Clinical trial

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

Name

2023-147-1

Description

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.

Trial arms

Trial start

2023-12-15

Estimated PCD

2024-08-30

Trial end

2024-09-30

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Pentoxifylline Oral Tablet

Pentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles.

Arms:

Pentoxyphyllin group

Other names:

Intravenous doxorubicin, Intravenous cyclophosphamide, Intravenous taxane

Placebo

Placebo tablets will be administered orally three times per day through the time of the chemotherapy cycles.

Arms:

Control group

Other names:

Intravenous doxorubicin, Intravenous cyclophosphamide, Intravenous taxane

Size

Primary endpoint

Relative reduction in tumor size after neoadjuvant chemotherapy treatment

6 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

Updated at

2024-03-15

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug