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Alkylating agent

Cyclophosphamide for Breast Cancer

Phase 1
Waitlist Available
Led By Shipra Gandhi
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to swallow and retain oral medication
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 years
Awards & highlights

Study Summary

This trial is testing a combination of chemokine modulation therapy and standard chemotherapy given before surgery to treat patients with early stage triple negative breast cancer.

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are able to swallow pills and keep them down.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With Dose Limiting Toxicities
Secondary outcome measures
Number of Patients With Pathological Complete Response (pCR)
Overall Survival (OS)
Recurrence-free Survival (RFS)
+1 more

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401
88%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Diarrhoea
31%
Hypokalaemia
31%
Tachycardia
27%
Back pain
27%
Constipation
27%
Hypophosphataemia
23%
B-cell lymphoma
23%
White blood cell count decreased
23%
Tremor
23%
Platelet count decreased
23%
Dizziness
19%
Agitation
19%
Cough
19%
Hypogammaglobulinaemia
19%
Tachypnoea
19%
Oedema peripheral
19%
Neutropenia
19%
Hyponatraemia
15%
Hypomagnesaemia
15%
Dysphagia
15%
Dyspnoea
15%
Chills
15%
Thrombocytopenia
15%
Alanine aminotransferase increased
15%
Sinus tachycardia
12%
Arthralgia
12%
Aspartate aminotransferase increased
12%
Hypoxia
12%
Myalgia
12%
Malaise
12%
Abdominal pain
12%
Pain
12%
Hypertension
12%
Peripheral sensory neuropathy
12%
Vomiting
12%
Covid-19
12%
Hyperglycaemia
8%
Acute myeloid leukaemia
8%
Aphasia
8%
Pancytopenia
8%
Dysuria
8%
Hyperhidrosis
8%
Lymphocyte count decreased
8%
Gait disturbance
8%
Pneumonia
8%
Sepsis
8%
Oral candidiasis
8%
Muscular weakness
8%
Encephalopathy
8%
Somnolence
8%
Blood creatinine increased
8%
Urinary tract infection
8%
Eye pain
8%
Asthenia
8%
Insomnia
4%
Respiratory failure
4%
Syncope
4%
Depression
4%
Covid-19 pneumonia
4%
Embolism
4%
Pleural effusion
4%
Febrile neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

Trial Design

1Treatment groups
Experimental Treatment
Group I: CKM weeks 1-3, doxorubicin, cyclophosphamide)Experimental Treatment7 Interventions
Patients receive celecoxib PO BID, recombinant interferon alfa-2b IV over 20 minutes, and rintatolimod IV on days 1-3 of weeks 1-3, as well as paclitaxel IV over 1 hour once weekly on day 1. Treatment continues for a total of 12 weeks in the absence of disease progression or unacceptable toxicity. 1-3 weeks after last dose of paclitaxel, patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Celecoxib
2019
Completed Phase 4
~1740
Doxorubicin
2012
Completed Phase 3
~7940
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Rintatolimod
2019
Completed Phase 2
~120
Recombinant Interferon Alfa-2b
2019
Completed Phase 2
~150
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
397 Previous Clinical Trials
30,505 Total Patients Enrolled
10 Trials studying Breast Cancer
1,638 Patients Enrolled for Breast Cancer
National Center for Advancing Translational Sciences (NCATS)NIH
316 Previous Clinical Trials
390,644 Total Patients Enrolled
4 Trials studying Breast Cancer
1,866 Patients Enrolled for Breast Cancer
Shipra GandhiPrincipal InvestigatorRoswell Park Cancer Institute
4 Previous Clinical Trials
79 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025