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TerminatedNCT01060345Updated Apr 9, 2020Results posted

A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ

A Phase 2 interventional study of Polyphenon E in Ductal Carcinoma in Situ, sponsored by University of Chicago. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-09.

Sponsored by University of Chicago · Phase 2, Interventional, and Prevention

Why this study was terminated
Drug no longer available
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

The purpose of this study is to find molecular signs (biomarkers) to better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (DCIS).

Read the detailed description

Many studies have shown that green tea may have anti-cancer and anti-inflammatory effects in cancer cells and animal models of breast cancer. Some studies have found that Asian women who drink many cups of green tea have lower rates of breast cancer. Green tea may have an effect on proliferative and inflammatory pathways. Women with ductal carcinoma in situ (DCIS) have been found to have inflammation in the breast tissue surrounding DCIS lesions. Inflammatory pathways are being studied for a possible link to cancer. This study is designed to evaluate changes in biomarkers of proliferation, inflammation, and angiogenesis in response to green tea intake.

02

Conditions studied

  • Ductal Carcinoma in Situ

Keywords

  • DCIS
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 20 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed DCIS by breast core biopsy with a corresponding lesion on breast MRI of at least 1-cm3 in volume.
  • Patients may have undergone treatment with prior chemotherapy if this was greater than 12 months prior to current diagnosis.
  • Age >18 years.
  • ECOG performance status \<2 (Karnofsky >60%)
  • Life expectancy of greater than 12 months.
  • Normal organ and marrow function as defined below:
  • leukocytes >3,000/mcL
  • absolute neutrophil count >1,500/mcL
  • platelets >100,000/mcL
  • total bilirubin within normal institutional limits
  • AST(SGOT) \& ALT(SGPT)within normal institutional limits
  • creatinine \<1.5 times institutional upper limit of normal or creatinine clearance >60 mL/min/1.73 m2
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Patients who have undergone prior excisional biopsy for DCIS.
  • Patients who are unable to undergo MRI due to claustrophobia or other reason.
  • Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study.
  • Patients receiving any other chemotherapy or investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extracts or sensitivity to green tea.
  • Uncontrolled concurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Women with Ductal Carcinoma in Situ

    Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E

    Drug: Polyphenon E

Interventions

  • DrugPolyphenon E

    three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery

    Also known as: Green tea

06

What researchers measure

Primary outcomes

  1. Percent Change in K167 Staining

    Time frame: Prior to starting study and after 4-6 weeks of treatment

Secondary outcomes

  1. Decrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment.

    Time frame: Prior to study start and 4-6 weeks after treatment

  2. Change in Percent Staining of CD68 in Breast Tissue

    Time frame: Prior to study start and 4-6 weeks after treatment

  3. Change in Percent Staining of CD31 in Breast Tissue

    Time frame: Prior to study start and 4-6 weeks after treatment

  4. Change in Percent Staining of VEGF in Breast Tissue

    Time frame: Prior to study start and after 4-6 weeks of treatment

  5. Change in Serum Levels of IGF-1

    Time frame: Prior to study start and after 4-6 weeks of treatment

  6. Safety of Green Tea Ingestion

    Number of patients with adverse event.

    Time frame: 6 weeks

07

Results

Posted Apr 9, 2020

Participant flow

Participant flow — Overall Study
MilestoneWomen With Ductal Carcinoma in Situ
Started20
Completed20
Not completed0

Outcome measures

PrimaryPercent Change in K167 Staining
Time frame:
Prior to starting study and after 4-6 weeks of treatment

No measurements were reported for this outcome.

SecondaryDecrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment.
Time frame:
Prior to study start and 4-6 weeks after treatment

No measurements were reported for this outcome.

SecondaryChange in Percent Staining of CD68 in Breast Tissue
Time frame:
Prior to study start and 4-6 weeks after treatment

No measurements were reported for this outcome.

SecondaryChange in Percent Staining of CD31 in Breast Tissue
Time frame:
Prior to study start and 4-6 weeks after treatment

No measurements were reported for this outcome.

SecondaryChange in Percent Staining of VEGF in Breast Tissue
Time frame:
Prior to study start and after 4-6 weeks of treatment

No measurements were reported for this outcome.

SecondaryChange in Serum Levels of IGF-1
Time frame:
Prior to study start and after 4-6 weeks of treatment

No measurements were reported for this outcome.

SecondarySafety of Green Tea Ingestion

Number of patients with adverse event.

Time frame:
6 weeks
Reported as:
Count of participants · Participants
Safety of Green Tea Ingestion
ParticipantsWomen With Ductal Carcinoma in Situ
Safety of Green Tea Ingestion6

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Women With Ductal Carcinoma in Situ0/20 (0%)0/20 (0%)6/20 (30%)
Most frequent other events
Most frequent other events
EventWomen With Ductal Carcinoma in Situ
AnxietyPsychiatric disorders2/20
HeadacheNervous system disorders2/20
FatigueGeneral disorders1/20
Abdominal painGastrointestinal disorders1/20
Breast painReproductive system and breast disorders1/20
ConstipationGastrointestinal disorders1/20
Rectal hemorrhageGastrointestinal disorders1/20
CoughRespiratory, thoracic and mediastinal disorders1/20
PalpitationsCardiac disorders1/20
Sore throatRespiratory, thoracic and mediastinal disorders1/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)Women With Ductal Carcinoma in Situ
Mean56.8 (43 to 71)
Sex: Female, Male
Sex: Female, Male(Participants)Women With Ductal Carcinoma in Situ
Female20
Male0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Women With Ductal Carcinoma in Situ
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American12
White7
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Women With Ductal Carcinoma in Situ
United States20
08

Study locations

1 site
  • The University of Chicago
    Chicago, Illinois 60637, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01060345
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Feb 2, 2010
Start date
May 2010
Primary completion
Sep 2015
Completion
Sep 2015
Results posted
Apr 9, 2020
Last update
Apr 9, 2020

Study contacts

Nora Jaskowiak, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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