Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients

Study Overview
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Brief Summary
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Breast cancer, a leading cause of cancer-related mortality in women worldwide, has spurred the investigation of novel therapeutic approaches. Pentoxifylline (PTX), a synthetic methylxanthine derivative, has shown promise in preclinical studies when combined with conventional anticancer drugs. This study aims to assess PTX's impact when added to neoadjuvant chemotherapy protocols in breast cancer patients, with the goal of improving treatment outcomes and reducing associated toxicities.

Official Title
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Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Drug: Pentoxifylline Oral Tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female patients >18 years old with histologic confirmation of invasive breast cancer Planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/ cyclophosphamide followed by paclitaxel (AC/T) Adequate hepatic, renal, and bone marrow functions Exclusion Criteria: Patients on treatment regimen of phosphodiesterase inhibitors Patients who are taking antiplatelet or anticoagulant treatment Patients who are allergic to phosphodiesterase inhibitors History of recent hemorrhagic events Active peptic ulcer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pentoxyphyllin group<br>Patients will undergo a treatment plan determined by the multidisciplinary team. This involves four cycles of intravenous (IV) doxorubicin at a dose of 60 mg/m2 along with IV cyclophosphamide at 600 mg/m2 per cycle. Following this, taxane will be administered. Additionally, patients are prescribed 400 mg pentoxifylline tablets to be taken three times daily. | Drug: Pentoxifylline Oral Tablet<br>* Pentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles.<br>* Other names: Intravenous taxane;|
| Placebo Comparator: Control group<br>Patients will undergo a treatment plan determined by the multidisciplinary team. This involves four cycles of intravenous (IV) doxorubicin at a dose of 60 mg/m2 along with IV cyclophosphamide at 600 mg/m2 per cycle. Following this, taxane will be administered. Additionally, patients will take placebo tablets three times daily. | Drug: Placebo<br>* Placebo tablets will be administered orally three times per day through the time of the chemotherapy cycles.<br>* Other names: Intravenous taxane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative reduction in tumor size after neoadjuvant chemotherapy treatment | Radiological relative reduction of tumor size (expressed as the largest diameter in millimeters) after completion of neoadjuvant chemotherapy cycles. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients achieving a pathological complete response | The number of patients achieving a pathological complete response after the completion of neoadjuvant chemotherapy cycles | 6 months | 
| The relative change of left ventricular ejection fraction (LVEF) | The alterations in left ventricular ejection fraction (LVEF) assessed through echocardiography after four cycles of doxorubicin/cyclophosphamide compared to its baseline level | 3 months | 
| The incidence of grade 2 or more of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5 | Assessing the grade of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5 | 2 months | 
| The relative change of liver function tests | The change in liver function tests Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), bilirubin level after neoadjuvant chemotherapy compared to their levels at baseline. | 6 months | 
| The change in Serum Creatinine concentration | The change in Serum Creatinine concentration after neoadjuvant chemotherapy compared to baseline level. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoadjuvant chemotherapy, doxorubicin, cyclophosphamide, paclitaxel, efficacy, toxicity