Breast CancerPhase 2NCT00676793
A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
A Phase 2 study testing Polyphenon E in people with Breast Cancer, run by Louisiana State University Health Sciences Center Shreveport at 2 sites in United States.
Trial summary
To see if an extract of green tea can affect certain markers of breast cancer and breast cancer progression in women with a recent biopsy positive for cancer and who are scheduled for surgery. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Polyphenon E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2004to Jul 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definitive biopsy demonstrating primary breast cancer
- Residual breast cancer requiring additional surgical resection
- Stage I, II or III disease
- Patient has ability to give signed informed consent
- Normal hepatic and renal function (creatinine<1.5, transaminases <1.5 times upper limit of normal).
- ECOG Performance status of 0 or 1.
- Age ≥ 21 years and less than 75
Who cannot join
- Prior hormonal or surgical therapy for breast cancer
- Abnormal liver function test
- Liver or kidney problems that would interfere with metabolism of study drug
- Any condition that would hamper informed consent or ability to comply with study protocol
- Participation in another research study in the last three months
- Known malignancy at any site other than breast
Show all 9Show fewer
- Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)
- Allergy or intolerance to any component of green tea
- Inability or refusal to comply with definitive surgical therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia Presbyterian Hospital
New York, New York, 10032
LSU Health Sciences Center
Shreveport, Louisiana, 71103
About this study
Official title: Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression
To see if an extract of green tea can affect certain markers of breast cancer and breast cancer progression in women with a recent biopsy positive for cancer and who are scheduled for surgery.
Read the detailed description
To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between breast biopsy and surgery in women with recently diagnosed breast cancer. Endpoints will be changes in serum and tissue biomarkers related to progression of cancer.
The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary objective. Secondary objectives include the effects on the other tissue and serum biomarkers. Evaluation of the safety and tolerability of Polyphenon E in this subject population is another objective.
1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with breast cancer
1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with breast cancer
1.3 Determine the effects of Polyphenon E on MAPK activation in patients with breast cancer
1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in motility and invasion such as Rho GTPases and extracellular proteinases in patients with breast cancer
1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with breast cancer
1.6 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) and Hepatocyte Growth Factor HGF
1.7 Evaluate the safety and tolerability of Polyphenon E in this subject population
- Conditions
- Breast Cancer
- Being tested
- Polyphenon E
- Keywords
- breast cancer, EGCG, Polyphenon E, c-Met, VEGF, HGF
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenon EDrug
Four 200mg capsules daily taken with a meal, for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Polyphenon E | Experimental | This is a single arm study comparing changes within patients before and after receiving the experimental drug Polyphenon E for the duration of the study, between recruitment and surgery for breast cancer. Receives: Drug: Polyphenon E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum VEGF in Breast Cancer
Change in serum VEGF from baseline to post treatment with polyphenon E.
Measured: Baseline and 4 to 6 weeks
Change in Serum HGF and Breast Cancer
Change in serum HGF from baseline to post Polyphenol E treatment.
Measured: Baseline and 4 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startMay 2004
- Primary completionDec 2009
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Jerry McLarty, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Gary Burton, M.D., Principal investigator, LSU Health Sciences Center Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676793
- Sponsor's protocol ID
- H04-179
- Status last verified
- Aug 2017
- First submitted
- 9 May 2008
- Last updated
- 21 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Proffered Oral Presentations - Intervention Studies Abstract PR-05: Effects of presurgical administration of tea polyphenols in women with operable breast cancer Julie L. Campbell1, James Cardelli2, Jerry McLarty2, Dawn Hershman1, Bret Taback1, Susan Refice1, Stephanie Wang2, Rebecca Bigelow2 and Katherine Crew1 1Columbia University Medical Center, New York, NY 2Louisiana State University Health Sciences Center, Shreveport, LA Cancer Prevention Research: December 2010; Volume 3, Issue 12, Supplement 2. doi: 10.1158/1940-6207.PREV-10-PR-05
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression
- ClinicalTrials.gov ID
- NCT00676793
- Acronym / sponsor ID
- H04-179
- Conditions
- Breast Cancer
- Keywords
- breast cancer, EGCG, Polyphenon E, c-Met, VEGF, HGF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- May 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Posted 26 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To see if an extract of green tea can affect certain markers of breast cancer and breast cancer progression in women with a recent biopsy positive for cancer and who are scheduled for surgery.
Detailed description
To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between breast biopsy and surgery in women with recently diagnosed breast cancer. Endpoints will be changes in serum and tissue biomarkers related to progression of cancer.
The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary objective. Secondary objectives include the effects on the other tissue and serum biomarkers. Evaluation of the safety and tolerability of Polyphenon E in this subject population is another objective.
1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with breast cancer
1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with breast cancer
1.3 Determine the effects of Polyphenon E on MAPK activation in patients with breast cancer
1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in motility and invasion such as Rho GTPases and extracellular proteinases in patients with breast cancer
1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with breast cancer
1.6 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) and Hepatocyte Growth Factor HGF
1.7 Evaluate the safety and tolerability of Polyphenon E in this subject population
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polyphenon E | Experimental | Drug: Polyphenon EThis is a single arm study comparing changes within patients before and after receiving the experimental drug Polyphenon E for the duration of the study, between recruitment and surgery for breast cancer. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Definitive biopsy demonstrating primary breast cancer
- Residual breast cancer requiring additional surgical resection
- Stage I, II or III disease
- Patient has ability to give signed informed consent
- Normal hepatic and renal function (creatinine<1.5, transaminases <1.5 times upper limit of normal).
Key exclusion criteria (9 listed)
- Prior hormonal or surgical therapy for breast cancer
- Abnormal liver function test
- Liver or kidney problems that would interfere with metabolism of study drug
- Any condition that would hamper informed consent or ability to comply with study protocol
- Participation in another research study in the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyphenon EFour 200mg capsules daily taken with a meal, for the duration of the study. | Drug | Polyphenon E |
Primary outcome
Change in Serum VEGF in Breast Cancer
Time frame: Baseline and 4 to 6 weeks
Change in serum VEGF from baseline to post treatment with polyphenon E.
Change in Serum HGF and Breast Cancer
Time frame: Baseline and 4 to 6 weeks
Change in serum HGF from baseline to post Polyphenol E treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationProffered Oral Presentations - Intervention Studies Abstract PR-05: Effects of presurgical administration of tea polyphenols in women with operable breast cancer Julie L. Campbell1, James Cardelli2, Jerry McLarty2, Dawn Hershman1, Bret Taback1, Susan Refice1, Stephanie Wang2, Rebecca Bigelow2 and Katherine Crew1 1Columbia University Medical Center, New York, NY 2Louisiana State University Health Sciences Center, Shreveport, LA Cancer Prevention Research: December 2010; Volume 3, Issue 12, Supplement 2. doi: 10.1158/1940-6207.PREV-10-PR-05
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Burton, M.D. principal investigator
LSU Health Sciences Center Shreveport
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polyphenon E in people with Breast Cancer, run by Louisiana State University Health Sciences Center Shreveport at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum VEGF in Breast Cancer (time frame: Baseline and 4 to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00676793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.