Breast CancerPhase 2NCT00917735

Green Tea and Reduction of Breast Cancer Risk

A Phase 2 study testing Green tea extract supplement in people with Breast Cancer, run by University of Minnesota at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer. PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density. Read more about this study

Who is it for?: Ages 50 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer
What is being tested?: Green tea extract supplement
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,075 participants
Where: 5 sitesUnited States
Study dates: Jul 2009to Jun 2014
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 50 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Signed informed consent
Healthy postmenopausal women aged 50-70 years
"Heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts
Willing to avoid consumption of green tea for 1 year

Who cannot join

Positive serological markers of hepatitis B or hepatitis C infections
Elevated levels of liver enzymes
Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors
Current smoker of cigarettes or other tobacco products
BMI <19 or >40 kg/m2
Weight change > 10 lbs during the previous year

Show all 15Show fewer

History of breast cancer or proliferative breast disease
Regular consumption of > 7 alcoholic drinks/wk
Regular consumption of green tea (>1 cup/wk)
Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors
Participation in any weight loss or weight gain studies
Currently taking Methotrexate or Enbrel
History of ovarian cancer
Any form of cancer in the last 5 years
Presence of implants

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Fairview Southdale Breast Center
Edina, Minnesota, 55435
Fairview Maple Grove Breast Center
Maple Grove, Minnesota, 55369
University of Minnesota Medical Center (UMMC) Breast Clinic
Minneapolis, Minnesota, 55455
Park Nicollet Institute
Saint Louis Park, Minnesota, 55426
Food Science and Nutrition, University of Minnesota
Saint Paul, Minnesota, 55108

Other trials in United States

About this study

Official title: Phase II, Randomized,Double-blind, Placebo-controlled, Study of the Efficacy of Green Tea Extract on Biomarkers of Breast Cancer Risk in High Risk Women With Differing Catechol-O-methyl Transferase (COMT) Genotypes

RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer.

PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density.

The investigators have hypothesized that green tea consumption reduces breast cancer risk, and this effect is seen primarily in women who have the low-activity COMT genotype. The investigators will test this by evaluating the effects of green tea extract on breast cancer biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.

Read the detailed description

OBJECTIVES:

Primary: 1.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following recognized biomarkers of breast cancer risk:
Mammographic density
Circulating concentrations of insulin-like growth factor 1 (IGF-1) and IGF binding protein 3 (IGFBP-3)
Circulating concentrations of reproductive hormones (estrone, estradiol, androstenedione) and sex hormone binding globulin (SHBG) 1.2 To determine the effects of COMT genotype on the green tea extract effects described above.
Secondary:

2.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following hypothesized biomarkers of breast cancer risk:

Urinary estrogen metabolites (estrone, estradiol, and their 2-hydroxy, 4-hydroxy, 2-methoxy, and 4-methoxy metabolites, estriol, and 16- hydroxyestrone)
Circulating concentrations of F-2 isoprostanes, a recognized biomarker of systemic oxidative stress

2.2 To determine the effects of COMT genotype on the green tea extract effects described above.

2.3 To determine the effects of COMT genotype on catechin metabolism and excretion, as measured by circulating and urinary concentrations.

Conditions: Breast Cancer
Being tested: Green tea extract supplement, Placebo
Keywords: Green tea, Breast cancer, Prevention, COMT genotype, EGCG (Epigallocatechin gallate), Mammographic density, Reproductive hormones, IGF axis proteins, Oxidative stress
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Green tea extract supplementDrug
Also called Green tea extract: Corban green tea blend (GTB-3D)
Two green tea extract capsules twice daily after breakfast and dinner for one year
PlaceboOther
Also called Sugar Pill
Two placebo capsules twice daily after breakfast and dinner for one year

Study groups in NCT00917735
Study group	Role	What they receive
Green tea extract	Experimental	Green tea extract capsules containing 80.7 % total catechins (51.7 % EGCG) Receives: Drug: Green tea extract supplement
Sugar pill	Placebo comparator	Placebo capsules containing 50% maltodextrin, 49.5 % cellulose, and 0.5 % magnesium stearate Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mammographic Density
Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.
Measured: Baseline and month 12
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Circulating levels of reproductive hormones including estrone, estradiol, androstenedione, testosterone and SHBG were measured in fasting blood samples by liquid chromatography/tandem mass spectrometry method.
Measured: Baseline and month 12
Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3
Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.
Measured: Baseline and month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Jun 2014

First posted10 Jun 2009 (estimated)
Study startJul 2009
Primary completionJun 2014
Study completionJun 2014

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 (6)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe sponsor's other registered studies.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,075 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00917735
Sponsor's protocol ID: 0806M36121
Other IDs: R01CA127236
Status last verified: Jan 2016
First submitted: 8 Jun 2009
Last updated: 22 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Bathgate JR, Radler DR, Kurzer M, Samavat H. Green tea extract supplementation does not modify plasma concentration of F2-isoprostanes in women who are postmenopause: Findings from a randomized controlled trial. Nutr Res. 2023 May;113:29-38. doi: 10.1016/j.nutres.2023.03.001. Epub 2023 Mar 9.
PubMed 37011435
Samavat H, Wu AH, Ursin G, Torkelson CJ, Wang R, Yu MC, Yee D, Kurzer MS, Yuan JM. Green Tea Catechin Extract Supplementation Does Not Influence Circulating Sex Hormones and Insulin-Like Growth Factor Axis Proteins in a Randomized Controlled Trial of Postmenopausal Women at High Risk of Breast Cancer. J Nutr. 2019 Apr 1;149(4):619-627. doi: 10.1093/jn/nxy316.
PubMed 30926986
Arikawa AY, Samavat H, Gross M, Kurzer MS. Plasma F2-isoprostanes Are Positively Associated with Glycemic Load, but Inversely Associated with Dietary Polyunsaturated Fatty Acids and Insoluble Fiber in Postmenopausal Women. J Nutr. 2017 Sep;147(9):1693-1699. doi: 10.3945/jn.117.254631. Epub 2017 Jul 26.
PubMed 28747487
Samavat H, Newman AR, Wang R, Yuan JM, Wu AH, Kurzer MS. Effects of green tea catechin extract on serum lipids in postmenopausal women: a randomized, placebo-controlled clinical trial. Am J Clin Nutr. 2016 Dec;104(6):1671-1682. doi: 10.3945/ajcn.116.137075. Epub 2016 Nov 2.
PubMed 27806972
Dostal AM, Arikawa A, Espejo L, Kurzer MS. Long-Term Supplementation of Green Tea Extract Does Not Modify Adiposity or Bone Mineral Density in a Randomized Trial of Overweight and Obese Postmenopausal Women. J Nutr. 2016 Feb;146(2):256-64. doi: 10.3945/jn.115.219238. Epub 2015 Dec 23.
PubMed 26701796
Dostal AM, Samavat H, Espejo L, Arikawa AY, Stendell-Hollis NR, Kurzer MS. Green Tea Extract and Catechol-O-Methyltransferase Genotype Modify Fasting Serum Insulin and Plasma Adiponectin Concentrations in a Randomized Controlled Trial of Overweight and Obese Postmenopausal Women. J Nutr. 2016 Jan;146(1):38-45. doi: 10.3945/jn.115.222414. Epub 2015 Nov 18.
PubMed 26581683

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II, Randomized,Double-blind, Placebo-controlled, Study of the Efficacy of Green Tea Extract on Biomarkers of Breast Cancer Risk in High Risk Women With Differing Catechol-O-methyl Transferase (COMT) Genotypes
ClinicalTrials.gov ID: NCT00917735
Acronym / sponsor ID: 0806M36121
Conditions: Breast Cancer
Keywords: Green tea, Breast cancer, Prevention, COMT genotype, EGCG (Epigallocatechin gallate), Mammographic density, Reproductive hormones, IGF axis proteins
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,075 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Jul 2009
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 10 Jun 2009 (estimated)
Results: Posted 22 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer.

PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density.

