Breast CancerPhase 2/3NCT04705909
Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer
A Phase 2/3 study testing Pitavastatin in people with Breast Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pitavastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2021to 15 Dec 2021
- Phase
- Phase 2/3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent before any study-specific procedures.
- Histologic confirmation of invasive breast cancer.
- Plans for the administration of neoadjuvant chemotherapy.
- Not currently pregnant during the study
Who cannot join
- Severe gastrointestinal disorder
- Current use of statins or fibrates for any time during the 3 months before the study
- Proven hypersensitivity to statins
- Currently on medication for hypercholesterolemia
- Strong Cytochrome P450 3A4 (abbreviated CYP3A4) (e.g., clarithromycin, HIV protease inhibitors, and itraconazole), given potential interactions with statins
- Renal impairment with a creatinine > 1.4 mg/dl
Show all 12Show fewer
- Hepatic impairment: Aspartate transaminase (AST)/(SGOT), Alanine Transaminase (ALT)/(SGPT) ≥ 2.5 x upper limit of the normal range (ULN), OR Total bilirubin ≥ 1.5 x ULN (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN), OR Alkaline phosphatase > 2.5 x ULN
- Central nervous system (CNS) diseases and major psychiatric diseases or inability to comply with the protocol procedures
- Active infections
- Cardiac failure, class I-IV
- Current anticoagulant or antiplatelet aggregation therapy
- Current lactation
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of pharmacy, Mansoura university
Al Mansurah, 35516
Amal M. Elgayar, professor, 01005157096 ext. 002, elgayaramal@gmail.com
Amal M. Elgayar, Professor
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- Pitavastatin, placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Also called HMG CoA reductase inhibitor " Lipovastatin"
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.
placeboDrug
patients in this group will receive placebo tablets concomitantly with the intended chemotherapy for the treatment period prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin group | Experimental | For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily. Receives: Drug: Pitavastatin |
| 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
The change in Cyclin D1 (candidate marker associated with breast tumor proliferation)
Measured: Baseline up to 6 months
The change in Cleaved caspase-3 (CC3) (candidate marker associated with tumor apoptosis)
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start15 Jan 2021 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Hamdy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705909
- Sponsor's protocol ID
- 2020 - 176
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 12 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36387337
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer
- ClinicalTrials.gov ID
- NCT04705909
- Acronym / sponsor ID
- 2020 - 176
- Conditions
- Breast Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 12 Jan 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin group | Experimental | Drug: PitavastatinFor the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily. |
| Placebo group | Placebo comparator | Drug: placeboFor the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Placebo tablets matching pitavastatin orally once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of informed consent before any study-specific procedures.
- Histologic confirmation of invasive breast cancer.
- Plans for the administration of neoadjuvant chemotherapy.
- Not currently pregnant during the study
Key exclusion criteria (12 listed)
- Severe gastrointestinal disorder
- Current use of statins or fibrates for any time during the 3 months before the study
- Proven hypersensitivity to statins
- Currently on medication for hypercholesterolemia
- Strong Cytochrome P450 3A4 (abbreviated CYP3A4) (e.g., clarithromycin, HIV protease inhibitors, and itraconazole), given potential interactions with statins
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 |
|---|---|---|
| PitavastatinAlso: HMG CoA reductase inhibitor " Lipovastatin"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. | Drug | Pitavastatin group |
| placebopatients in this group will receive placebo tablets concomitantly with the intended chemotherapy for the treatment period prior to surgery. | Drug | Placebo group |
Primary outcome
clinical response rate
Time frame: 6 months
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.
Relative reduction of Ki67 in tumor samples
Time frame: 6 months
It will be described as average pre-post differences in percent positive cells with 95% Wilson confidence intervals.
2 secondary outcomes
The change in Cyclin D1 (candidate marker associated with breast tumor proliferation)
Time frame: Baseline up to 6 months
The change in Cleaved caspase-3 (CC3) (candidate marker associated with tumor apoptosis)
Time frame: Baseline up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Derived from this study: PubMed 36387337Dewidar 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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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pitavastatin in people with Breast Cancer, 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 4 inclusion and 12 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 12 Jan 2021. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Samar A Dewidar, bachelor (01558333468 ext. 002, s.dewidar@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical response rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04705909, which also lists 1 linked publication.
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 12 Jan 2021.