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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentoxyphyllin group | Active Comparator | 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. |
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| Control group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline Oral Tablet | Drug | Pentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar Hamdy Abdelaleem, PhD | Oncology Center, Faculty of medicine, Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology center of Mansoura University | Al Mansurah | Egypt |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Placebo | Drug | Placebo tablets will be administered orally three times per day through the time of the chemotherapy cycles. |
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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 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |