Evaluation of the effects of simvastatin in metastatic breast cancer patients

Evaluation of the effects of lipophilic statins on the responsiveness of metastatic breast cancer patients to chemotherapy regimens

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12964275

Enrollment

Registered

2019-10-11

Start date

2011-08-11

Completion date

Unknown

Last updated

2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic breast cancer Cancer Malignant neoplasm of breast

Interventions

Patients were randomly allocated to receive a 15-day course of either simvastatin (40 mg) or placebo at the day -7 of each chemotherapy cycle. Chemotherapy regimen was conducted every

carboplatin (Carboplatin “Ebewe”), Area under the curve (AUC) 4, intravenously on day 1 and vinorelbine (Navelbine®) intravenously (25 mg/m2) or orally (60 mg/m2) on days 1 and 8 of each cycle. Simvas

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female patients attending the breast cancer unit at Al-Baironi Hospital 2. Confirmed diagnosis of metastases (stage IV) prior to commencing chemotherapy course consisting of carboplatin and vinorelbine 3. Age between 20 and 75 years 4. Adequate function of major organs (including cardiac, hepatic and renal functions) 5. ECOG Performance Status score =2

Exclusion criteria

Exclusion criteria: 1. Pregnant patients 2. Previous treatment with statins or carboplatin and vinorelbine within 30 days of the study

Design outcomes

Primary

Measure	Time frame
1. Objective response rate (ORR) calculated based on both complete response + partial response. Patients’ response classified according to the response evaluation criteria in solid tumor (RECIST) (version 1.1) as follows: complete response (CR): complete disappearance of clinical evidence of disease for a minimum of 8 weeks; partial response (PR): decreased in tumor burden =30%; stable disease (SD): decreased by <30% or increased by <20%; progressive disease (PD): increase in tumor burden by =20%; and non-evaluable response due to specific reasons (e.g., early death or toxicity). To assess tumor progression, physical examination, tumor markers (carcinoembryonic antigen (CEA) and cancer antigen 15–3 (CA15-3)), and radiological studies were conducted at baseline and every three cycles, and bone scan was repeated by the end of the sixth cycle 2. Treatment related-toxicity graded according to the Common Terminology Criteria for Adverse Events, version 4 at each cycle	—

Measure

Time frame

1. Objective response rate (ORR) calculated based on both complete response + partial response. Patients’ response classified according to the response evaluation criteria in solid tumor (RECIST) (version 1.1) as follows: complete response (CR): complete disappearance of clinical evidence of disease for a minimum of 8 weeks; partial response (PR): decreased in tumor burden =30%; stable disease (SD): decreased by <30% or increased by <20%; progressive disease (PD): increase in tumor burden by =20%; and non-evaluable response due to specific reasons (e.g., early death or toxicity). To assess tumor progression, physical examination, tumor markers (carcinoembryonic antigen (CEA) and cancer antigen 15–3 (CA15-3)), and radiological studies were conducted at baseline and every three cycles, and bone scan was repeated by the end of the sixth cycle 2. Treatment related-toxicity graded according to the Common Terminology Criteria for Adverse Events, version 4 at each cycle

—

Secondary

Measure	Time frame
Overall survival defined as the time from study entry to death from any cause over the follow-up period (the follow-up lasted until death or the cutoff date of July 2017)	—

Countries

Syria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026