Ductal Breast CarcinomaEarly Phase 1NCT01753908
Broccoli Sprout Extract in Treating Patients With Breast Cancer
A Early Phase 1 study testing Broccoli Sprout Extract, Laboratory Biomarker Analysis and Pharmacological Study in people with Ductal Breast Carcinoma and Ductal Breast Carcinoma In Situ, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Ductal Breast Carcinoma, Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative
- What is being tested?
- Broccoli Sprout Extract, Laboratory Biomarker Analysis and Pharmacological Study
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2013to 23 Aug 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether isothiocyanate-rich broccoli sprout extract (ITC-BSE) modifies biomarkers in breast tumor cells.
II. To determine whether the intervention alters proliferative and apoptotic markers (Ki-67 and cleaved caspase-3).
III. To determine whether the intervention down-regulates the expression of estrogen receptor (ER) including both ERalpha and ERbeta.
IV. To determine whether the intervention induces NAD(P)H dehydrogenase (quinone) 1 (NQO1) expression.
SECONDARY OBJECTIVES:
- To determine tolerability of ITC-BSE and compliance in breast cancer patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive broccoli sprout extract orally (PO) once daily (QD) on days 1-14 immediately prior to surgery.
ARM II: Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
After completion of study treatment, patients are followed up at 30 days.
- Conditions
- Ductal Breast Carcinoma, Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative, Estrogen Receptor Positive, Invasive Breast Carcinoma, Lobular Breast Carcinoma
- Being tested
- Broccoli Sprout Extract, Laboratory Biomarker Analysis, Pharmacological Study, Placebo
- Medical subject headings
- Carcinoma, Ductal, Breast, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Lobular, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli Sprout ExtractDrug
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Urinary ITCs and metabolites measured
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (broccoli sprout extract) | Experimental | Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery. Receives: Drug: Broccoli Sprout Extract; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO QD on days 1-14 immediately prior to surgery. Receives: Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in apoptosis (cleaved caspase 3)
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Measured: Baseline to up to 14 days
Changes in cell proliferation (Ki-67)
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Measured: Baseline to up to 14 days
Changes in estrogen receptor expression (ER alpha and ER beta)
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Measured: Baseline to up to 14 days
Changes in NQO1 expression
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Measured: Baseline to up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study start21 May 2013
- Primary completion23 Jul 2018
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jessica Young, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753908
- Sponsor's protocol ID
- I 211911
- Other IDs
- NCI-2012-01770, I 211911, K07CA148888, P30CA016056
- Status last verified
- Oct 2019
- First submitted
- 10 Dec 2012
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT01753908
- Acronym / sponsor ID
- I 211911
- Conditions
- Ductal Breast Carcinoma, Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative, Estrogen Receptor Positive, Invasive Breast Carcinoma, Lobular Breast Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 May 2013 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine whether isothiocyanate-rich broccoli sprout extract (ITC-BSE) modifies biomarkers in breast tumor cells.
II. To determine whether the intervention alters proliferative and apoptotic markers (Ki-67 and cleaved caspase-3).
III. To determine whether the intervention down-regulates the expression of estrogen receptor (ER) including both ERalpha and ERbeta.
IV. To determine whether the intervention induces NAD(P)H dehydrogenase (quinone) 1 (NQO1) expression.
SECONDARY OBJECTIVES:
- To determine tolerability of ITC-BSE and compliance in breast cancer patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive broccoli sprout extract orally (PO) once daily (QD) on days 1-14 immediately prior to surgery.
ARM II: Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
After completion of study treatment, patients are followed up at 30 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (broccoli sprout extract) | Experimental | Drug: Broccoli Sprout Extract, Other: Laboratory Biomarker Analysis, Other: Pharmacological StudyPatients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery. |
| Arm II (placebo) | Placebo comparator | Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Other: PlaceboPatients receive placebo PO QD on days 1-14 immediately prior to surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broccoli Sprout ExtractGiven PO | Drug | Arm I (broccoli sprout extract) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (broccoli sprout extract), Arm II (placebo) |
| Pharmacological StudyUrinary ITCs and metabolites measured | Other | Arm I (broccoli sprout extract), Arm II (placebo) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO | Other | Arm II (placebo) |
Primary outcome
Changes in apoptosis (cleaved caspase 3)
Time frame: Baseline to up to 14 days
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Changes in cell proliferation (Ki-67)
Time frame: Baseline to up to 14 days
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Changes in estrogen receptor expression (ER alpha and ER beta)
Time frame: Baseline to up to 14 days
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Changes in NQO1 expression
Time frame: Baseline to up to 14 days
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Young principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Broccoli Sprout Extract, Laboratory Biomarker Analysis and Pharmacological Study in people with Ductal Breast Carcinoma and Ductal Breast Carcinoma In Situ, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in apoptosis (cleaved caspase 3) (time frame: Baseline to up to 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.