Breast NeoplasmPhase 1NCT02950259
Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
A Phase 1 study testing Cyclophosphamide, Indomethacin and Omeprazole in people with Breast Neoplasm and Breast Neoplasm, Male, run by Providence Health & Services at 1 site in United States.
Trial summary
The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients with early stage breast cancer (ESBC) and to estimate the pathologic complete response rate to neoadjuvant anthracycline-based and non-platinum containing chemotherapy in patients with triple-negative breast cancer who have… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasm, Breast Neoplasm, Male, Triple Negative Breast Cancer
- What is being tested?
- Cyclophosphamide, Indomethacin and Omeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2017to 25 Sep 2025
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Invasive breast cancer of any receptor subtype diagnosed by core-needle biopsy
- To undergo surgical resection with curative intent by partial mastectomy (lumpectomy) or mastectomy or
- Triple negative breast cancer (defined by ER<10%, PR<10%, and HER2-negative by NCCN guidelines), T1c+ tumors for which neoadjuvant anthracycline-based and non-platinum containing chemotherapy is planned
- Tumor >5 mm in maximum diameter by ultrasound or mammography. (Subjects with smaller tumors may be included at the discretion of the Principal Investigator.)
- Willing and able to provide written informed consent, including consent for use of available tissue and required blood draws for research purposes
- Availability of at least one tumor-bearing core specimen from the breast cancer diagnostic biopsy
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- Karnofsky Performance status (KPS) 70% or greater.
- Female or male ≥18 years of age on day of signing informed consent.
- Adequate organ function as defined by protocol specified lab results
Who cannot join
- Prior neoadjuvant systemic therapy is planned
- Prior surgery, radiotherapy or chemotherapy for this cancer (other than core-needle biopsy)
- Received an investigational agent within 4 weeks of the first dose of treatment.
- Diagnosis of immunodeficiency or has received more than replacement doses of corticosteroids any other immunosuppressive therapy within 4 weeks of the first dose of treatment
- Hypersensitivity to IRX 2, cyclophosphamide, indomethacin, aspirin or ciprofloxacin.
- Chronic anticoagulation, not including aspirin, but including heparins, warfarin, oral anticoagulants or other platelet function inhibitors, that cannot, in the documented opinion of the investigator, safely be interrupted from at least 2 days prior to the initiation of the study regimen until after surgical resection of the tumor.
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- Another malignancy that required active treatment within 6 months of the first dose of treatment
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, such that trial participation is not in the best interest of the subject, including but not limited to uncontrolled hypertension or clinically significant cardiovascular disease, myocardial infarction within the previous 3 months, active infection or pneumonitis or other pulmonary disease requiring systemic therapy, clinically significant gastritis or peptic ulcer disease (that would preclude the use of indomethacin), stroke of other symptoms of cerebral vascular insufficient within the last 3 months, autoimmune disease that has required systemic treatment within the past 2 years (other than hormone replacement doses), or uncontrolled psychiatric or substance abuse disorders.
- Pregnancy or lactation.
- Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
Official title: A Phase Ib Study to Assess the Safety, Tolerability and Immunologic Activity of Preoperative IRX 2 In Early Stage Breast Cancer
The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients with early stage breast cancer (ESBC) and to estimate the pathologic complete response rate to neoadjuvant anthracycline-based and non-platinum containing chemotherapy in patients with triple-negative breast cancer who have received the IRX-2 Regimen before chemotherapy.
Read the detailed description
This will be a Phase Ib study conducted to determine the safety and tolerability of an IRX-2 regimen in ESBC, to be administered pre-operatively before standard-of-care surgical resection and following standard-of-care diagnostic biopsy. This study will also include triple-negative breast cancer patients who will receive the IRX-2 regimen prior to chemotherapy.
Eligible subjects will have early stage breast cancer of any receptor sub-type, for which standard-of-care surgical resection is planned. To be eligible, a minimum of 1 core of tumor-bearing biopsy material must be available for research analysis.
Cohort B will enroll subjects triple negative breast cancer (defined by ER<10%, PR<10%, and HER2-negative by NCCN guidelines), T1c+ tumors for which neoadjuvant anthracycline-based and non-platinum containing chemotherapy is planned. The IRX-2 regimen will be administered and completed preceding chemotherapy. Cohort B subjects must undergo post-IRX-2 Regimen biopsy (2-3 cores), followed by commencement of chemotherapy preferably within one week after biopsy.
The IRX-2 regimen will be administered in all enrolled subjects. IRX 2 will be administered by subcutaneous injection into the periareolar skin of the affected breast.
- Being tested
- Cyclophosphamide, Indomethacin, Omeprazole, Multivitamin
- Keywords
- Breast Cancer, Early Stage Breast Cancer, Male breast cancer, IRX-2, Immunotherapy, Triple Negative Breast Cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Cytoxan
One dose of cyclophosphamide 300 mg/m2 IV infusion
IndomethacinDrug
Also called Indocin
Indomethacin 25 mg three times a day for 21 days
OmeprazoleDrug
Also called Prilosec
One tablet of omeprazole daily for 21 days
MultivitaminDietary supplement
Also called Vitamin
Daily multivitamin containing 15-30 mg of zinc for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| IRX-2 Regimen -Early Stage Breast Cancer | Experimental | Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. Receives: Drug: Cyclophosphamide; Drug: Indomethacin; Drug: Omeprazole; Dietary Supplement: Multivitamin |
| IRX-2 Regimen -Triple Negative Breast Cancer | Experimental | Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. Receives: Drug: Cyclophosphamide; Drug: Indomethacin; Drug: Omeprazole; Dietary Supplement: Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the Safety of the IRX-2 Regimen When Administered Pre-operatively in Early Stage Breast Cancer (ESBC) Patients
The safety of IRX-2 will be determined by any surgical delays associated with administration of the study regimen.
Measured: Day 1 to Day 26
Secondary outcomes (1)
Tumor Infiltrating Lymphocytes
Change in tumor infiltrating lymphocyte (TIL) score as measured by hematoxylin and eosin tumor infiltrating lymphocytes (H\&E TIL) count according to Salgado criteria from pre-surgical biopsy to resected tumor specimen
Measured: At time of pre-surgical biopsy and time of tumor specimen resection at day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start9 Feb 2017
- Primary completion13 May 2019
- Study completion25 Sep 2025
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Brooklyn ImmunoTherapeutics, LLC
- Responsible party
- Sponsor
- Investigators
- David Page, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950259
- Sponsor's protocol ID
- 16-126B
- Other IDs
- IRX-2 2016-B
- Status last verified
- Nov 2025
- First submitted
- 28 Oct 2016
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Providence Health \& Services has agreed to allow IRX Therapeutics to have access PHI for auditing purposes. Any non-Providence Health \& Services employee who will access PHI will be required to sign a confidentiality agreement and will not be permitted to remove PHI from Providence Health \& Services.
Publications
Sanchez K, Kim I, Chun B, Pucilowska J, Redmond WL, Urba WJ, Martel M, Wu Y, Campbell M, Sun Z, Grunkemeier G, Chang SC, Bernard B, Page DB. Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer. Breast Cancer Res. 2021 Jan 7;23(1):2. doi: 10.1186/s13058-020-01378-4.
PubMed 33413574
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Assess the Safety, Tolerability and Immunologic Activity of Preoperative IRX 2 In Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02950259
- Acronym / sponsor ID
- 16-126B
- Keywords
- Breast Cancer, Early Stage Breast Cancer, Male breast cancer, IRX-2, Immunotherapy, Triple Negative Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Brooklyn ImmunoTherapeutics, LLC
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients with early stage breast cancer (ESBC) and to estimate the pathologic complete response rate to neoadjuvant anthracycline-based and non-platinum containing chemotherapy in patients with triple-negative breast cancer who have received the IRX-2 Regimen before chemotherapy.
Detailed description
This will be a Phase Ib study conducted to determine the safety and tolerability of an IRX-2 regimen in ESBC, to be administered pre-operatively before standard-of-care surgical resection and following standard-of-care diagnostic biopsy. This study will also include triple-negative breast cancer patients who will receive the IRX-2 regimen prior to chemotherapy.
Eligible subjects will have early stage breast cancer of any receptor sub-type, for which standard-of-care surgical resection is planned. To be eligible, a minimum of 1 core of tumor-bearing biopsy material must be available for research analysis.
Cohort B will enroll subjects triple negative breast cancer (defined by ER<10%, PR<10%, and HER2-negative by NCCN guidelines), T1c+ tumors for which neoadjuvant anthracycline-based and non-platinum containing chemotherapy is planned. The IRX-2 regimen will be administered and completed preceding chemotherapy. Cohort B subjects must undergo post-IRX-2 Regimen biopsy (2-3 cores), followed by commencement of chemotherapy preferably within one week after biopsy.