Detailed description

OBJECTIVES:

Primary: 1.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following recognized biomarkers of breast cancer risk:
Mammographic density
Circulating concentrations of insulin-like growth factor 1 (IGF-1) and IGF binding protein 3 (IGFBP-3)
Circulating concentrations of reproductive hormones (estrone, estradiol, androstenedione) and sex hormone binding globulin (SHBG) 1.2 To determine the effects of COMT genotype on the green tea extract effects described above.
Secondary:

2.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following hypothesized biomarkers of breast cancer risk:

Urinary estrogen metabolites (estrone, estradiol, and their 2-hydroxy, 4-hydroxy, 2-methoxy, and 4-methoxy metabolites, estriol, and 16- hydroxyestrone)
Circulating concentrations of F-2 isoprostanes, a recognized biomarker of systemic oxidative stress

2.2 To determine the effects of COMT genotype on the green tea extract effects described above.

2.3 To determine the effects of COMT genotype on catechin metabolism and excretion, as measured by circulating and urinary concentrations.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Green tea extract	Experimental	Drug: Green tea extract supplementGreen tea extract capsules containing 80.7 % total catechins (51.7 % EGCG)
Sugar pill	Placebo comparator	Other: PlaceboPlacebo capsules containing 50% maltodextrin, 49.5 % cellulose, and 0.5 % magnesium stearate

Who may qualify

Ages: 50 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Signed informed consent
Healthy postmenopausal women aged 50-70 years
"Heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts
Willing to avoid consumption of green tea for 1 year

Key exclusion criteria (15 listed)

Positive serological markers of hepatitis B or hepatitis C infections
Elevated levels of liver enzymes
Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors
Current smoker of cigarettes or other tobacco products
BMI <19 or >40 kg/m2

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
Green tea extract supplementAlso: Green tea extract: Corban green tea blend (GTB-3D)Two green tea extract capsules twice daily after breakfast and dinner for one year	Drug	Green tea extract
PlaceboAlso: Sugar PillTwo placebo capsules twice daily after breakfast and dinner for one year	Other	Sugar pill

Primary outcome

Mammographic Density
Time frame: Baseline and month 12
Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Time frame: Baseline and month 12
Circulating levels of reproductive hormones including estrone, estradiol, androstenedione, testosterone and SHBG were measured in fasting blood samples by liquid chromatography/tandem mass spectrometry method.
Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3
Time frame: Baseline and month 12
Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.

Results and safety

Results posted to the registry on 22 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Green Tea Extract	538	463
Sugar Pill	537	474

Primary outcome: Mammographic Density

Time frame: Baseline and month 12. Geometric mean (95% Confidence Interval). Unit: Percent

Measure	Green Tea Extract n = 462	Sugar Pill n = 470
Percent mammographic density at baseline	22.71 (21.39 to 24.10)	21.84 (20.59 to 23.17)
Percent mammographic density at month 12	22.09 (20.77 to 23.50)	21.13 (19.88 to 22.47)

Population analysed: Mammographic density at baseline and month 12

Primary outcome: Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)

Time frame: Baseline and month 12. Geometric mean (95% Confidence Interval). Unit: pg/ml

Measure	Green Tea Extract n = 463	Sugar Pill n = 474
Circulating estrone at baseline	22.8 (21.6 to 24.0)	23.6 (22.4 to 24.9)
Circulating estrone at month 12	22.5 (21.3 to 23.7)	22.4 (21.3 to 23.6)
Circulating estradiol at baseline	3.4 (3.1 to 3.8)	3.7 (3.3 to 4.1)
Circulating estradiol at month 12	3.7 (3.4 to 4.1)	3.1 (2.8 to 3.5)
Circulating androstenedione at baseline	479.8 (459.4 to 501.2)	507.2 (485.9 to 529.5)
Circulating androstenedione at month 12	468.8 (450.2 to 488.3)	479.5 (460.6 to 499.1)
Circulating testosterone at baseline	151.0 (142.7 to 159.7)	161.6 (152.8 to 170.8)
Circulating testosterone at month 12	158.1 (149.9 to 166.9)	155.1 (147.1 to 163.6)

Population analysed: Circulating concentrations of reproductive hormones including estrone, estradiol, androstenedione, testosterone, sex hormone binding globulin (SHBG) at baseline and month 12

Primary outcome: Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3

Time frame: Baseline and month 12. Geometric mean (95% Confidence Interval). Unit: ng/ml

