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Drug Information from MedlinePlus 4
Green Tea Extract in Treating Women With Hormone Receptor-Negative Stage I, Stage II, or Stage III Breast Cancer
Last Modified: 4/29/2009     First Published: 8/10/2007  

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Randomized Study of Green Tea Catechin Extract (Polyphenon E) in Women With a History of Hormone Receptor-Negative Stage I-III Breast Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IBiomarker/Laboratory analysis, Prevention, TreatmentActive21 to 65NCIMDA-MDA04-4-01
MDA04-4-01, NCT00516243, MDA-2006-0521, CPMC-IRB-AAAB7638

Trial Description

Purpose:

Green tea extract contains ingredients that may prevent or slow the growth of breast cancer.

This randomized phase I trial is studying the side effects and best dose of green tea extract in treating women with hormone receptor -negative stage I, stage II, or stage III breast cancer.

Eligibility:

Eligibility criteria include the following:

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive green tea extract by mouth twice a day for up to 6 months.

Patients in group two will receive a placebo by mouth twice a day for up to 6 months.

Patients will undergo a core biopsy and mammogram of the uninvolved breast at the beginning of the study and after 6 months. They will also undergo blood and urine sample collection at the beginning of the study and every 2 months for laboratory studies.

Patients will fill out a quality-of-life questionnaire at the beginning of the study and at 6 months.

After finishing treatment, patients will be evaluated for 1 month.

Important:

For more details about this trial, refer to the Health Professional version 6 of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site 7.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Scott Lippman, MD, FACP, Principal investigator
Ph: 713-745-3672

Trial Sites

U.S.A.
New York
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Ph: 212-305-8615
 Memorial Sloan-Kettering Cancer Center
 Clifford Hudis, MD
Ph: 646-888-4551
800-525-2225
Texas
  Houston
 Dan L. Duncan Cancer Center at Baylor College of Medicine
 Powel Brown, MD, PhD
Ph: 713-798-8874
 Email: pbrown@breastcenter.tmc.edu
 M. D. Anderson Cancer Center at University of Texas
 Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas
Ph: 713-792-3245

Registry Information
Official Title Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with a History of Hormone Receptor-Negative Breast Cancer
Trial Start Date 2007-06-25
Trial Completion Date 2009-01-09 (estimated)
Registered in ClinicalTrials.gov NCT00516243 8
Date Submitted to PDQ 2007-07-30
Information Last Verified 2009-04-29
NCI Grant/Contract Number CA16672



Glossary Terms

blood
A tissue with red blood cells, white blood cells, platelets, and other substances suspended in fluid called plasma. Blood takes oxygen and nutrients to the tissues, and carries away wastes.
breast cancer (brest KAN-ser)
Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.
caffeine (ka-FEEN)
A substance found in the leaves and beans of the coffee tree, in tea, yerba mate, guarana berries, and in small amounts in cocoa. It can also be made in the laboratory, and is added to some soft drinks, foods, and medicines. Caffeine increases brain activity, alertness, attention, and energy. It may also increase blood pressure, heart rate, breathing rate, and the loss of water from the body in urine.
chemotherapy (KEE-moh-THAYR-uh-pee)
Treatment with drugs that kill cancer cells.
core biopsy (... BY-op-see)
The removal of a tissue sample with a wide needle for examination under a microscope. Also called core needle biopsy.
dose
The amount of medicine taken, or radiation given, at one time.
eligibility criteria (EH-lih-jih-BIH-lih-tee kry-TEER-ee-uh)
In clinical trials, requirements that must be met for an individual to be included in a study. These requirements help make sure that patients in a trial are similar to each other in terms of specific factors such as age, type and stage of cancer, general health, and previous treatment. When all participants meet the same eligibility criteria, it gives researchers greater confidence that results of the study are caused by the intervention being tested and not by other factors.
estrogen receptor negative (ES-truh-jin reh-SEP-ter NEH-guh-tiv)
Describes cells that do not have a protein to which the hormone estrogen will bind. Cancer cells that are estrogen receptor negative do not need estrogen to grow, and usually do not stop growing when treated with hormones that block estrogen from binding. Also called ER-.
green tea extract
A substance that is being studied in the prevention of cancer. It is made from decaffeinated green tea, and contains chemicals called catechins, which are antioxidants. Also called Polyphenon E.
herbal supplement (ER-bul SUH-pleh-ment)
A product made from a plant that is thought to be useful in treating disease or staying healthy. Herbal supplements are taken by mouth.
hormone receptor (HOR-mone reh-SEP-ter)
A cell protein that binds a specific hormone. The hormone receptor may be on the surface of the cell or inside the cell. Many changes take place in a cell after a hormone binds to its receptor.
laboratory study
Research done in a laboratory. These studies may use test tubes or animals to find out if a drug, procedure, or treatment is likely to be useful. Laboratory studies take place before any testing is done in humans.
mammogram (MAM-o-gram)
An x-ray of the breast.
medication (MEH-dih-KAY-shun)
A legal drug that is used to prevent, treat, or relieve symptoms of a disease or abnormal condition.
metastatic cancer (meh-tuh-STA-tik KAN-ser)
Cancer that has spread from the place in which it started to other parts of the body.
mineral (MIH-neh-rul)
In medicine, a mineral is a nutrient that is needed in small amounts to keep the body healthy. Mineral nutrients include the elements calcium, magnesium, and iron.
oncology (on-KAH-loh-jee)
The study of cancer.
outpatient
A patient who visits a health care facility for diagnosis or treatment without spending the night. Sometimes called a day patient.
phase I trial
The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of the treatments being tested, phase I trials usually include only a small number of patients who have not been helped by other treatments.
placebo
An inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
progesterone receptor negative (proh-JES-teh-rone reh-SEP-ter NEH-guh-tiv)
Describes cells that do not have a protein to which the hormone progesterone will bind. Cancer cells that are progesterone receptor negative do not need progesterone to grow, and usually do not stop growing when treated with hormones that block progesterone from binding. Also called PR-.
quality of life
The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on the quality of life. These studies measure aspects of an individual’s sense of well-being and ability to carry out various activities.
radiation therapy (RAY-dee-AY-shun THAYR-uh-pee)
The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.
randomized clinical trial
A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
recurrent cancer (ree-KER-ent KAN-ser)
Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrence.
side effect
A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.
stage I breast cancer
The tumor is 2 centimeters or smaller and has not spread outside the breast.
stage II breast cancer (... brest KAN-ser)
Stage II is divided into stages IIA and IIB. In stage IIA, (1) no tumor is found in the breast, but cancer is found in the axillary lymph nodes (the lymph nodes under the arm); or (2) the tumor is 2 centimeters or smaller and has spread to the axillary lymph nodes; or (3) the tumor is larger than 2 centimeters but not larger than 5 centimeters and has not spread to the axillary lymph nodes. In stage IIB, the tumor is either (1) larger than 2 centimeters but not larger than 5 centimeters and has spread to the axillary lymph nodes; or (2) larger than 5 centimeters but has not spread to the axillary lymph nodes.
stage III breast cancer (... brest KAN-ser)
Stage III breast cancer is divided into stages IIIA, IIIB, and IIIC. In stage IIIA, (1) no tumor is found in the breast, but cancer is found in axillary (under the arm) lymph nodes that are attached to each other or to other structures, or cancer may be found in lymph nodes near the breastbone; or (2) the tumor is 2 centimeters or smaller and cancer has spread to axillary lymph nodes that are attached to each other or to other structures, or the cancer may have spread to lymph nodes near the breastbone; or (3) the tumor is larger than 2 centimeters but not larger than 5 centimeters and cancer has spread to axillary lymph nodes that are attached to each other or to other structures or cancer may have spread to lymph nodes near the breastbone; or (4) the tumor is larger than 5 centimeters and cancer has spread to axillary lymph nodes that may be attached to each other or to other structures or the cancer may have spread to lymph nodes near the breastbone. In stage IIIB, the tumor may be any size and cancer (1) has spread to the chest wall and/or the skin of the breast; and (2) may have spread to axillary lymph nodes that may be attached to each other or to other structures or the cancer may have spread to lymph nodes near the breastbone. In stage IIIC, no tumor is found in the breast or the tumor may be any size and may have spread to the chest wall and/or the skin of the breast. Cancer has spread to lymph nodes above or below the collarbone and may have spread to axillary lymph nodes or to lymph nodes near the breastbone. In operable stage IIIC, the cancer (1) is found in ten or more axillary lymph nodes; or (2) is found in the lymph nodes below the collarbone; or (3) is found in axillary lymph nodes and in lymph nodes near the breastbone. In inoperable stage IIIC, the cancer has spread to the lymph nodes above the collarbone.
supplementation
Adding nutrients to the diet.
surgery (SER-juh-ree)
A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.
urine (YOOR-in)
Fluid containing water and waste products. Urine is made by the kidneys, stored in the bladder, and leaves the body through the urethra.
vitamin (VY-tuh-min)
A nutrient that the body needs in small amounts to function and stay healthy. Sources of vitamins are plant and animal food products and dietary supplements. Some vitamins are made in the human body from food products. Vitamins are either fat-soluble (can dissolve in fats and oils) or water-soluble (can dissolve in water). Excess fat-soluble vitamins are stored in the body’s fatty tissue, but excess water-soluble vitamins are removed in the urine. Examples are vitamin A, vitamin C, and vitamin E.


Table of Links

1http://www.cancer.gov/clinicaltrials/learning
2http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials
3http://www.cancer.gov/clinicaltrials/learning/questions-to-ask-about-participat
ing
4http://www.nlm.nih.gov/medlineplus/druginformation.html
5http://www.cancer.gov/clinicaltrials/MDA-MDA04-4-01#EntryCriteria_CDR0000557580
6http://www.cancer.gov/clinicaltrials/MDA-MDA04-4-01
7http://cancer.gov/clinicaltrials
8http://clinicaltrials.gov/ct/show/NCT00516243