Breast Cancer Female
Conditions
Keywords
neoadjuvant chemotherapy, doxorubicin, cyclophosphamide, paclitaxel, efficacy, toxicity
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.
Interventions
Pentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles.
DRUGPlacebo
Placebo tablets will be administered orally three times per day through the time of the chemotherapy cycles.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed