Breast CancerPhase 2NCT00899574

Imiquimod for Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases

A Phase 2 study testing Imiquimod in people with Breast Cancer and Breast Neoplasms, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this trial is to determine the safety and efficacy of Imiquimod, a Toll-like receptor 7 agonist in breast cancer (for chestwall recurrences or metastases to the skin). Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Breast Neoplasms
What is being tested?: Imiquimod
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: May 2009to Jun 2013
Phase: Phase 2
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

Patients with biopsy-confirmed breast cancer (prior histological documentation is acceptable).
Patients with measurable skin metastases (chest wall recurrence and/or non-chest wall skin metastases are eligible).
Skin metastases not suitable for or patient refusing definitive surgical resection and radiation.
(Cohort 1) Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) is allowed if distant metastases have been non-progressing (stable or responding) on that regimen for > or = 12 weeks and skin metastases are non-responsive (stable or progressing) as assessed by the investigator.
(Cohort 2) Any concurrent systemic therapy is allowed
Age at least 18 years.

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Eastern Cooperative Oncology Group (ECOG) performance status < or = 2.
Patients must have biopsy-accessible tumor (skin metastases) and agree to biopsies required by protocol.
Patients must have adequate organ and bone marrow function as defined below:
absolute neutrophil count > or = 1,500/microliter
hemoglobin > or = 9.5 grams/deciliter
platelets >or = 75,000/microliter
total bilirubin < or = 1.5 X institutional upper limit of normal
Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) < or = 2.5X institutional upper limit of normal
creatinine < or = 1.5 X institutional upper limit of normal
Informed consent.

Who cannot join

Brain metastases unless resected or irradiated and stable > or = 8 weeks.
Treatment with other investigational agents.
Patients who have received radiotherapy, high-potency corticosteroids, intralesional therapy, laser therapy or surgery other than biopsy to the target area within 4 weeks prior to first dosing of study agent.
Patients who have received hyperthermia to the target area within 10 weeks prior to first dosing of study agent.
Patients with an uncontrolled bleeding disorder.
Patients who will be therapeutically anticoagulated with heparins or coumadin at the time of the biopsy (they are eligible if anticoagulation can be held prior to biopsy as per investigator). Patients on aspirin and other platelet agents are eligible.

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Patients with known immunodeficiency or receiving immunosuppressive therapies.
History of allergic reactions to imiquimod or its excipients.
Uncontrolled intercurrent medical illness or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnancy or lactation.
Women of childbearing potential not using a medically acceptable means of contraception.

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Cancer Institute
New York, New York, 10016

Other trials in United States

About this study

Official title: Phase II Evaluation of Imiquimod, a Topical Toll-like Receptor 7 (TLR7) Agonist in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases

The purpose of this trial is to determine the safety and efficacy of Imiquimod, a Toll-like receptor 7 agonist in breast cancer (for chestwall recurrences or metastases to the skin).

Read the detailed description

TLR agonists are novel agents for cancer therapy which modify the immune response. Imiquimod, a synthetic TLR7 agonist has proven immunomodulatory activity when applied topically, leading to clearance of human papilloma virus (HPV)-induced genital warts and primary skin malignancies. Its effects will now be examined in breast cancer metastatic to the skin. If effective, it will add a relatively non-toxic approach to the treatment armamentarium for this patient population frequently resistant to conventional therapies.

Conditions: Breast Cancer, Breast Neoplasms
Being tested: Imiquimod
Keywords: toll-like receptor, toll-like receptor agonist, recurrent breast cancer, breast cancer metastasized to skin and/or chestwall, immunomodulator
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ImiquimodDrug
Also called Aldara
Each treatment cycle consists of 8 weeks.
Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.
Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease.

Study groups in NCT00899574
Study group	Role	What they receive
Imiquimod	Experimental	Each treatment cycle consists of 8 weeks. Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period. Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease. Receives: Drug: Imiquimod

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response (Complete Clinical Response+ Partial Response)
This is defined as percentage of patients who achieved complete clinical response or partial response at end of cycle 1 of treatment. The tumor size will be measured as lesion surface area (region of interest, ROI). The response to the treatment is then evaluated as a function of post-treatment over pre-treatment ROI, expressed in percentage. Response criteria for this study are based on European Organisation for Research and Treatment of Cancer definitions for chest wall tumors: complete clinical response: absence of any detectable residual disease; partial response: <50% of ROI change.
Measured: 9 weeks

Secondary outcomes (1)

Clinical Benefits
This outcome measure is defined as number of patients with improvement of symptoms after 8 weeks of treatment.
Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Jun 2013

First posted12 May 2009 (estimated)
Study startMay 2009
Primary completionApr 2011
Study completionJun 2013

