Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

Sponsor

Mansoura University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04705909

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Pitavastatin Drug: placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

Anticipated Study Start Date :

Jan 15, 2021

Anticipated Primary Completion Date :

Sep 15, 2021

Anticipated Study Completion Date :

Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pitavastatin group For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily.	Drug: Pitavastatin 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. Other Names: HMG CoA reductase inhibitor " Lipovastatin"
Placebo Comparator: Placebo group For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Placebo tablets matching pitavastatin orally once daily.	Drug: placebo patients in this group will receive placebo tablets concomitantly with the intended chemotherapy for the treatment period prior to surgery.

Arm

Intervention/Treatment

Experimental: Pitavastatin group

For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily.

Drug: Pitavastatin

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.

Other Names:

HMG CoA reductase inhibitor " Lipovastatin"

Placebo Comparator: Placebo group

For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Placebo tablets matching pitavastatin orally once daily.

Drug: placebo

patients in this group will receive placebo tablets concomitantly with the intended chemotherapy for the treatment period prior to surgery.

Outcome Measures

Primary Outcome Measures

clinical response rate [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 [6 months]
It will be described as average pre-post differences in percent positive cells with 95% Wilson confidence intervals.

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of pharmacy, Mansoura university	Mansoura		Egypt	35516

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Omar Hamdy, Lecturer of Surgical oncology, Principal Investigator, Surgery department., Mansoura University

ClinicalTrials.gov Identifier:

NCT04705909

Other Study ID Numbers:

2020 - 176

First Posted:

Jan 12, 2021

Last Update Posted:

Jan 12, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Pitavastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Study Results

No Results Posted as of Jan 12, 2021