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

NCT06176339 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2023-147-1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

neoadjuvant chemotherapy; doxorubicin; cyclophosphamide; paclitaxel; efficacy; toxicity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• The number of patients achieving a pathological complete response

  6 months

• The relative change of left ventricular ejection fraction (LVEF)

  3 months

• The incidence of grade 2 or more of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5

  2 months

• The relative change of liver function tests

  6 months

• The change in Serum Creatinine concentration

  6 months

Study Arms (2)

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.

Drug: Pentoxifylline Oral Tablet

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.

Drug: Placebo

Interventions

Pentoxifylline Oral Tablet DRUG

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

Also known as: Intravenous doxorubicin, Intravenous cyclophosphamide, Intravenous taxane

Pentoxyphyllin group

Placebo DRUG

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

Also known as: Intravenous doxorubicin, Intravenous cyclophosphamide, Intravenous taxane

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Oncology center of Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Pentoxifylline

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Omar Hamdy Abdelaleem, PhD

  Oncology Center, Faculty of medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 19, 2023
• Study Start: December 15, 2023
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

EG (1)