Measure	Green Tea Extract n = 462	Sugar Pill n = 473
Circulating IGF-1 at baseline	87.5 (85.3 to 89.8)	88.3 (86.1 to 90.5)
Circulating IGF-1 at month 12	83.7 (81.6 to 85.8)	83.1 (81.0 to 85.2)
Circulating IGFBP-3 at baseline	2048.0 (2008.9 to 2088.0)	2047.6 (2008.9 to 2087.1)
Circulating IGFBP-3 at month 12	2048.1 (2008.0 to 2089.1)	2040.7 (2001.0 to 2081.0)

Population analysed: Circulating concentrations of IGF axis proteins including insulin-like growth factor (IGF-1) and IGF binding protein 3 (IGFBP-3) at baseline and month 12

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Green Tea Extract	12 of 538 (2.2%)	407 of 538 (75.7%)	Not reported
Sugar Pill	8 of 537 (1.5%)	391 of 537 (72.8%)	Not reported

Limitations and caveats (from the sponsor): We had limited success in recruiting minority populations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37011435Bathgate JR, Radler DR, Kurzer M, Samavat H. Green tea extract supplementation does not modify plasma concentration of F2-isoprostanes in women who are postmenopause: Findings from a randomized controlled trial. Nutr Res. 2023 May;113:29-38. doi: 10.1016/j.nutres.2023.03.001. Epub 2023 Mar 9.
Derived from this study: PubMed 30926986Samavat H, Wu AH, Ursin G, Torkelson CJ, Wang R, Yu MC, Yee D, Kurzer MS, Yuan JM. Green Tea Catechin Extract Supplementation Does Not Influence Circulating Sex Hormones and Insulin-Like Growth Factor Axis Proteins in a Randomized Controlled Trial of Postmenopausal Women at High Risk of Breast Cancer. J Nutr. 2019 Apr 1;149(4):619-627. doi: 10.1093/jn/nxy316.
Derived from this study: PubMed 28747487Arikawa AY, Samavat H, Gross M, Kurzer MS. Plasma F2-isoprostanes Are Positively Associated with Glycemic Load, but Inversely Associated with Dietary Polyunsaturated Fatty Acids and Insoluble Fiber in Postmenopausal Women. J Nutr. 2017 Sep;147(9):1693-1699. doi: 10.3945/jn.117.254631. Epub 2017 Jul 26.
Derived from this study: PubMed 27806972Samavat H, Newman AR, Wang R, Yuan JM, Wu AH, Kurzer MS. Effects of green tea catechin extract on serum lipids in postmenopausal women: a randomized, placebo-controlled clinical trial. Am J Clin Nutr. 2016 Dec;104(6):1671-1682. doi: 10.3945/ajcn.116.137075. Epub 2016 Nov 2.
Derived from this study: PubMed 26701796Dostal AM, Arikawa A, Espejo L, Kurzer MS. Long-Term Supplementation of Green Tea Extract Does Not Modify Adiposity or Bone Mineral Density in a Randomized Trial of Overweight and Obese Postmenopausal Women. J Nutr. 2016 Feb;146(2):256-64. doi: 10.3945/jn.115.219238. Epub 2015 Dec 23.
Derived from this study: PubMed 26581683Dostal AM, Samavat H, Espejo L, Arikawa AY, Stendell-Hollis NR, Kurzer MS. Green Tea Extract and Catechol-O-Methyltransferase Genotype Modify Fasting Serum Insulin and Plasma Adiponectin Concentrations in a Randomized Controlled Trial of Overweight and Obese Postmenopausal Women. J Nutr. 2016 Jan;146(1):38-45. doi: 10.3945/jn.115.222414. Epub 2015 Nov 18.
The Minnesota Green Tea Trial (MGTT), a randomized controlled trial of the efficacy of green tea extract on biomarkers of breast cancer risk: study rationale, design, methods, and participant characteristicsLink provided by the sponsor.
The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: results of the Minnesota Green Tea TrialLink provided by the sponsor.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Mindy S Kurzer, Ph.D principal investigator

University of Minnesota

5 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 Green tea extract supplement in people with Breast Cancer, run by University of Minnesota at 5 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 4 inclusion and 15 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 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. Some participants in this study may receive a placebo. 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 22 Feb 2016). 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?

Mammographic Density (time frame: Baseline and month 12). The study lists 3 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 NCT00917735, which also lists 6 linked publications.

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 22 Feb 2016.