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Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients (HER3+)

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

NeuVax vaccine

Trastuzumab

GM-CSF

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer, NeuVax

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

18 years or older
Eastern Cooperative Oncology Group (ECOG) performance status 0,1
AJCC stage I - III non-inflammatory, HER2-positive (according to ASCO-CAP guidelines 5) breast cancer
Completed neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy and underwent surgery with final pathology showing evidence of residual disease in the breast or axilla (residual ductal carcinoma in situ or microinvasive disease not eligible) or underwent surgery as a first intervention and was found to be pathologically node-positive: ≥ 4 positive lymph nodes (pN2 or pN3) regardless of hormone receptor status or 1-3 positive lymph nodes (pN1) if hormone receptor negative. Patients with micrometastases (pN1mi) are not eligible.
Completed an approved regimen of neoadjuvant or adjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy with plan for completion of one year of trastuzumab therapy.
Completed appropriate surgical therapy to include:
1. Total mastectomy and axillary staging with sentinel lymph node dissection or axillary lymph node dissection (level I/II). Patients with a positive sentinel lymph node must have undergone a completion axillary lymph node dissection.
2. Breast conserving surgery (BCS) and axillary staging with sentinel lymph node dissection or axillary lymph node dissection. Patients undergoing surgery as a first intervention with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes. Patients receiving neoadjuvant chemotherapy that have a positive sentinel lymph node must have undergone a completion axillary lymph node dissection.
3. Completed or receiving appropriate radiation therapy if indicated:

For patients undergoing total mastectomy surgery as a first intervention, post-mastectomy radiation to the chest wall, infraclavicular and supraclavicular areas is required for patients with ≥ 4 positive lymph nodes. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 1-3 positive lymph nodes, post-mastectomy radiation to the chest wall, infraclavicular, supraclavicular, and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist.

For patients undergoing breast conserving surgery (BCS) as a first intervention, whole breast irradiation with or without a boost, and radiation to the infraclavicular and supraclavicular areas is required for patients with ≥ 4 positive lymph nodes. Radiation to the internal mammary lymph nodes is not required but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 1-3 positive lymph nodes, whole breast irradiation with or without a boost is required. Radiation to the infraclavicular, supraclavicular, and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating medical oncologist.
For patient's undergoing mastectomy after neoadjuvant chemotherapy post-mastectomy radiation to the chest wall, infraclavicular and supraclavicular areas is required for patients presenting with clinical N2 or N3 disease or with ≥ 4 positive lymph nodes identified pathologically at the time of surgery. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 0-3 positive lymph nodes identified pathologically, post-mastectomy radiation to the chest wall, infraclavicular, supraclavicular and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist.
For patient's undergoing BCS after neoadjuvant chemotherapy, whole breast irradiation with or without a boost is required. For patients with clinical N2 or N3 disease or with ≥ 4 positive lymph nodes identified pathologically at the time of surgery, radiation to the infraclavicular and supraclavicular areas is required. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 0-3 positive lymph nodes identified pathologically, radiation to the infraclavicular, supraclavicular and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist.
- HLA-A2+ or HLA-A3+ or HLA-A24+ or HLA-A26+
- LVEF >50%, or an LVEF within the normal limits of the institution's specific testing (MUGA or ECHO)
- Adequate organ function as determined by the following laboratory values:
  1. ANC ≥ 1,000/μL
  2. Platelets ≥ 75,000/μL
  3. Hgb ≥ 9 g/dL
  4. Creatinine ≤ 1.5 x upper limit of normal (ULN) of institution's range or Creatinine clearance ≥ 50%
  5. Total bilirubin ≤ 1.5 ULN of institution's range
  6. ALT and AST ≤ 1.5 ULN of institution's range
  7. For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
- Signed informed consent

Exclusion criteria:

AJCC Stage IV breast cancer
NYHA stage 3 or 4 congestive heart failure
Immune deficiency disease or known history of HIV, HBV, HCV
Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents
Pregnancy (assessed by urine HCG)
Breast feeding
Any active autoimmune disease requiring treatment, with the exception of vitiligo
Active pulmonary disease requiring medication to include multiple inhalers (>3 inhalers including one containing steroids)
Involved in other experimental protocols except with permission of other PI