The IRX-2 regimen will be administered in all enrolled subjects. IRX 2 will be administered by subcutaneous injection into the periareolar skin of the affected breast.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRX-2 Regimen -Early Stage Breast Cancer | Experimental | Drug: Cyclophosphamide, Drug: Indomethacin, Drug: Omeprazole, Dietary Supplement: MultivitaminEnrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. |
| IRX-2 Regimen -Triple Negative Breast Cancer | Experimental | Drug: Cyclophosphamide, Drug: Indomethacin, Drug: Omeprazole, Dietary Supplement: MultivitaminEnrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Invasive breast cancer of any receptor subtype diagnosed by core-needle biopsy
- To undergo surgical resection with curative intent by partial mastectomy (lumpectomy) or mastectomy or
- Triple negative breast cancer (defined by ER<10%, PR<10%, and HER2-negative by NCCN guidelines), T1c+ tumors for which neoadjuvant anthracycline-based and non-platinum containing chemotherapy is planned
- Tumor >5 mm in maximum diameter by ultrasound or mammography. (Subjects with smaller tumors may be included at the discretion of the Principal Investigator.)
- Willing and able to provide written informed consent, including consent for use of available tissue and required blood draws for research purposes
Key exclusion criteria (10 listed)
- Prior neoadjuvant systemic therapy is planned
- Prior surgery, radiotherapy or chemotherapy for this cancer (other than core-needle biopsy)
- Received an investigational agent within 4 weeks of the first dose of treatment.
- Diagnosis of immunodeficiency or has received more than replacement doses of corticosteroids any other immunosuppressive therapy within 4 weeks of the first dose of treatment
- Hypersensitivity to IRX 2, cyclophosphamide, indomethacin, aspirin or ciprofloxacin.
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 |
|---|---|---|
| CyclophosphamideAlso: CytoxanOne dose of cyclophosphamide 300 mg/m2 IV infusion | Drug | IRX-2 Regimen -Early Stage Breast Cancer, IRX-2 Regimen -Triple Negative Breast Cancer |
| IndomethacinAlso: IndocinIndomethacin 25 mg three times a day for 21 days | Drug | IRX-2 Regimen -Early Stage Breast Cancer, IRX-2 Regimen -Triple Negative Breast Cancer |
| OmeprazoleAlso: PrilosecOne tablet of omeprazole daily for 21 days | Drug | IRX-2 Regimen -Early Stage Breast Cancer, IRX-2 Regimen -Triple Negative Breast Cancer |
| MultivitaminAlso: VitaminDaily multivitamin containing 15-30 mg of zinc for 21 days. | Dietary supplement | IRX-2 Regimen -Early Stage Breast Cancer, IRX-2 Regimen -Triple Negative Breast Cancer |
Primary outcome
Establish the Safety of the IRX-2 Regimen When Administered Pre-operatively in Early Stage Breast Cancer (ESBC) Patients
Time frame: Day 1 to Day 26
The safety of IRX-2 will be determined by any surgical delays associated with administration of the study regimen.
1 secondary outcome
Tumor Infiltrating Lymphocytes
Time frame: At time of pre-surgical biopsy and time of tumor specimen resection at day 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33413574Sanchez K, Kim I, Chun B, Pucilowska J, Redmond WL, Urba WJ, Martel M, Wu Y, Campbell M, Sun Z, Grunkemeier G, Chang SC, Bernard B, Page DB. Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer. Breast Cancer Res. 2021 Jan 7;23(1):2. doi: 10.1186/s13058-020-01378-4.
- Providence Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Providence Health \& Services has agreed to allow IRX Therapeutics to have access PHI for auditing purposes. Any non-Providence Health \& Services employee who will access PHI will be required to sign a confidentiality agreement and will not be permitted to remove PHI from Providence Health \& Services.
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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.
David Page, MD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide, Indomethacin and Omeprazole in people with Breast Neoplasm and Breast Neoplasm, Male, run by Providence Health & Services at 1 site in United States.
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 9 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 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 30 Jan 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?
Establish the Safety of the IRX-2 Regimen When Administered Pre-operatively in Early Stage Breast Cancer (ESBC) Patients (time frame: Day 1 to Day 26). 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 NCT02950259, which also lists 1 linked publication.
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 3 Dec 2025.