Trial Outcomes & Findings for Imiquimod for Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases (NCT NCT00899574)

Last Updated: 2015-12-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

9 weeks

Results posted on

2015-12-07

Participant Flow

Ten patients were enrolled to this study between Nov. 2009 and Nov. 2010 at New York University Medical Center and affiliated hospital.

Participant milestones

Participant milestones
Measure	Imiquimod 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 Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imiquimod n=10 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 weeks

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

Outcome measures

Outcome measures
Measure	Imiquimod n=10 Participants 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.
Objective Response (Complete Clinical Response+ Partial Response)	20 percentage of patients Interval 3.0 to 56.0

SECONDARY outcome

Timeframe: 9 weeks

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

This outcome measure is defined as number of patients with improvement of symptoms after 8 weeks of treatment.

Outcome measures

Outcome measures
Measure	Imiquimod n=10 Participants 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.
Clinical Benefits Pain improvement	4 patients
Clinical Benefits Pruritus improvement	5 patients
Clinical Benefits Dermatology Life Quality Index (DLQI) improvement	0 patients

Adverse Events

Imiquimod

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Imiquimod n=10 participants at risk 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.
Gastrointestinal disorders Anorexia	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
Gastrointestinal disorders Dehydration	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	20.0% 2/10 • Number of events 2 • Up to 18 weeks.
Gastrointestinal disorders Diarrhea	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
Gastrointestinal disorders Distension/Bloating, Abdominal	10.0% 1/10 • Number of events 2 • Up to 18 weeks.
Blood and lymphatic system disorders Edema: Limb	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
General disorders Fatigue (Asthenia, Lethargy, Malaise)	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
General disorders Fever (In The Absence Of Neutropenia, Where Neutropenia Is Defined As Anc <1.0 X 10e9/L)	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
General disorders Flu-Like Syndrome	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
General disorders Hemorrhage/Bleeding - Other	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
Infections and infestations Infection With Normal Anc Or Grade 1 Or 2 Neutrophils	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
Nervous system disorders Mood Alteration	10.0% 1/10 • Number of events 6 • Up to 18 weeks.
Gastrointestinal disorders Nausea	20.0% 2/10 • Number of events 8 • Up to 18 weeks.
Nervous system disorders Neurology - Other	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
Nervous system disorders Neuropathy: Sensory	10.0% 1/10 • Number of events 8 • Up to 18 weeks.
General disorders Pain	60.0% 6/10 • Number of events 33 • Up to 18 weeks.
Skin and subcutaneous tissue disorders Pruritus/Itching	30.0% 3/10 • Number of events 6 • Up to 18 weeks.
Skin and subcutaneous tissue disorders Rash/Desquamation	30.0% 3/10 • Number of events 6 • Up to 18 weeks.
Skin and subcutaneous tissue disorders Rash: Hand-Foot Skin Reaction	10.0% 1/10 • Number of events 2 • Up to 18 weeks.
General disorders Rigors/Chills	20.0% 2/10 • Number of events 2 • Up to 18 weeks.
Skin and subcutaneous tissue disorders Skin Breakdown/Decubitus Ulcer	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
Skin and subcutaneous tissue disorders Ulceration	10.0% 1/10 • Number of events 1 • Up to 18 weeks.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 2 • Up to 18 weeks.
General disorders Weight Loss	10.0% 1/10 • Number of events 1 • Up to 18 weeks.

Additional Information

Sylvia Adams, MD

NYU Cancer Institute

Phone: 212-263-6485

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place