Clinical trial · Interventional
Broccoli Sprout Extract in Treating Patients With Breast Cancer
A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer
NCT01753908CI-TRIAL-00041384completedEarly Phase 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 pilot trial studies broccoli sprout extract in treating patients with breast cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers. Studying samples of tissue from patients receiving broccoli sprout extract may help determine if it can enter breast tumor cells and how it affects certain biomarkers.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Breast Carcinoma | Breast Ductal Carcinoma | ALIAS | 0.90 |
| Ductal Breast Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Estrogen Receptor Negative | — | UNRESOLVED | — |
| Estrogen Receptor Positive | — | UNRESOLVED | — |
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lobular Breast Carcinoma | Breast Lobular Carcinoma | ALIAS | 0.90 |
| Postmenopausal | — | UNRESOLVED | — |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Broccoli Sprout Extract | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (broccoli sprout extract)
- description
- Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.
- interventionNames
- Drug: Broccoli Sprout Extract
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Other: Placebo
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal (no menstrual cycle in the past 12 months) * Diagnosed with incident, primary, invasive, ductal or lobular, or other epithelial malignancy, clinical stage I or II, ER positive or negative breast cancer, or ductal carcinoma in situ (DCIS) * No neoadjuvant endocrine therapy or chemotherapy within 12 months * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Willing to avoid cruciferous vegetable intake during the study period (2 weeks) * Demonstrate the ability to swallow and retain oral medication * Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Prior invasive breast cancer, prior mastectomy or breast radiation within 12 months * Current or recent use of reproductive hormone therapy, tamoxifen, aromatase inhibitor or other estrogen inhibitors within the last 90 days, which may affect biomarkers * Intolerance to broccoli/ITC-BSE taste * Current ingestion of broccoli sprout extract, which may confound study results * Current or recent treatment for any malignancy within the last one year, which may affect biomarkers * History of Crohn's disease, celiac sprue or other malabsorption syndrome which may interfere with digestion and absorption of broccoli sprout extract * Current diagnosis of Gastroesophageal Reflux Disease (GERD) with grade \>3
References
Publications (0)
Data not yet available
No reference posted for this study.