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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00899574
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : May 11, 2012
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Breast Neoplasms
Intervention Drug: Imiquimod
Enrollment 10
Recruitment Details Ten patients were enrolled to this study between Nov. 2009 and Nov. 2010 at New York University Medical Center and affiliated hospital.
Pre-assignment Details  
Arm/Group Title Imiquimod
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Imiquimod
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  90.0%
>=65 years
1
  10.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
50
(44 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
10
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Objective Response (Complete Clinical Response+ Partial Response)
Hide Description 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.
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed 1 cycle of treatment (8 weeks) and response evaluation at week 9.
Arm/Group Title Imiquimod
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
20
(3 to 56)
2.Secondary Outcome
Title Clinical Benefits
Hide Description This outcome measure is defined as number of patients with improvement of symptoms after 8 weeks of treatment.
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed 1 cycle of treatment (8 weeks) and response evaluation at week 9.
Arm/Group Title Imiquimod
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: patients
Pain improvement 4
Pruritus improvement 5
Dermatology Life Quality Index (DLQI) improvement 0
Time Frame Up to 18 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Imiquimod
Hide Arm/Group Description

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.

All-Cause Mortality
Imiquimod
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Imiquimod
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Imiquimod
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Blood and lymphatic system disorders   
Edema: Limb  1  1/10 (10.00%)  1
Gastrointestinal disorders   
Anorexia  1  1/10 (10.00%)  1
Dehydration  1  1/10 (10.00%)  1
Diarrhea  1  1/10 (10.00%)  1
Distension/Bloating, Abdominal  1  1/10 (10.00%)  2
Nausea  1  2/10 (20.00%)  8
Vomiting  1  1/10 (10.00%)  2
General disorders   
Fatigue (Asthenia, Lethargy, Malaise)  1  1/10 (10.00%)  1
Fever (In The Absence Of Neutropenia, Where Neutropenia Is Defined As Anc <1.0 X 10e9/L)  1  1/10 (10.00%)  1
Flu-Like Syndrome  1  1/10 (10.00%)  1
Hemorrhage/Bleeding - Other  1  1/10 (10.00%)  1
Pain  1  6/10 (60.00%)  33
Rigors/Chills  1  2/10 (20.00%)  2
Weight Loss  1  1/10 (10.00%)  1
Infections and infestations   
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils  1  1/10 (10.00%)  1
Nervous system disorders   
Mood Alteration  1  1/10 (10.00%)  6
Neurology - Other  1  1/10 (10.00%)  1
Neuropathy: Sensory  1  1/10 (10.00%)  8
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/10 (10.00%)  1
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other  1  2/10 (20.00%)  2
Pruritus/Itching  1  3/10 (30.00%)  6
Rash/Desquamation  1  3/10 (30.00%)  6
Rash: Hand-Foot Skin Reaction  1  1/10 (10.00%)  2
Skin Breakdown/Decubitus Ulcer  1  1/10 (10.00%)  1
Ulceration  1  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sylvia Adams, MD
Organization: NYU Cancer Institute
Phone: 212-263-6485
EMail: sylvia.adams@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00899574    
Other Study ID Numbers: NYU 09-0225
First Submitted: May 11, 2009
First Posted: May 12, 2009
Results First Submitted: April 12, 2012
Results First Posted: May 11, 2012
Last Update Posted: December 7, 2015