Defined Green Tea Catechin Extract in Treating Women With Hormone Receptor Negative Stage I-III Breast Cancer

NCT00516243 | Completed Phase 1

• 7 other identifiers: NCI-2009-00858IRB-AAAB7638CDR00006534652006-0521MDA04-4-01P30CA016672N01CN35159
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

This randomized phase I trial studies the side effects and best dose of defined green tea catechin extract in treating women with hormone receptor-negative stage I-III breast cancer. Green tea extract contains ingredients that may prevent or slow the growth of breast cancer.

Conditions

Estrogen Receptor-negative Breast Cancer; Progesterone Receptor-negative Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer

Outcome Measures

Primary Outcomes (1)

• MTD defined as the dose that causes 25% DLT assessed using NCI CTCAE version 3.0

  6 months

Secondary Outcomes (9)

• Breast tissue histology (nonproliferative, proliferative without atypia, atypical hyperplasia)

  Up to 6 months

• COMT genotype

  Up to 6 months

• Quality-of-life measures assessed using SF-36

  Up to 6 months

• Protein expression levels in benign breast tissue (Ki-67, p53, EGFR, HER2/neu, cleaved caspase-3, and ER)

  Up to 6 months

• Quantitative mammographic breast density

  Up to 6 months

Study Arms (2)

Arm I (defined green tea catechin extract)

EXPERIMENTAL

Patients receive defined green tea catechin extract PO BID for 6 months in the absence of disease progression or unacceptable toxicity.

Other: quality-of-life assessment; Procedure: questionnaire administration; Procedure: laboratory biomarker analysis; Drug: defined green tea catechin extract

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO BID for 6 months in the absence of disease progression or unacceptable toxicity.

Other: placebo; Other: quality-of-life assessment; Procedure: questionnaire administration; Procedure: laboratory biomarker analysis

Interventions

placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Arm I (defined green tea catechin extract); Arm II (placebo)

questionnaire administration PROCEDURE

Ancillary studies

Arm I (defined green tea catechin extract); Arm II (placebo)

laboratory biomarker analysis PROCEDURE

Correlative studies

Arm I (defined green tea catechin extract); Arm II (placebo)

defined green tea catechin extract DRUG

Given PO

Also known as: Polyphenon E

Arm I (defined green tea catechin extract)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Criteria: * History of histologically confirmed stage I, II, or III breast carcinoma without evidence of disease at study entry * No evidence of recurrent disease (patients with resected local recurrence are eligible) * Normal mammogram of the contralateral breast within the past 12 months, defined as no new suspicious calcifications or other abnormal findings warranting a breast biopsy * No history of histologically confirmed bilateral breast cancer * No evidence of metastatic breast cancer * Registered in the outpatient medical oncology clinic at Columbia University Medical Center (CUMC), MD Anderson Cancer Center (MDACC), Memorial Sloan Kettering Cancer Center (MSKCC), or the Weill-Cornell campus of New York Presbyterian Hospital (NYP-WC) * Hormone receptor status: Estrogen- and progesterone-receptor negative * Menopausal status: Pre- or postmenopausal * ECOG performance status \< 2 (Karnofsky \> 60%) * Leukocytes \>= 3,000/uL * Absolute neutrophil count \>= 1,500/uL * Platelets \>= 100,000/uL * Total bilirubin within normal institutional limits * AST/ALT =\< 2.5 times institutional upper limit of normal * Serum creatinine within normal institutional limits * Not pregnant or nursing * Negative pregnancy test * Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extract (Polyphenon E), such as green tea food products or supplements containing EGCG * No history of gastrointestinal bleeding including, but not limited to, any of the following: Diverticulosis; Peptic ulcer disease; Erosive gastritis; Varices * No uncontrolled or significant co-morbid illness including, but not limited to, any of the following: active or serious infection requiring intravenous antibiotics; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; active gastrointestinal bleeding; active liver disease; psychiatric illness/social situations that would limit compliance with study requirements * No active malignancy, except for squamous cell carcinoma of the skin; basal cell carcinoma of the skin; carcinoma in situ; stage IA or IB invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy; or stage IA grade 1 adenocarcinoma of the endometrium treated by surgery * At least 6 months since prior chemotherapy, radiation therapy, and/or breast surgery * No prior radiation therapy or implant in the contralateral breast * More than 30 days since prior and no concurrent medications, herbs, or vitamin and mineral supplements that contain tea compounds or caffeine * At least 30 days since prior and no other concurrent investigational agents * At least 30 days since prior and no concurrent tea consumption * Willing to limit regular coffee consumption to =\< three 8-ounce cups per day for 30 days prior to baseline evaluation and during the study intervention * Total daily caffeine consumption should not exceed 375 mg/day * No concurrent hormone replacement therapy, tamoxifen, or raloxifene * Concurrent oral contraceptives allowed provided the dose has not been changed for at least 6 months prior to study entry * No concurrent chemotherapy or radiation therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• National Institutes of Health (NIH): collaborator

Study Sites (4)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Crew KD, Brown P, Greenlee H, Bevers TB, Arun B, Hudis C, McArthur HL, Chang J, Rimawi M, Vornik L, Cornelison TL, Wang A, Hibshoosh H, Ahmed A, Terry MB, Santella RM, Lippman SM, Hershman DL. Phase IB randomized, double-blinded, placebo-controlled, dose escalation study of polyphenon E in women with hormone receptor-negative breast cancer. Cancer Prev Res (Phila). 2012 Sep;5(9):1144-54. doi: 10.1158/1940-6207.CAPR-12-0117. Epub 2012 Jul 24.

  PMID: 22827973 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

polyphenon E

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dawn Hershman

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 15, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 12, 2014

Record last verified: 2014-04

Locations

US (4)