders	0/5	2/5	0/5	0/5	0/5	0/33
Abdominal distensionGastrointestinal disorders	1/5	0/5	0/5	0/5	0/5	0/33
VertigoEar and labyrinth disorders	0/5	1/5	0/5	0/5	0/5	0/33
EsophagitisGastrointestinal disorders	0/5	0/5	1/5	0/5	0/5	1/33
NauseaGastrointestinal disorders	1/5	0/5	0/5	0/5	0/5	2/33
VomittingGastrointestinal disorders	1/5	1/5	0/5	0/5	0/5	2/33

Most frequent other events

Showing 10 of 226

Most frequent other events
Event	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 & 3 Combined - Chemovax Schedule C
AnemiaBlood and lymphatic system disorders	1/5	5/5	5/5	3/5	1/5	29/33
NauseaGastrointestinal disorders	3/5	4/5	4/5	5/5	4/5	29/33
FatigueGeneral disorders	3/5	3/5	4/5	4/5	5/5	30/33
Injection site reactionGeneral disorders	4/5	5/5	5/5	5/5	5/5	30/33
Lymphocyte count decreasedInvestigations	2/5	5/5	4/5	1/5	0/5	26/33
Neutrophil count decreasedInvestigations	0/5	0/5	3/5	5/5	3/5	18/33
ConstipationGastrointestinal disorders	2/5	2/5	1/5	4/5	2/5	22/33
Edema limbsGeneral disorders	4/5	2/5	0/5	2/5	1/5	9/33
Investigations - Other, specifyInvestigations	0/5	4/5	4/5	0/5	0/5	0/33
MyalgiaMusculoskeletal and connective tissue disorders	0/5	1/5	1/5	4/5	1/5	14/33

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C	Total
<=18 years	0	0	0	0	0	0	0	0
Between 18 and 65 years	4	4	4	3	4	17	13	49
>=65 years	1	1	1	2	1	2	1	9

Age, Continuous
Age, Continuous(years)	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C	Total
Mean	59 ± 12.37	53 ± 10.2	57.6 ± 11.69	54.8 ± 15.42	43.4 ± 15.24	52.58 ± 10.73	46.86 ± 10.73	50.15 ± 10.94

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C	Total
Female	5	5	5	5	5	19	14	58
Male	0	0	0	0	0	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C	Total
Hispanic or Latino	0	0	0	0	0	0	2	2
Not Hispanic or Latino	0	0	0	0	0	10	6	16
Unknown or Not Reported	5	5	5	5	5	9	6	40

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0
Asian	0	1	0	0	0	0	1	2
Native Hawaiian or Pacific Islander	0	0	0	0	0	0	0	0
Black or African American	0	1	0	0	0	5	3	9
White	5	3	5	5	5	14	8	45
Other	0	0	0	0	0	0	2	2
More than one race	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C	Total
United States — Central Arkansas at University of Arkansas for Medical Sciences	5	5	2	1	0	10	14	37
United States — Northwest Arkansas at Highlands Oncology Group	0	0	3	4	5	9	0	21

Eastern Cooperative Oncology Group (ECOG) Performance Status
Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants)	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C	Total
0 Fully active, able to carry on all pre-disease	4	5	5	4	4	18	13	53
1 Restricted in physically strenuous activity but ambulatory and able to carry out work	1	0	0	1	1	1	1	5

Pre-Treatment Tumor Size
Pre-Treatment Tumor Size(centimeters)	Part 1 - Chemovax Schedule A	Part 1 - Chemovax Schedule B	Part 1 - Chemovax Schedule C	Part 1 - Chemovax Schedule D	Part 1 - Chemovax Schedule E	Part 2 - Chemovax Schedule C	Part 3 - Chemovax Schedule C	Total
Mean	2.9 ± .84	4.06 ± 1.44	4.82 ± 2.03	3.76 ± 2.56	1.96 ± 0.82	4.13 ± 2.67	5.43 ± 2.19	4.03 ± 2.38

3 further baseline measures are reported on the registry.

Study locations

2 sites

Highlands Oncology Group
Fayetteville, Arkansas 72703, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205, United States

References and documents

Publications

Hernandez Puente CV, Hsu PC, Rogers LJ, Jousheghany F, Siegel E, Kadlubar SA, Beck JT, Makhoul I, Hutchins LF, Kieber-Emmons T, Monzavi-Karbassi B. Association of DNA-Methylation Profiles With Immune Responses Elicited in Breast Cancer Patients Immunized With a Carbohydrate-Mimicking Peptide: A Pilot Study. Front Oncol. 2020 Jun 5;10:879. doi: 10.3389/fonc.2020.00879. eCollection 2020. PubMed 32582547 ↗

Study documents

Protocol and statistical analysis plan · Jun 2, 2022
Informed consent form · Oct 6, 2021

Documents are hosted by the registry — open the source record to download them.

Updates

1 registry update since Sep 25, 2026

Minor edits

Nothing that changes what the study is or who can join. Edited: index terms, identifiers and verification date

1 update, last Oct 6, 2026

Show all 1 update

Oct 6, 2026
Minor edits only
+ 3 other changes: index terms, identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02229084
Lead sponsor: University of Arkansas
Responsible party: Sponsor
First posted: Aug 29, 2014
Start date: Jan 14, 2015
Primary completion: Jan 3, 2023
Completion: Jan 3, 2023
Results posted: May 23, 2024
Last update: Oct 6, 2026

Study contacts

Sri Obulareddy, MD

principal investigator · University of Arkansas

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 completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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