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"

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Drug: Pentoxifylline Oral Tablet; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Oncology Center of Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pentoxyphyllin group; 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; Pentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles.; Other Names: Intravenous doxorubicin; Intravenous cyclophosphamide; Intravenous taxane
Placebo Comparator: Control group; 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; Placebo tablets will be administered orally three times per day through the time of the chemotherapy cycles.; Other Names: Intravenous doxorubicin; Intravenous cyclophosphamide; Intravenous taxane

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Omar Hamdy Abdelaleem, PhD, Oncology Center, Faculty of medicine, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 10, 2023
• First Posted (Actual): December 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: paclitaxel; neoadjuvant chemotherapy; efficacy; cyclophosphamide; toxicity; doxorubicin
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Antirheumatic Agents; Platelet Aggregation Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Taxane; Pentoxifylline
• Other Study ID Numbers: 2023-147-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes