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

Mansoura University

Status and phase: Active, not recruiting; Phase 2

Conditions: Breast Cancer Female

Treatments: Drug: Placebo; Drug: Pentoxifylline Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06176339

2023-147-1

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Pentoxyphyllin group

Active Comparator group

Description:

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.

Treatment:

Drug: Pentoxifylline Oral Tablet

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo