Trial Outcomes & Findings for Lapatinib in Metastatic Breast Cancer Resistant to Hormone Therapy (NCT NCT00225758)

NCT ID: NCT00225758

Last Updated: 2018-07-27

Results Overview

A response is defined as stable disease or better at 26 weeks. Twenty two patients are evaluable for response

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

26 weeks

Results posted on

2018-07-27

Participant Flow

Subjects will continue on the same endocrine therapy they had been taking at the time of disease progression.

Participant milestones

Participant milestones
Measure	Endocrine Therapy Plus Lapatinib Subjects will continue on their prior endocrine therapy with the addition of lapatinib at 1500 mg once daily for 26 weeks or longer. Lapatinib: 1500 mg po daily for 26 weeks or longer
Overall Study STARTED	27
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Endocrine Therapy Plus Lapatinib Subjects will continue on their prior endocrine therapy with the addition of lapatinib at 1500 mg once daily for 26 weeks or longer. Lapatinib: 1500 mg po daily for 26 weeks or longer
Overall Study Adverse Event	4

Baseline Characteristics

Lapatinib in Metastatic Breast Cancer Resistant to Hormone Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endocrine Therapy Plus Lapatinib n=27 Participants Subjects will continue on their prior endocrine therapy with the addition of lapatinib at 1500 mg once daily for 26 weeks or longer. Lapatinib: 1500 mg po daily for 26 weeks or longer
Age, Continuous	62 years n=99 Participants
Sex: Female, Male Female	27 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	27 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	27 participants n=99 Participants

PRIMARY outcome

Timeframe: 26 weeks

Population: Of the 27 enrolled subjects, five subjects came off study due to toxicity prior to week 14, at the time of the first restaging. The remaining 22 subjects are evaluable for response.

A response is defined as stable disease or better at 26 weeks. Twenty two patients are evaluable for response

Outcome measures

Outcome measures
Measure	Endocrine Therapy Plus Lapatinib n=22 Participants Subjects will continue on their prior endocrine therapy with the addition of lapatinib at 1500 mg once daily for 26 weeks or longer. Lapatinib: 1500 mg po daily for 26 weeks or longer
Determine the Response Rate and Progression Free Survival of Hormone Therapy-resistant Patients With Metastatic Breast Cancer Treated With the Same Continued Hormonal Agent With the Addition of Lapatinib.	8 Participants

PRIMARY outcome

Timeframe: Up to 575 days

Progression-free survival is the time between date on study and progression based on RECIST criteria.

Outcome measures

Outcome measures
Measure	Endocrine Therapy Plus Lapatinib n=22 Participants Subjects will continue on their prior endocrine therapy with the addition of lapatinib at 1500 mg once daily for 26 weeks or longer. Lapatinib: 1500 mg po daily for 26 weeks or longer
Progression-free Survival	150 days Interval 95.0 to 300.0

SECONDARY outcome

Timeframe: 26 weeks

Population: All 27 subjects are evaluable for toxicity

Outcome measures

Outcome measures
Measure	Endocrine Therapy Plus Lapatinib n=27 Participants Subjects will continue on their prior endocrine therapy with the addition of lapatinib at 1500 mg once daily for 26 weeks or longer. Lapatinib: 1500 mg po daily for 26 weeks or longer
Determine the Toxicities of the Combination of the Hormonal Agent and Lapatinib in Patients With Metastatic Breast Cancer Severe adverse events · Subjects with the adverse event	0 Participants
Determine the Toxicities of the Combination of the Hormonal Agent and Lapatinib in Patients With Metastatic Breast Cancer Severe adverse events · Subjects without the adverse event	27 Participants
Determine the Toxicities of the Combination of the Hormonal Agent and Lapatinib in Patients With Metastatic Breast Cancer Adverse events with a frequency of 5% or more · Subjects with the adverse event	23 Participants
Determine the Toxicities of the Combination of the Hormonal Agent and Lapatinib in Patients With Metastatic Breast Cancer Adverse events with a frequency of 5% or more · Subjects without the adverse event	4 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: None of the patients had the recommended biopsies done as the biopsies were optional, and over half the patients had either bone-only disease or only non-biopsiable soft tissue disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 weeks

Population: Plasma DNA assays were not done due to difficulty obtaining plasma specimens from the outside sites, and technical problems with the assay in the specimens collected at our institution..

Outcome measures

Outcome data not reported

Adverse Events

Lapatinib Plus Endocrine Therapy

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lapatinib Plus Endocrine Therapy n=27 participants at risk Subjects receive lapatinib 1500 mg daily in addition to their prior endocrine therapy.
Gastrointestinal disorders Grade 3 diarrhea	18.5% 5/27 • Number of events 8
Gastrointestinal disorders Grade 2 diarrhea	44.4% 12/27 • Number of events 21
Infections and infestations Grade 3 cellulitis	11.1% 3/27 • Number of events 3
Blood and lymphatic system disorders Grade 3 hypokalemia	11.1% 3/27 • Number of events 3
Blood and lymphatic system disorders Grade 2 anemia	11.1% 3/27 • Number of events 3
Gastrointestinal disorders Grade 2 vomiting	7.4% 2/27 • Number of events 4
Gastrointestinal disorders Grade 2 nausea	7.4% 2/27 • Number of events 3
Investigations Grade 2 lymphopenia	18.5% 5/27 • Number of events 7
General disorders Grade 2 fatigue	18.5% 5/27 • Number of events 5
Skin and subcutaneous tissue disorders Grade 2 rash	11.1% 3/27 • Number of events 4
Metabolism and nutrition disorders Grade 2 weight loss	7.4% 2/27 • Number of events 2
Musculoskeletal and connective tissue disorders Grade 2 skeletal pain	7.4% 2/27 • Number of events 2
General disorders Grade 2 edema	7.4% 2/27 • Number of events 2

Additional Information

Gary N. Schwartz, MD

Dartmouth-Hitchcock Medical Center

Phone: (603) 653-6181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place