Sites / Locations

Sarcoma Oncology Research Center, LLC
St Joseph Heritage Healthcare
Sibley Memorial Hospital
University of Miami
Memorial Breast Cancer Center
University of Miami
University of Miami
Florida Cancer Research Institute
University of Miami
Loyola University Medical Center
Memorial Hospital of South Bend
Cancer Center of Kansas
Medstar Health (Union Memorial Hospital)
Medstar (Good Samaritan Hospital)
The Valley Hospital
University of New Mexico Cancer Center
New Mexico Cancer Care Alliance/Presbyterian Cancer Center
North Shore Hematology Oncology Associates
Tisch Cancer Institute/Icahn School of Medicine at Mount Sinai
MD Anderson Cancer Center
Texas Oncology (Cancer Care Centers of South Texas)
University of Virginia Human Immune Therapy Center
Providence Regional Medical Center
Ascension/ Columbia St. Mary's

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trastuzumab + NeuVax

Trastuzumab + GM-CSF

Arm Description

Patients randomized to this arm will receive vaccinations of nelipepimut-S (1000 μg) and GM-CSF (250 μg) (NeuVax vaccine) administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first vaccination will be given with the third dose of maintenance trastuzumab administered as monotherapy optimally, but may be given with later maintenance doses of trastuzumab, provided there are at least six remaining doses of trastuzumbab to overlap with the PVS. Upon completion of the primary vaccination series (PVS), booster inoculations (same dose and route) will be administered every six months x 4. The first booster inoculation will occur 6 months ± 2 weeks after the completion of the PVS, with subsequent boosters timed every six months + 2 weeks. Boosters will therefore occur at the following time points after completion of the PVS: 6 months ± 2 weeks, 12 months ± 2 weeks, 18 months ± 2 weeks and 24 months ± 2 weeks.

Patients randomized to this arm will receive inoculations of GM-CSF (250 μg) administered in an identical manner to those receiving nelipepimut-S/GM-CSF (NeuVax). Patients will be blinded as to whether they are receiving nelipepimut-S/GM-CSF or GM-CSF alone. Upon completion of the primary vaccination series (PVS), booster inoculations (same dose and route) will be administered every six months x 4. The first booster inoculation will occur 6 months ± 2 weeks after the completion of the PVS, with subsequent boosters timed every six months + 2 weeks. Boosters will therefore occur at the following time points after completion of the PVS: 6 months ± 2 weeks, 12 months ± 2 weeks, 18 months ± 2 weeks and 24 months ± 2 weeks.

Outcomes

Primary Outcome Measures

Invasive Disease-free survival (DFS)

Compare invasive DFS between the two treatment groups from time of initiation of trastuzumab maintenance therapy (trasuzumab monotherapy) to time of invasive local, regional or distant recurrence, new primary, or death due to any cause. Disease state will be determined by the patients' own physicians at the individual study sites during their routine follow-up screening. This will occur for all enrolled patients, regardless of randomization, approximately every three months for the first 24 months after completion of primary therapies and every six months thereafter with clinical exam, and laboratory and radiographic surveillance. The primary outcome measure of the trial is invasive DFS.

Secondary Outcome Measures

Distant recurrence-free survival (DRFS)

DRFS will be assessed as part of the patient's disease state as determined by their physician at the individual study sites during routine follow-up screening. Determination of DRFS will allow for continued follow-up on patients with local or regional recurrence.

Local and systemic toxicities

Standard local and systemic toxicities will be collected and graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 graded toxicity scale. For both the inoculations during the primary vaccine/inoculation series and the booster inoculations, patients will be monitored closely for one hour after inoculation with questioning, serial exams and vital signs every 15 minutes to observe for a hypersensitivity reaction. Additionally, patients will return to their study site 48-72 hours after inoculation for questioning regarding any systemic toxicity and local injection site reactions. When they return to their study site, the local reaction at the inoculation sites will be examined and measured.

Evaluate in vivo and in vitro immune responses

Immune responses will be primarily documented using the delayed type hypersensitivity (DTH) reaction and using the dextramer assay to enumerate peptide-specific CTL. Each of these measurements will be performed regardless of randomization. DTH reactions will be measured prior to initiation of the primary vaccine/inoculation series, one month ± 1 week after completion of the primary vaccine/inoculation series, and one month ± 1 week after the final booster inoculation. Dextramer measurements will be performed prior to initiating the primary vaccine/inoculation series as well as one month ± 1 week after completion of the vaccine/inoculation series. Additionally, these assays may be performed pre- and post-each booster. Alternatively, these assayed time points may also be performed all at once on frozen and banked cells.

