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Cyclophosphamide for Breast Cancer
Phase 1
Waitlist Available
Led By David Page, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Availability of at least one tumor-bearing core specimen from the breast cancer diagnostic biopsy
Invasive breast cancer of any receptor subtype diagnosed by core-needle biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1-26
Awards & highlights
Study Summary
This trial is testing a new cancer treatment to see if it is safe and effective.
Who is the study for?
This trial is for adults over 18 with early stage breast cancer, who are planning to have surgery and chemotherapy. It's specifically for those with a certain type of aggressive breast cancer (triple-negative) and tumors larger than 5 mm. Participants need to be in good health overall, as shown by their Karnofsky Performance status.Check my eligibility
What is being tested?
The study tests the IRX-2 regimen's safety and how well patients respond before standard chemo. The regimen includes Cyclophosphamide, Indomethacin, Omeprazole, and Multivitamin given pre-operatively to see if it improves outcomes in triple-negative breast cancer cases.See study design
What are the potential side effects?
Possible side effects from the IRX-2 regimen may include reactions related to immune system activation such as fever or fatigue; digestive issues due to Omeprazole; potential liver function changes from Indomethacin; and risks typically associated with Cyclophosphamide like hair loss or bladder irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a breast cancer biopsy sample available.
Select...
My breast cancer was diagnosed with a needle biopsy.
Select...
I am planning surgery or have triple-negative breast cancer for specific treatment.
Select...
I am mostly able to care for myself and carry out daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1-26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1-26
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Establish the Safety of the IRX-2 Regimen When Administered Pre-operatively in Early Stage Breast Cancer (ESBC) Patients
Secondary outcome measures
Tumor Infiltrating Lymphocytes
Other outcome measures
Characterization of Peripheral Lymphocytes
Intratumoral Immune Response
Intratumoral T-cell Clonality Response
+1 moreSide effects data
From 2023 Phase 2 trial • 27 Patients • NCT0400240188%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Hypokalaemia
31%
Diarrhoea
31%
Tachycardia
27%
Constipation
27%
Back pain
27%
Hypophosphataemia
23%
Dizziness
23%
Platelet count decreased
23%
Tremor
23%
B-cell lymphoma
23%
White blood cell count decreased
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Hypogammaglobulinaemia
19%
Hyponatraemia
19%
Tachypnoea
19%
Agitation
15%
Alanine aminotransferase increased
15%
Thrombocytopenia
15%
Chills
15%
Dyspnoea
15%
Hypomagnesaemia
15%
Sinus tachycardia
15%
Dysphagia
12%
Hypertension
12%
Vomiting
12%
Abdominal pain
12%
Aspartate aminotransferase increased
12%
Pain
12%
Malaise
12%
Myalgia
12%
Hypoxia
12%
Arthralgia
12%
Hyperglycaemia
12%
Covid-19
12%
Peripheral sensory neuropathy
8%
Hyperhidrosis
8%
Aphasia
8%
Pancytopenia
8%
Muscular weakness
8%
Pneumonia
8%
Encephalopathy
8%
Eye pain
8%
Gait disturbance
8%
Oral candidiasis
8%
Urinary tract infection
8%
Sepsis
8%
Blood creatinine increased
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Somnolence
8%
Dysuria
8%
Asthenia
8%
Lymphocyte count decreased
4%
Pleural effusion
4%
Covid-19 pneumonia
4%
Respiratory failure
4%
Febrile neutropenia
4%
Embolism
4%
Depression
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination
Trial Design
2Treatment groups
Experimental Treatment
Group I: IRX-2 Regimen -Triple Negative Breast CancerExperimental Treatment4 Interventions
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.
Group II: IRX-2 Regimen -Early Stage Breast CancerExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Indomethacin
2011
Completed Phase 4
~4130
Omeprazole
2006
Completed Phase 4
~940
Multivitamin
2016
Completed Phase 4
~20750
Find a Location
Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,519 Total Patients Enrolled
7 Trials studying Breast Cancer
4,608 Patients Enrolled for Breast Cancer
Brooklyn ImmunoTherapeutics, LLCIndustry Sponsor
7 Previous Clinical Trials
5,464 Total Patients Enrolled
1 Trials studying Breast Cancer
12 Patients Enrolled for Breast Cancer
David Page, MDPrincipal InvestigatorProvidence Health & Services
5 Previous Clinical Trials
65 Total Patients Enrolled
3 Trials studying Breast Cancer
24 Patients Enrolled for Breast Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Cyclophosphamide a suitable therapeutic option with minimal risk?
"Due to the limited data regarding its efficacy and safety, Cyclophosphamide received a score of 1 on our team's assessment scale."
Answered by AI
What maladies can Cyclophosphamide be administered to combat?
"Cyclophosphamide is a viable therapeutic option for those who have not responded to traditional treatments for gastroesophageal reflux disease, multiple sclerosis, or any other condition."
Answered by AI
Has Cyclophosphamide been utilized in any other research studies?
"Currently, there exist 836 ongoing Cyclophosphamide trials; 157 of which are in their final stages. Although the bulk of these tests take place in Philadelphia, Pennsylvania, they can be found at nearly 28 thousand locations worldwide."
Answered by AI
What is the enrollment capacity of this research initiative?
"Unfortunately, no more patients can be recruited for this trial as recruitment closed at the end of January 2022. If you are looking to participate in a clinical study related to male breast cancer or cyclophosphamide, there are 4586 and 836 trials respectively that may suit your needs."
Answered by AI
Are there any remaining vacancies for subjects in this clinical trial?
"This trial is not currently recruiting new patients. It was initially posted on February 9th 2017 and last updated January 31st 2022. If you are searching for alternate studies, there are 4586 clinical trials looking to recruit participants with male breast cancer and 836 trials actively enrolling people who take Cyclophosphamide."
Answered by AI
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