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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00516243
First received: August 14, 2007
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
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
Other: placebo
Procedure: quality-of-life assessment
Procedure: questionnaire administration
Procedure: laboratory biomarker analysis
Drug: defined green tea catechin extract
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • MTD defined as the dose that causes 25% DLT assessed using NCI CTCAE version 3.0 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Breast tissue histology (nonproliferative, proliferative without atypia, atypical hyperplasia) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Generalized linear models will be used.

  • COMT genotype [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Generalized linear models will be used.

  • Quality-of-life measures assessed using SF-36 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Generalized linear models will be used.

  • Protein expression levels in benign breast tissue (Ki-67, p53, EGFR, HER2/neu, cleaved caspase-3, and ER) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Generalized linear models will be used.

  • Quantitative mammographic breast density [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Generalized linear models will be used.

  • Hormone metabolite levels (estradiol, testosterone, IGF-1, IGFBP-3, SHBG) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Generalized linear models will be used.

  • Eicosanoid levels (urine PGE-M) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Generalized linear models will be used.

  • Levels of oxidative damage biomarkers (urine 8-OHdG, isoprostane) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Generalized linear models will be used.

  • Serum CRP levels [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Generalized linear models will be used.


Estimated Enrollment: 40
Study Start Date: July 2007
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (defined green tea catechin extract)
Patients receive defined green tea catechin extract PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Procedure: questionnaire administration
Ancillary studies
Procedure: laboratory biomarker analysis
Correlative studies
Drug: defined green tea catechin extract
Given PO
Other Name: Polyphenon E
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Other: placebo
Given PO
Other Name: PLCB
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Procedure: questionnaire administration
Ancillary studies
Procedure: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516243

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Dawn Hershman M.D. Anderson Cancer Center
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00516243     History of Changes
Other Study ID Numbers: NCI-2009-00858, NCI-2009-00858, IRB-AAAB7638, CDR0000653465, 2006-0521, MDA04-4-01, P30CA016672, N01CN35159
Study First Received: August 14, 2007
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 22, 2014