Full Information

NCT ID

NCT02297698

First Posted

November 14, 2014

Last Updated

September 15, 2022

Sponsor

Cancer Insight, LLC

Collaborators

Genentech, Inc., Sellas Life Sciences Group

1. Study Identification

Unique Protocol Identification Number

NCT02297698

Brief Title

Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients

Acronym

HER3+

Official Title

Phase II Trial of Combination Immunotherapy With Nelipepimut-S + GM-CSF (NeuVax™) and Trastuzumab in High-risk HER2+ Breast Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2021 (Actual)

Study Completion Date

December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cancer Insight, LLC

Collaborators

Genentech, Inc., Sellas Life Sciences Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This will be a multi-center, prospective, randomized, single-blinded, placebo-controlled phase II trial of trastuzumab + nelipepimut-S/GM-CSF versus trastuzumab + GM-CSF alone. Our target study population is high-risk HER2-positive breast cancer patients. High-risk HER2-positive breast cancer patients are defined as: Those with HER2-positive breast cancer, regardless of hormone receptor status, who receive neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy, and fail to achieve a pCR. Those with HER2-positive breast cancer, regardless of hormone receptor status, who undergo surgery as a first intervention and are found to have ≥ 4 positive lymph nodes. Those with HER2-positive, hormone receptor negative breast cancer who undergo surgery as a first intervention and are found to have 1-3 positive lymph nodes. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA-typed.

Detailed Description

In this study, the investigators intend to assess the ability of the combination of trastuzumab and the HER2 vaccine nelipepimut-S (administered with the immunoadjuvant GM-CSF) given in the adjuvant setting to prevent recurrences in patients with high-risk HER2-positive breast cancer. High-risk is defined as those patients that do not achieve a pCR after neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy or those who undergo upfront surgery and are found to have greater than or equal to four positive lymph nodes regardless of hormone receptor status or 1-3 positive lymph nodes and are hormone receptor negative. Following surgery, patients will be screened and HLA-typed (consent #1). Nelipepimut-S is a CD8-eliciting peptide vaccine that is restricted to HLA-2+ or HLA-A3+ or HLA-A24+ or HLA-A26+ patients (approximately 80% of the US population). HLA-A2+/A3+/A24+/orA26+ patients who meet all other eligibility criteria will be randomized to receive trastuzumab + nelipepimut-S/GM-CSF or trastuzumab + GM-CSF alone (consent #2). The trastuzumab will be administered to all patients consistent with current standard of care. Patients randomized to the nelipepimut-S/GM-CSF arm will receive vaccinations of nelipepimut-S (1000 mcg) and GM-CSF (250 mcg) administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first vaccination will be given with the third dose of maintenance trastuzumab administered as monotherapy optimally, but may be given with later maintenance doses of trastuzumab, provided there are at least six remaining doses of trastuzumab to overlap with the primary vaccine series. Patients randomized to the GM-CSF alone arm will receive inoculations of GM-CSF (250 mcg) administered in an identical manner to those receiving nelipepimut-S/GM-CSF. Patients will be blinded as to whether they are receiving nelipepimut-S/GM-CSF or GM-CSF alone. Upon completion of the primary vaccination/inoculation series, booster inoculations (same dose and route) will be administered every six months x 4. The first booster inoculation will occur 6 months ± 2 weeks after the completion of the PVS, with subsequent boosters timed every six months + 2 weeks. Boosters will therefore occur at the following time points after completion of the PVS: 6 months ± 2 weeks, 12 months ± 2 weeks, 18 months ± 2 weeks, 24 months ± 2 weeks. Booster inoculations will occur for patients randomized to receive nelipepimut-S/GM-CSF as well as patients randomized to receive GM-CSF alone, and will consist of the same treatment drugs and dosing (i.e., nelipepimut-S/GM-CSF patients will be boosted with nelipepimut-S/GM-CSF while GM-CSF alone patients will be boosted with GM-CSF alone). Patient blinding will be maintained throughout the study. Subjects will be followed for safety issues, immunologic response and clinical recurrence. Patients will be monitored 48-72 hours after each inoculation for reaction to the inoculation as well as documentation of any adverse effects experienced. Immunologic response will be monitored primarily by in vivo delayed type hypersensitivity (DTH) reactions but also may be documented by other immunologic assays. All patients will be followed for a total of 36 months from the time of initiation of trastuzumab maintenance therapy to document disease-free status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast cancer, NeuVax

