Clinical trial · Interventional
Defined Green Tea Catechin Extract in Treating Women With Hormone Receptor Negative Stage I-III Breast Cancer
Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women With a History of Hormone Receptor-Negative Breast Cancer
NCT00516243CI-TRIAL-00015601completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor-negative Breast Cancer | — | UNRESOLVED | — |
| Progesterone Receptor-negative Breast Cancer | — | UNRESOLVED | — |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| defined green tea catechin extract | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Procedure | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| quality-of-life assessment | Other | — | UNRESOLVED |
| questionnaire administration | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (defined green tea catechin extract)
- description
- Patients receive defined green tea catechin extract PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: quality-of-life assessment
- Procedure: questionnaire administration
- Procedure: laboratory biomarker analysis
- Drug: defined green tea catechin extract
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: placebo
- Other: quality-of-life assessment
- Procedure: questionnaire administration
- Procedure: laboratory biomarker analysis
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCrew 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