Trial Outcomes & Findings for Lapatinib for Treatment of Ductal Carcinoma In Situ (DCIS) of the Breast (NCT NCT00857714)

Last Updated: 2015-07-08

Results Overview

Number of patients where gene signature was obtained. This was used to identify gene signature that denotes effect of lapatinib therapy in breast cancer cell lines and to assess effect of lapatinib therapy in patients with ductal carinoma in situ of the breast using the gene signature developed as a surrogate marker.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

Up to 60 days

Results posted on

2015-07-08

Participant Flow

Thirty patients were expected for this trial but it stopped at one patient due to difficulty with recruitment.

Participant milestones

Participant milestones
Measure	1500 mg Lapatinib for 14-21 Days Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lapatinib for Treatment of Ductal Carcinoma In Situ (DCIS) of the Breast

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1500 mg Lapatinib for 14-21 Days n=1 Participants Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 60 days

Outcome measures

Outcome measures
Measure	1500 mg Lapatinib for 14-21 Days n=1 Participants Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
Number of Patients Where Gene Signature Was Obtained.	1 participants

SECONDARY outcome

Timeframe: Up to 60 days

Number of patients with toxicity associated with short therapy with lapatinib will be reported.

Outcome measures

Outcome measures
Measure	1500 mg Lapatinib for 14-21 Days n=1 Participants Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
Number of Patients With Toxicity Associated With Short Therapy With Lapatinib.	1 participants

Adverse Events

1500 mg Lapatinib for 14-21 Days

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1500 mg Lapatinib for 14-21 Days n=1 participants at risk Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
Surgical and medical procedures Wound complication	100.0% 1/1 • Up to 60 days

Other adverse events

Other adverse events
Measure	1500 mg Lapatinib for 14-21 Days n=1 participants at risk Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
Skin and subcutaneous tissue disorders skin rash	100.0% 1/1 • Up to 60 days
Skin and subcutaneous tissue disorders nail changes	100.0% 1/1 • Up to 60 days
Gastrointestinal disorders mouth sores	100.0% 1/1 • Up to 60 days
Gastrointestinal disorders nausea	100.0% 1/1 • Up to 60 days
Gastrointestinal disorders cramping	100.0% 1/1 • Up to 60 days

Additional Information

Sunil Badve, MD

IndianaU

Phone: 317-491-6417

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place