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trastuzumab + NeuVax

Arm Type

Experimental

Arm Description

Arm Title

Trastuzumab + GM-CSF

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

NeuVax vaccine

Other Intervention Name(s)

nelipepimut-S

Intervention Description

At the time of vaccine administration, a frozen solution of E75 acetate (1.5 mg/mL) is thawed and 1000mcg E75 peptide mixed thoroughly with 250mcg GM-CSF. This constitutes the NeuVax vaccine. Patients randomized to this arm will receive vaccinations of nelipepimut-S/GM-CSF administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first vaccination will be given with the third dose of maintenance trastuzumab administered as monotherapy optimally, but may be given with later maintenance doses of trastuzumab, provided there are at least six remaining doses of trastuzumab to overlap with the primary vaccine series.

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Other Intervention Name(s)

Herceptin

Intervention Description

Herceptin will be administered to patients every three weeks as monotherapy for one year, to be given upon completion of standard of care chemotherapy/radiotherapy. The first trastuzumab infusion will be given no sooner than three weeks and no later than 12 weeks after completion of chemotherapy/radiotherapy. Trastuzumab will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk.

Intervention Type

Drug

Intervention Name(s)

GM-CSF

Other Intervention Name(s)

Leukine, Sargramostim

Intervention Description

For patients randomized to the GM-CSF alone arm, they will receive inoculations of GM-CSF (250mcg) administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first injection will be given with the third dose of maintenance trastuzumab administered as monotherapy optimally, but may be given with later maintenance doses of trastuzumab, provided there are at least six remaining doses of trastuzumab to overlap with the primary vaccine series.

Primary Outcome Measure Information:

Title

Invasive Disease-free survival (DFS)

Description

Time Frame

Initiation of trastuzumab monotherapy through the end of the patient's fifth year of participation in the study.

Secondary Outcome Measure Information:

Title

Distant recurrence-free survival (DRFS)

Description

Time Frame

Initiation of trastuzumab monotherapy through the end of the patient's fifth year of participation in the study.

Title

Local and systemic toxicities

Description

Time Frame

From the date of initiation of the vaccine or inoculation series and booster series up to 36 months.

