Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

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Platelet Aggregation Inhibitors

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Paclitaxel

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Albumin-Bound Paclitaxel

Pentoxifylline

Taxane

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Alkylating Agents

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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.

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.

Pentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles.

Pentoxifylline Oral Tablet

Placebo tablets will be administered orally three times per day through the time of the chemotherapy cycles.

Placebo

Omar Hamdy Abdelaleem, PhD

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.

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

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

Radiological relative reduction of tumor size (expressed as the largest diameter in millimeters) after completion of neoadjuvant chemotherapy cycles.

The number of patients achieving a pathological complete response after the completion of neoadjuvant chemotherapy cycles

The alterations in left ventricular ejection fraction (LVEF) assessed through echocardiography after four cycles of doxorubicin/cyclophosphamide compared to its baseline level

Assessing the grade of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5

The change in liver function tests Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), bilirubin level after neoadjuvant chemotherapy compared to their levels at baseline.

The change in Serum Creatinine concentration after neoadjuvant chemotherapy compared to baseline level.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"	NCT06176339	Breast Cancer F...	Pentoxifylline ... Placebo	18 Years - 65 Years	Mansoura University
Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"	NCT06176339	Breast Cancer F...	Pentoxifylline ... Placebo	18 Years - 65 Years	Mansoura University
Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"	NCT06176339	Breast Cancer F...	Pentoxifylline ... Placebo	18 Years - 65 Years	Mansoura University

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