Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"
- Conditions
- Breast Cancer Female
- Interventions
- Drug: Placebo
- Registration Number
- NCT06176339
- Lead Sponsor
- Mansoura University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pentoxyphyllin group Pentoxifylline Oral Tablet 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. Control group Placebo 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.
- Primary Outcome Measures
Name Time Method Relative reduction in tumor size after neoadjuvant chemotherapy treatment 6 months Radiological relative reduction of tumor size (expressed as the largest diameter in millimeters) after completion of neoadjuvant chemotherapy cycles.
- Secondary Outcome Measures
Name Time Method The number of patients achieving a pathological complete response 6 months The number of patients achieving a pathological complete response after the completion of neoadjuvant chemotherapy cycles
The relative change of left ventricular ejection fraction (LVEF) 3 months The alterations in left ventricular ejection fraction (LVEF) assessed through echocardiography after four cycles of doxorubicin/cyclophosphamide compared to its baseline level
The incidence of grade 2 or more of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5 2 months Assessing the grade of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5
The relative change of liver function tests 6 months 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 6 months The change in Serum Creatinine concentration after neoadjuvant chemotherapy compared to baseline level.
Trial Locations
- Locations (1)
Oncology center of Mansoura University
🇪🇬Mansoura, Egypt