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Different modalities for breast cancer treatments have exhausting and distressing side effects and toxicities leading to decreased compliance. Thus, repurposing drugs with accepted safety profile and possible antitumor activity becomes an eminent constraint.
Statins have been reported to have possible advantages as anticancer, and control of cancer progression. Moreover, they can sensitize cancer cells for radiotherapy. Therefore, the investigators aim to investigate the effect of (pitavastatin) added to conventional chemotherapy protocols for breast cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin group | Experimental | For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily. |
|
| Placebo group | Placebo Comparator | For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Placebo tablets matching pitavastatin orally once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | Pitavastatin 2 mg oral tablets daily will be given to the patients concomitantly with the intended chemotherapy protocol for the treatment period prior to surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical response rate | Response to preoperative therapy as per ultrasonographic tumor size assessment. A responder will have > 50% decrease in the size of the primary tumor without appearance of new lesions. | 6 months |
| Relative reduction of Ki67 in tumor samples | It will be described as average pre-post differences in percent positive cells with 95% Wilson confidence intervals. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The change in Cyclin D1 (candidate marker associated with breast tumor proliferation) | Baseline up to 6 months | |
| The change in Cleaved caspase-3 (CC3) (candidate marker associated with tumor apoptosis) | Baseline up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samar A Dewidar, bachelor | Contact | 01558333468 | 002 | s.dewidar@mans.edu.eg |
| Omar H Abdelaleem, PHD | Contact | 01003526752 | 002 | omarhamdy87@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of pharmacy, Mansoura university | Al Mansurah | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36387337 | Derived | Dewidar SA, Hamdy O, Eltantawy A, El-Mesery M, El Gayar AM, Soliman MM. Effect of concomitant use of pitavastatin with neoadjuvant chemotherapy protocols in breast cancer patients: A randomized controlled clinical trial. Saudi Pharm J. 2022 Oct;30(10):1486-1496. doi: 10.1016/j.jsps.2022.07.011. Epub 2022 Jul 25. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
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|
| placebo | Drug | patients in this group will receive placebo tablets concomitantly with the intended chemotherapy for the treatment period prior to surgery. |
|
| D017437 |
| Skin and Connective Tissue Diseases |