Trial Outcomes & Findings for The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer (NCT NCT03454529)

NCT ID: NCT03454529

Last Updated: 2023-08-01

Results Overview

Differences in % positive cells pre and post treatment along with 95% confidence interval

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Baseline up to 4 weeks
• Results posted on: 2023-08-01

Participant Flow

Participant milestones

Measure	Treatment (Simvastatin) Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Simvastatin: Given PO
Overall Study STARTED	24
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Treatment (Simvastatin) Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Simvastatin: Given PO
Overall Study Did not receive treatment	6
Overall Study Received < 80% doses	1

Baseline Characteristics

The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer

Baseline characteristics by cohort

Measure	Treatment (Simvastatin) n=17 Participants Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Simvastatin: Given PO
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants
Estrogen Receptor Status Positive	15 Participants n=5 Participants
Estrogen Receptor Status Negative	2 Participants n=5 Participants
Progesterone Receptor Status Positive	11 Participants n=5 Participants
Progesterone Receptor Status Negative	6 Participants n=5 Participants
HER2 Status Positive	0 Participants n=5 Participants
HER2 Status Negative	12 Participants n=5 Participants
HER2 Status Unknown	5 Participants n=5 Participants
Tumor Stage Stage 0: limited to the inside of the milk duct; is non-invasive; does not invade nearby tissues.	6 Participants n=5 Participants
Tumor Stage Stage I: Invasive; Primary Tumor < 20mm; No lymph nodes affected; No metastasis.	11 Participants n=5 Participants
Tumor Stage Stage II: Primary Tumor 20-50 mm; 0-<4 lymph nodes in the same side of the breast; No metastasis	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 4 weeks

Population: one patient did not have pre and post measures

Differences in % positive cells pre and post treatment along with 95% confidence interval

Outcome measures

Measure	Treatment (Simvastatin) n=16 Participants Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Simvastatin: Given PO
Change in Ki-67 Expression Assessed in Tumor Tissue by Immunohistochemistry	1.3 percentage of cells expressing Ki67 Interval -3.6 to 6.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 4 weeks

The difference in percentage of cells P27+ from pre-treatment to post-treatment

Outcome measures

Measure	Treatment (Simvastatin) n=16 Participants Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Simvastatin: Given PO
Change in Percentage of Cells P27+ From Pre-treatment to Post-treatment	-1.4 percentage of cells 'biomarker' positive Interval -9.2 to 6.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 4 weeks

The difference in (percentage of cells cleaved caspase-3 (CC3)+) from pre-treatment to post-treatment

Outcome measures

Measure	Treatment (Simvastatin) n=16 Participants Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Simvastatin: Given PO
Cleaved Caspase-3 (CC3) as a Marker of Apoptosis	5.4 percentage of cells expressing CC3 Interval -1.3 to 12.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 4 weeks

Population: This biomarker was not measured.

c-reactive protein (CRP) as a marker of inflammation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 4 weeks

the difference in (% intracellular p27 +) from pre-treatment to post-treatment

Outcome measures

Measure	Treatment (Simvastatin) n=16 Participants Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Simvastatin: Given PO
Change in (% Intracellular p27 +) From Pre-treatment to Post-treatment	0.3 percentage of intracellular p27 + Interval -7.9 to 8.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 4 weeks

the difference in (p27 cytoplasmic intensity) from pre-treatment to post-treatment

Outcome measures

Measure	Treatment (Simvastatin) n=16 Participants Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Simvastatin: Given PO
Changes in p27 Cytoplasmic Intensity	1.8 arbitrary units Interval 0.2 to 3.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 4 weeks

Population: all 16 evaluable participants, except that one patient's sample did not yield cyclin D1 measurement.

the difference in % cyclin D1+ stained out of total cells from pre-treatment to post-treatment;

Outcome measures

Measure	Treatment (Simvastatin) n=15 Participants Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Simvastatin: Given PO
Changes in Cyclin D1	6.1 percentage of total cells cyclin + Interval -2.1 to 14.2

Adverse Events

Treatment (Simvastatin)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment (Simvastatin) n=17 participants at risk Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Simvastatin: Given PO
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	5.9% 1/17 • Number of events 1 • from enrollment up to 18 months
Infections and infestations Bladder infection	5.9% 1/17 • Number of events 1 • from enrollment up to 18 months

Additional Information

Michael Simon,MD

Karmanos Cancer Institute

Phone: 313. 576-8727

Email: simonm@karmanos.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place