Title

Evaluate in vivo and in vitro immune responses

Description

Time Frame

From the date of the first inoculation of Trastuzumab monotherapy to the end of the patient's fifth year of participation in the study.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 18 years or older Eastern Cooperative Oncology Group (ECOG) performance status 0,1 AJCC stage I - III non-inflammatory, HER2-positive (according to ASCO-CAP guidelines 5) breast cancer Completed neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy and underwent surgery with final pathology showing evidence of residual disease in the breast or axilla (residual ductal carcinoma in situ or microinvasive disease not eligible) or underwent surgery as a first intervention and was found to be pathologically node-positive: ≥ 4 positive lymph nodes (pN2 or pN3) regardless of hormone receptor status or 1-3 positive lymph nodes (pN1) if hormone receptor negative. Patients with micrometastases (pN1mi) are not eligible. Completed an approved regimen of neoadjuvant or adjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy with plan for completion of one year of trastuzumab therapy. Completed appropriate surgical therapy to include: Total mastectomy and axillary staging with sentinel lymph node dissection or axillary lymph node dissection (level I/II). Patients with a positive sentinel lymph node must have undergone a completion axillary lymph node dissection. Breast conserving surgery (BCS) and axillary staging with sentinel lymph node dissection or axillary lymph node dissection. Patients undergoing surgery as a first intervention with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes. Patients receiving neoadjuvant chemotherapy that have a positive sentinel lymph node must have undergone a completion axillary lymph node dissection. Completed or receiving appropriate radiation therapy if indicated: For patients undergoing total mastectomy surgery as a first intervention, post-mastectomy radiation to the chest wall, infraclavicular and supraclavicular areas is required for patients with ≥ 4 positive lymph nodes. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 1-3 positive lymph nodes, post-mastectomy radiation to the chest wall, infraclavicular, supraclavicular, and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients undergoing breast conserving surgery (BCS) as a first intervention, whole breast irradiation with or without a boost, and radiation to the infraclavicular and supraclavicular areas is required for patients with ≥ 4 positive lymph nodes. Radiation to the internal mammary lymph nodes is not required but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 1-3 positive lymph nodes, whole breast irradiation with or without a boost is required. Radiation to the infraclavicular, supraclavicular, and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating medical oncologist. For patient's undergoing mastectomy after neoadjuvant chemotherapy post-mastectomy radiation to the chest wall, infraclavicular and supraclavicular areas is required for patients presenting with clinical N2 or N3 disease or with ≥ 4 positive lymph nodes identified pathologically at the time of surgery. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 0-3 positive lymph nodes identified pathologically, post-mastectomy radiation to the chest wall, infraclavicular, supraclavicular and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patient's undergoing BCS after neoadjuvant chemotherapy, whole breast irradiation with or without a boost is required. For patients with clinical N2 or N3 disease or with ≥ 4 positive lymph nodes identified pathologically at the time of surgery, radiation to the infraclavicular and supraclavicular areas is required. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 0-3 positive lymph nodes identified pathologically, radiation to the infraclavicular, supraclavicular and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. HLA-A2+ or HLA-A3+ or HLA-A24+ or HLA-A26+ LVEF >50%, or an LVEF within the normal limits of the institution's specific testing (MUGA or ECHO) Adequate organ function as determined by the following laboratory values: ANC ≥ 1,000/μL Platelets ≥ 75,000/μL Hgb ≥ 9 g/dL Creatinine ≤ 1.5 x upper limit of normal (ULN) of institution's range or Creatinine clearance ≥ 50% Total bilirubin ≤ 1.5 ULN of institution's range ALT and AST ≤ 1.5 ULN of institution's range For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms) Signed informed consent Exclusion criteria: AJCC Stage IV breast cancer NYHA stage 3 or 4 congestive heart failure Immune deficiency disease or known history of HIV, HBV, HCV Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents Pregnancy (assessed by urine HCG) Breast feeding Any active autoimmune disease requiring treatment, with the exception of vitiligo Active pulmonary disease requiring medication to include multiple inhalers (>3 inhalers including one containing steroids) Involved in other experimental protocols except with permission of other PI

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

COL (ret) George E Peoples, MD, FACS

Organizational Affiliation

LumaBridge

Official's Role

Study Director

Facility Information:

Facility Name

Sarcoma Oncology Research Center, LLC

City

Santa Monica

State/Province

California

ZIP/Postal Code

90403

Country

United States

Facility Name

St Joseph Heritage Healthcare

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95403

Country

United States

Facility Name

Sibley Memorial Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

Facility Name

University of Miami

City

Deerfield Beach

State/Province

Florida

ZIP/Postal Code

33442

Country

United States

Facility Name

Memorial Breast Cancer Center

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

University of Miami

City

Kendall

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Florida Cancer Research Institute

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

University of Miami

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Memorial Hospital of South Bend

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46601

Country

United States

Facility Name

Cancer Center of Kansas

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67212

Country

United States

Facility Name

Medstar Health (Union Memorial Hospital)

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21218-2895

Country

United States

Facility Name

Medstar (Good Samaritan Hospital)

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21239

Country

United States

Facility Name

The Valley Hospital

City

Paramus

State/Province

New Jersey

ZIP/Postal Code

07652

Country

United States

Facility Name

University of New Mexico Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

New Mexico Cancer Care Alliance/Presbyterian Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87110

Country

United States

Facility Name

North Shore Hematology Oncology Associates

City

Bronx

State/Province

New York

ZIP/Postal Code

10469

Country

United States

Facility Name

Tisch Cancer Institute/Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Texas Oncology (Cancer Care Centers of South Texas)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

University of Virginia Human Immune Therapy Center

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Providence Regional Medical Center

City

Everett

State/Province

Washington

ZIP/Postal Code

98201

Country

United States

Facility Name

Ascension/ Columbia St. Mary's

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53211

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients

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