Breast CancerEarly Phase 1NCT01313039
Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer
A Early Phase 1 study testing AZ6244 in people with Breast Cancer, run by University of Miami at 1 site in United States.
Trial summary
If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be possible to effectively use hormonal therapy in these patients resulting in improved outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- AZ6244
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Apr 2014
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female breast cancer patient > 18 years.
- Patients must have biopsy-proven clinical Stage Ic-III invasive breast carcinoma with ≤ 10% ER expression by immunohistochemistry (IHC) analysis.
- Patients must have a pre-treatment baseline core biopsy or incisional biopsy available for additional testing (ER, protein/gene expression analysis).
- Patients must have sufficient tumor remaining following diagnostic biopsy that requires an additional definitive surgical procedure per the standard of care. Planned procedure may include lumpectomy or mastectomy as clinically indicated.
- Patients must have an ECOG Performance Status of 0 - 1.
- Patients must have the ability to understand and willingness to sign an English or a Spanish language written informed consent document.
Who cannot join
- Male breast cancer patient.
- Patients who are pregnant or breast-feeding are excluded from the study due to potential harm to the fetus or nursing infant from the study therapy. Patients of reproductive potential must consent to use of contraception or abstinence to be eligible for the study.
- Patients may not have received prior chemotherapy or hormonal therapy for treatment of the current breast cancer.
- Patients should not have known or strongly suspected BRCA mutation by history (genetic testing not required).
- Patients will have pre-study testing, including history and physical exam, complete blood count, and measurement of renal and hepatic function. Patients will be ineligible for the study if significant abnormalities are detected, in accordance with good medical practice.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be possible to effectively use hormonal therapy in these patients resulting in improved outcomes. The investigators propose a single-arm Simon two-step study to examine whether treatment with AZD6244 will result in increased ER expression in ER-negative/low primary breast tumors.
- Conditions
- Breast Cancer
- Being tested
- AZ6244
- Keywords
- Breast Cancer, ER-negative, Allred Score
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZ6244Drug
Also called AZD6244
AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
| Study group | Role | What they receive |
|---|---|---|
| AZD6244 | Experimental | Not described Receives: Drug: AZ6244 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of ER Protein Expression in ER-Negative/Low Breast Cancer
To evaluate in a clinical neoadjuvant model whether MEK inhibitor AZD6244 can increase ER protein expression in ER-negative/low breast cancer, as measured by the "ER response rate" by both standard immunohistochemistry and Allred Score.
Measured: 2 years
Secondary outcomes (3)
Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer
To assess for changes in ER-regulated gene expression in ER-negative/low breast tumors following AZD6244 therapy through assessment of protein expression by immunhistochemistry in paraffin embedded tissues.
Measured: 2 Years
Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer
To determine the rate of ER promoter methylation in ER-negative/low breast cancer tumors that do not attain an ER response following AZD6244 therapy.
Measured: 2 years
In Vitro Tamoxifen Response in Tumors
To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Hurley, MD, Study chair, University of Miami Sylvester Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313039
- Sponsor's protocol ID
- 20100252
- Status last verified
- Dec 2016
- First submitted
- 9 Mar 2011
- Last updated
- 7 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer
- ClinicalTrials.gov ID
- NCT01313039
- Acronym / sponsor ID
- 20100252
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, ER-negative, Allred Score
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Posted 2 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be possible to effectively use hormonal therapy in these patients resulting in improved outcomes. The investigators propose a single-arm Simon two-step study to examine whether treatment with AZD6244 will result in increased ER expression in ER-negative/low primary breast tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD6244 | Experimental | Drug: AZ6244 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female breast cancer patient > 18 years.
- Patients must have biopsy-proven clinical Stage Ic-III invasive breast carcinoma with ≤ 10% ER expression by immunohistochemistry (IHC) analysis.
- Patients must have a pre-treatment baseline core biopsy or incisional biopsy available for additional testing (ER, protein/gene expression analysis).
- Patients must have sufficient tumor remaining following diagnostic biopsy that requires an additional definitive surgical procedure per the standard of care. Planned procedure may include lumpectomy or mastectomy as clinically indicated.
- Patients must have an ECOG Performance Status of 0 - 1.
Key exclusion criteria (5 listed)
- Male breast cancer patient.
- Patients who are pregnant or breast-feeding are excluded from the study due to potential harm to the fetus or nursing infant from the study therapy. Patients of reproductive potential must consent to use of contraception or abstinence to be eligible for the study.
- Patients may not have received prior chemotherapy or hormonal therapy for treatment of the current breast cancer.
- Patients should not have known or strongly suspected BRCA mutation by history (genetic testing not required).
- Patients will have pre-study testing, including history and physical exam, complete blood count, and measurement of renal and hepatic function. Patients will be ineligible for the study if significant abnormalities are detected, in accordance with good medical practice.
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 |
|---|---|---|
| AZ6244Also: AZD6244AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15 | Drug | AZD6244 |
Primary outcome
Increase of ER Protein Expression in ER-Negative/Low Breast Cancer
Time frame: 2 years
To evaluate in a clinical neoadjuvant model whether MEK inhibitor AZD6244 can increase ER protein expression in ER-negative/low breast cancer, as measured by the "ER response rate" by both standard immunohistochemistry and Allred Score.
3 secondary outcomes
Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer
Time frame: 2 Years
Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer
Time frame: 2 years
In Vitro Tamoxifen Response in Tumors
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Judith Hurley, MD study chair
University of Miami Sylvester Comprehensive Cancer Center
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 AZ6244 in people with Breast Cancer, run by University of Miami 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 6 inclusion and 5 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 7 Feb 2017. 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. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Increase of ER Protein Expression in ER-Negative/Low Breast Cancer (time frame: 2 years). 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 7 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.