Triple Negative Breast CancerPhase 1/2NCT02938442

Vaccination of Triple Negative Breast Cancer Patients

A Phase 1/2 study testing P10s-PADRE with MONTANIDE™ ISA 51 VG, Doxorubicin and Cyclophosphamide in people with Triple Negative Breast Cancer and Breast Neoplasms, run by University of Arkansas at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Triple Negative Breast Cancer, Breast Neoplasms
What is being tested?: P10s-PADRE with MONTANIDE™ ISA 51 VG, Doxorubicin and Cyclophosphamide
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 2 sitesUnited States
Study dates: 25 Jan 2019to 9 Jan 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Females of all races with biopsy-proven clinical stage I, II, or III TNBC (ER-negative, PR-negative and HER2-negative) 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

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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

Who cannot join

ER-positive, PR-positive, 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.

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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 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 (Week 46 visit). Concurrent enrollment in observational studies is allowed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

Official title: A Combined Phase i/II Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG STERILE Combined With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

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.

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) negative, progesterone receptor (PR) negative and HER2-negative (= triple negative - TN) breast cancer. P10s-PADRE will be administered with MONTANIDE™ ISA 51 VG as adjuvant. Human breast cancers that express Tumor Associated Carbohydrate Antigens (TACAs) can be immunogenic, and enhancing the anti-TACA antibodies and immune effector function already present may augment the cytotoxic effects of standard therapies.

A randomized two-arm, open-label, multi-center phase I/II trial is designed with the goal being to evaluate the efficacy of combining vaccination of the P10s-PADRE formulation with neoadjuvant chemotherapy. Patients will be randomly assigned in a 2:1 ratio to standard chemotherapy plus P10s-PADRE or to standard chemotherapy alone. Efficacy will be based on the rate of pathologic Complete Response (pCR) observed among TN breast-cancer patients treated with the combination as compared with the group of patients who receive standard chemotherapy alone.

Conditions: Triple Negative Breast Cancer, Breast Neoplasms
Being tested: P10s-PADRE with MONTANIDE™ ISA 51 VG, Doxorubicin, Cyclophosphamide, Paclitaxel
Keywords: clinical stage I, II or III, TNBC, ER positive, PR positive, HER2 positive
Medical subject headings: Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

P10s-PADRE with MONTANIDE™ ISA 51 VGBiological
Also called P10s-PADRE/ MONTANIDE™ ISA 51 VG
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
DoxorubicinDrug
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
CyclophosphamideDrug
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
PaclitaxelDrug
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.

Study groups in NCT02938442
Study group	Role	What they receive
Chemotherapy Only Arm	Active comparator	Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks. Receives: Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel
Chemo+Vaccine Arm	Experimental	Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks. Receives: Biological: P10s-PADRE with MONTANIDE™ ISA 51 VG; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability Adverse Events
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
Measured: From the start of treatment to the time of definitive surgery (4-8 weeks after chemo); from Week 0 to Week 20-23
Pathologic Complete Response (pCR)
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.
Measured: During and/or Immediately After Surgery
Pathological Tumor Size
Tumor size at surgery/pathology report
Measured: Surgery
Pathological Node Status: Number of Positive Lymph Nodes
Number of positive lymph nodes found out of dissected lymph nodes
Measured: Surgery
Pathological Node Status: Number of Dissected Lymph Nodes
Number of dissected lymph nodes at surgery for study participants
Measured: Surgery
Tumor Response
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 synonymous with pCR in the published literature.
Measured: Surgery

Secondary outcomes (14)

Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers
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.
Measured: Weeks 7, 10, 15, 18, 23, 46, and 70
Frequencies of NK Cells - CD16
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.
Measured: Week 1, 7, 10, 15, 18, 23, 46, 70
Frequencies of NK Cells - CD69
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.
Measured: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Frequencies of NK Cells - NKp46
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.
Measured: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Frequencies of NK Cells - NKG2D
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.
Measured: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Frequencies of T Cells - CD3+/CD4+
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.
Measured: Weeks 1, 7, 10, 15, 18, 23, and 46
Frequencies of T Cells - CD3+/CD8+
Using flow cytometry, the frequencies of CD3+/CD8+ T cells were determined for samples collected from multiple timepoints from Week 1 to Week 46. Values were averaged for the percent of CD8 T cells.
Measured: Weeks 1, 7, 10, 15, 18, 23, and 46
Frequencies of Cells - CD69+/CD3+
Using flow cytometry, the frequencies of CD69+/CD3+ cells were determined for samples collected from multiple timepoints from Week 1 to Week 70. Values were averaged for the percent of CD69 T cells.
Measured: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Frequencies of Circulating Regulatory T Cells (Tregs)
Peripheral blood mononuclear cells (PBMCs) were isolated from samples collected from multiple timepoints from Week 1 to Week 46. Using flow cytometry, the frequencies of Tregs (CD4, CD25 and CD127) were analyzed for separately, and then summed. The units are reported in CD4+CD25+CD127 low/- percentage because CD127 is a recently discovered antigen associated with Tregs that is weakly expressed on Tregs, while the self-activated memory T cell CD127 is strongly expressed; therefore, CD4+CD25+CD127 low/- is used to represent Tregs now.
Measured: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Activation Profiles of NK Cells: CD16
The expression levels of activation markers on NK cells profile, specifically CD16, were determined for samples collected from multiple timepoints from Week 1 to Week 70. Data is reported in the units Median Fluorescence Intensity (MFI).
Measured: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Activation Profiles of NK Cells: CD69
The expression levels of activation markers on NK cells profile, specifically CD69, were determined for samples collected from multiple timepoints from Week 1 to Week 70. Data is reported in the units Median Fluorescence Intensity (MFI).
Measured: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Activation Profiles of NK Cells: NKp46
The expression levels of activation markers on NK cells profile, specifically NKp46, were determined for samples collected from multiple timepoints from Week 1 to Week 70. Data is reported in the units Median Fluorescence Intensity (MFI).
Measured: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Activation Profiles of NK Cells: NKG2D
The expression levels of activation markers on NK cells profile, specifically NKG2D, were determined for samples collected from multiple timepoints from Week 1 to Week 70. Data is reported in the units Median Fluorescence Intensity (MFI).
Measured: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Activation Profiles of T Cells - CD69 on CD3+
The expression levels of activation markers CD69 on T cells were determined by flow cytometry for samples collected from multiple timepoints from Week 1 to Week 70. Data is reported in the units Median Fluorescence Intensity (MFI).
Measured: Weeks 1, 7, 10, 15, 18, 23, 46, 70

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 20199 Jan 2023

First posted19 Oct 2016 (estimated)
Study start25 Jan 2019
Primary completion9 Jan 2023
Study completion9 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
More trials run by University of ArkansasThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02938442
Sponsor's protocol ID: 206010
Status last verified: Jun 2024
First submitted: 17 Oct 2016
Last updated: 7 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Combined Phase i/II Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG STERILE Combined With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
ClinicalTrials.gov ID: NCT02938442
Acronym / sponsor ID: 206010
Conditions: Triple Negative Breast Cancer, Breast Neoplasms
Keywords: clinical stage I, II or III, TNBC, ER positive, PR positive, HER2 positive
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: University of ArkansasUniversity, hospital or other
Study start: 25 Jan 2019 (actual)
Primary completion: 9 Jan 2023 (actual)
Study completion: 9 Jan 2023 (actual)
First posted: 19 Oct 2016 (estimated)
Results: Posted 5 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Chemotherapy Only Arm	Active comparator	Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: PaclitaxelSubjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Chemo+Vaccine Arm	Experimental	Biological: P10s-PADRE with MONTANIDE™ ISA 51 VG, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: PaclitaxelSubjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Females of all races with biopsy-proven clinical stage I, II, or III TNBC (ER-negative, PR-negative and HER2-negative) 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

Key exclusion criteria (10 listed)