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe 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: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00899574
Sponsor's protocol ID: NYU 09-0225
Status last verified: Nov 2015
First submitted: 11 May 2009
Last updated: 7 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Adams S, Kozhaya L, Martiniuk F, Meng TC, Chiriboga L, Liebes L, Hochman T, Shuman N, Axelrod D, Speyer J, Novik Y, Tiersten A, Goldberg JD, Formenti SC, Bhardwaj N, Unutmaz D, Demaria S. Topical TLR7 agonist imiquimod can induce immune-mediated rejection of skin metastases in patients with breast cancer. Clin Cancer Res. 2012 Dec 15;18(24):6748-57. doi: 10.1158/1078-0432.CCR-12-1149. Epub 2012 Jul 5.
PubMed 22767669

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Evaluation of Imiquimod, a Topical Toll-like Receptor 7 (TLR7) Agonist in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
ClinicalTrials.gov ID: NCT00899574
Acronym / sponsor ID: NYU 09-0225
Conditions: Breast Cancer, Breast Neoplasms
Keywords: toll-like receptor, toll-like receptor agonist, recurrent breast cancer, breast cancer metastasized to skin and/or chestwall, immunomodulator
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: May 2009
Primary completion: Apr 2011 (actual)
Study completion: Jun 2013 (actual)
First posted: 12 May 2009 (estimated)
Results: Posted 11 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this trial is to determine the safety and efficacy of Imiquimod, a Toll-like receptor 7 agonist in breast cancer (for chestwall recurrences or metastases to the skin).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Imiquimod	Experimental	Drug: ImiquimodEach treatment cycle consists of 8 weeks. Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period. Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Patients with biopsy-confirmed breast cancer (prior histological documentation is acceptable).
Patients with measurable skin metastases (chest wall recurrence and/or non-chest wall skin metastases are eligible).
Skin metastases not suitable for or patient refusing definitive surgical resection and radiation.
(Cohort 1) Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) is allowed if distant metastases have been non-progressing (stable or responding) on that regimen for > or = 12 weeks and skin metastases are non-responsive (stable or progressing) as assessed by the investigator.
(Cohort 2) Any concurrent systemic therapy is allowed

Key exclusion criteria (11 listed)

Brain metastases unless resected or irradiated and stable > or = 8 weeks.
Treatment with other investigational agents.
Patients who have received radiotherapy, high-potency corticosteroids, intralesional therapy, laser therapy or surgery other than biopsy to the target area within 4 weeks prior to first dosing of study agent.
Patients who have received hyperthermia to the target area within 10 weeks prior to first dosing of study agent.
Patients with an uncontrolled bleeding disorder.

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
ImiquimodAlso: AldaraEach treatment cycle consists of 8 weeks. Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period. Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease.	Drug	Imiquimod

Primary outcome

Objective Response (Complete Clinical Response+ Partial Response)
Time frame: 9 weeks
This is defined as percentage of patients who achieved complete clinical response or partial response at end of cycle 1 of treatment. The tumor size will be measured as lesion surface area (region of interest, ROI). The response to the treatment is then evaluated as a function of post-treatment over pre-treatment ROI, expressed in percentage. Response criteria for this study are based on European Organisation for Research and Treatment of Cancer definitions for chest wall tumors: complete clinical response: absence of any detectable residual disease; partial response: <50% of ROI change.

1 secondary outcome

Clinical Benefits
Time frame: 9 weeks

Results and safety

Results posted to the registry on 11 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Imiquimod	10	10

Primary outcome: Objective Response (Complete Clinical Response+ Partial Response)

Time frame: 9 weeks. Number (95% Confidence Interval). Unit: percentage of patients

Measure	Imiquimod n = 10
Value	20 (3 to 56)

Population analysed: Patients who completed 1 cycle of treatment (8 weeks) and response evaluation at week 9.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 18 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Imiquimod	0 of 10 (0%)	10 of 10 (100%)	Not reported

Limitations and caveats (from the sponsor): The 20% response rate would have justified to continue; but the study was concluded and a new trial of imiquimod and local radiotherapy (NCT01421017) is open, based on preclinical findings indicating that the combination was more effective.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22767669Adams S, Kozhaya L, Martiniuk F, Meng TC, Chiriboga L, Liebes L, Hochman T, Shuman N, Axelrod D, Speyer J, Novik Y, Tiersten A, Goldberg JD, Formenti SC, Bhardwaj N, Unutmaz D, Demaria S. Topical TLR7 agonist imiquimod can induce immune-mediated rejection of skin metastases in patients with breast cancer. Clin Cancer Res. 2012 Dec 15;18(24):6748-57. doi: 10.1158/1078-0432.CCR-12-1149. Epub 2012 Jul 5.

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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.

Sylvia Adams, MD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imiquimod in people with Breast Cancer and Breast Neoplasms, run by NYU Langone Health 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 16 inclusion and 11 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 Dec 2015. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 May 2012). 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?

Objective Response (Complete Clinical Response+ Partial Response) (time frame: 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00899574, which also lists 1 linked publication.

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 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.