Trial Outcomes & Findings for A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression (NCT NCT00676793)

Results Overview

Change in serum VEGF from baseline to post treatment with polyphenon E.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

Baseline and 4 to 6 weeks

Results posted on

2017-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	ECGC and Breast Cancer Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
Overall Study STARTED	32
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ECGC and Breast Cancer n=32 Participants Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	51.8 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4 to 6 weeks

Population: Number of participants for analysis was determined per protocol.

Change in serum VEGF from baseline to post treatment with polyphenon E.

Outcome measures

Outcome measures
Measure	ECGC and Breast Cancer n=19 Participants Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
Change in Serum VEGF in Breast Cancer	270 pg/ml Interval -142.5 to 581.25

PRIMARY outcome

Timeframe: Baseline and 4 to 6 weeks

Population: Number of participants for analysis was determined per protocol.

Change in serum HGF from baseline to post Polyphenol E treatment.

Outcome measures

Outcome measures
Measure	ECGC and Breast Cancer n=19 Participants Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
Change in Serum HGF and Breast Cancer	155.0 pg/ml Interval -143.75 to 700.625

Adverse Events

ECGC and Breast Cancer

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ECGC and Breast Cancer n=32 participants at risk Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
Gastrointestinal disorders Stomach Cramps	6.2% 2/32 • Number of events 2
Renal and urinary disorders Increase in amylase and lypase	3.1% 1/32 • Number of events 1

Additional Information

Dr. Jerry w. McLarty, Ph.D.

LSU Health, Shreveport

Phone: (318)813-1446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place