ER-positive, PR-positive, 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
P10s-PADRE with MONTANIDE™ ISA 51 VGAlso: P10s-PADRE/ MONTANIDE™ ISA 51 VGSubjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.	Biological	Chemo+Vaccine Arm
DoxorubicinSubjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.	Drug	Chemo+Vaccine Arm, Chemotherapy Only Arm
CyclophosphamideSubjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.	Drug	Chemo+Vaccine Arm, Chemotherapy Only Arm
PaclitaxelSubjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.	Drug	Chemo+Vaccine Arm, Chemotherapy Only Arm

Primary outcome

Safety and Tolerability Adverse Events
Time frame: 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
Pathologic Complete Response (pCR)
Time frame: 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.
Pathological Tumor Size
Time frame: Surgery
Tumor size at surgery/pathology report
Pathological Node Status: Number of Positive Lymph Nodes
Time frame: Surgery
Number of positive lymph nodes found out of dissected lymph nodes
Pathological Node Status: Number of Dissected Lymph Nodes
Time frame: Surgery
Number of dissected lymph nodes at surgery for study participants
Tumor Response
Time frame: 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 synonymous with pCR in the published literature.

14 secondary outcomes

Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers
Time frame: Weeks 7, 10, 15, 18, 23, 46, and 70
Frequencies of NK Cells - CD16
Time frame: Week 1, 7, 10, 15, 18, 23, 46, 70
Frequencies of NK Cells - CD69
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Frequencies of NK Cells - NKp46
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Frequencies of NK Cells - NKG2D
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Frequencies of T Cells - CD3+/CD4+
Time frame: Weeks 1, 7, 10, 15, 18, 23, and 46
Frequencies of T Cells - CD3+/CD8+
Time frame: Weeks 1, 7, 10, 15, 18, 23, and 46
Frequencies of Cells - CD69+/CD3+
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Frequencies of Circulating Regulatory T Cells (Tregs)
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Activation Profiles of NK Cells: CD16
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Activation Profiles of NK Cells: CD69
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Activation Profiles of NK Cells: NKp46
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Activation Profiles of NK Cells: NKG2D
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Activation Profiles of T Cells - CD69 on CD3+
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, 70

Results and safety

Results posted to the registry on 5 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chemotherapy Only	5	3
Chemo+Vaccine	11	8

Primary outcome: Safety and Tolerability Adverse Events

Time frame: From the start of treatment to the time of definitive surgery (4-8 weeks after chemo); from Week 0 to Week 20-23. Number. Unit: Total events

Measure	Chemotherapy Only n = 5	Chemo+Vaccine n = 11
Value	8	81

Primary outcome: Pathologic Complete Response (pCR)

Time frame: During and/or Immediately After Surgery. Count of participants. Unit: Participants

Measure	Chemotherapy Only n = 5	Chemo+Vaccine n = 11
Pathologic Complete Response (pCR)	1	2
No Pathologic Complete Response (pCR)	4	9

Primary outcome: Pathological Tumor Size

Time frame: Surgery. Mean (Standard Deviation). Unit: centimeters

Measure	Chemotherapy Only n = 5	Chemo+Vaccine n = 9
Value	3.52 (5.65)	0.98 (0.85)

Population analysed: For 2 participants, there was no data.

Primary outcome: Pathological Node Status: Number of Positive Lymph Nodes

Time frame: Surgery. Mean (Standard Deviation). Unit: lymph node

Measure	Chemotherapy Only n = 5	Chemo+Vaccine n = 8
Value	6.6 (14.76)	1.5 (3.46)

Population analysed: For 3 participants, there were no data.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 1 to Week 70. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Arm	1 of 5 (20%)	5 of 5 (100%)	0 of 5
Chemo+Vaccine Arm	4 of 11 (36.4%)	11 of 11 (100%)	1 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sindhu Malapati, MD principal investigator

University of Arkansas

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability Adverse Events (time frame: From the start of treatment to the time of definitive surgery (4-8 weeks after chemo); from Week 0 to Week 20-23). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02938442.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.