Breast Cancer FemalePhase 2NCT06176339
Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"
A Phase 2 study testing Pentoxifylline Oral Tablet in people with Breast Cancer Female, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Pentoxifylline Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2023to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: "Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"
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
- Being tested
- Pentoxifylline Oral Tablet, Placebo
- Keywords
- neoadjuvant chemotherapy, doxorubicin, cyclophosphamide, paclitaxel, efficacy, toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline Oral TabletDrug
Also called Intravenous doxorubicin, Intravenous cyclophosphamide, Intravenous taxane
Pentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles.
PlaceboDrug
Also called Intravenous doxorubicin, Intravenous cyclophosphamide, Intravenous taxane
Placebo tablets will be administered orally three times per day through the time of the chemotherapy cycles.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
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
Measured: 6 months
The relative change of left ventricular ejection fraction (LVEF)
The alterations in left ventricular ejection fraction (LVEF) assessed through echocardiography after four cycles of doxorubicin/cyclophosphamide compared to its baseline level
Measured: 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
Measured: 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.
Measured: 6 months
The change in Serum Creatinine concentration
The change in Serum Creatinine concentration after neoadjuvant chemotherapy compared to baseline level.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start15 Dec 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Hamdy, Mansoura University
- Investigators
- Omar Hamdy Abdelaleem, PhD, Principal investigator, Oncology Center, Faculty of medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176339
- Sponsor's protocol ID
- 2023-147-1
- Status last verified
- Mar 2024
- First submitted
- 1 Dec 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"
- ClinicalTrials.gov ID
- NCT06176339
- Acronym / sponsor ID
- 2023-147-1
- Conditions
- Breast Cancer Female
- Keywords
- neoadjuvant chemotherapy, doxorubicin, cyclophosphamide, paclitaxel, efficacy, toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxyphyllin group | Active comparator | Drug: Pentoxifylline Oral TabletPatients 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. |
| Control group | Placebo comparator | Drug: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentoxifylline Oral TabletAlso: Intravenous doxorubicin, Intravenous cyclophosphamide, Intravenous taxanePentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles. | Drug | Pentoxyphyllin group |
| PlaceboAlso: Intravenous doxorubicin, Intravenous cyclophosphamide, Intravenous taxanePlacebo tablets will be administered orally three times per day through the time of the chemotherapy cycles. | Drug | Control group |
Primary outcome
Relative reduction in tumor size after neoadjuvant chemotherapy treatment
Time frame: 6 months
Radiological relative reduction of tumor size (expressed as the largest diameter in millimeters) after completion of neoadjuvant chemotherapy cycles.
5 secondary outcomes
The number of patients achieving a pathological complete response
Time frame: 6 months
The relative change of left ventricular ejection fraction (LVEF)
Time frame: 3 months
The incidence of grade 2 or more of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5
Time frame: 2 months
The relative change of liver function tests
Time frame: 6 months
The change in Serum Creatinine concentration
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Hamdy Abdelaleem, PhD principal investigator
Oncology Center, Faculty of medicine, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pentoxifylline Oral Tablet in people with Breast Cancer Female, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative reduction in tumor size after neoadjuvant chemotherapy treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.