Trial Outcomes & Findings for Phase II Study of Erlotinib, an EGFR Inhibitor in Metastatic EGFR-positive 'Triple Receptor-negative' Breast Cancer (NCT NCT00739063)

Last Updated: 2012-03-15

Results Overview

Time to progression calculated from the date of study entry to the date of disease progression or death. Progression of disease is defined by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, as measurable increase in the smallest dimension of any target or not-target lesion, or the appearance of new lesions, since baseline. Confirmed response based on two tumor assessments (imaging) separated by at least 4 weeks.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Baseline to disease progression, up to 22 months with follow up.

Results posted on

2012-03-15

Participant Flow

Recruitment Period: July 22, 2008 to November 03, 2010. All recruitment done at UT MD Anderson Cancer Center.

Study terminated early due to slow accrual. Eleven patients were enrolled, only three received treatment.

Participant milestones

Participant milestones
Measure	Tarceva Daily Tarceva oral 150 mg daily.
Overall Study STARTED	11
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Tarceva Daily Tarceva oral 150 mg daily.
Overall Study Screen failures	8

Baseline Characteristics

Phase II Study of Erlotinib, an EGFR Inhibitor in Metastatic EGFR-positive 'Triple Receptor-negative' Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tarceva Daily n=11 Participants Tarceva oral 150 mg daily.
Age Continuous	52 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to disease progression, up to 22 months with follow up.

Population: Study terminated early, unable to complete overall analysis due to insufficient data.

Outcome measures

Outcome data not reported

Adverse Events

Tarceva Daily

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tarceva Daily n=3 participants at risk Tarceva oral 150 mg daily.
Gastrointestinal disorders Diarrhea	66.7% 2/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Respiratory, thoracic and mediastinal disorders Pleural effusion	66.7% 2/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Blood and lymphatic system disorders Lymphopenia	66.7% 2/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.

Other adverse events

Other adverse events
Measure	Tarceva Daily n=3 participants at risk Tarceva oral 150 mg daily.
Blood and lymphatic system disorders Alanine aminotransferase	100.0% 3/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Investigations Aspartate aminotransferase increased	66.7% 2/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Investigations Alkaline phosphotase increased	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Blood and lymphatic system disorders Hemoglobin decreased	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Investigations Serum magnesium decreased	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Investigations Serum sodium decreased	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Blood and lymphatic system disorders Lymphopenia	66.7% 2/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Skin and subcutaneous tissue disorders Dermatology/Skin (Other) - skin rash	100.0% 3/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Metabolism and nutrition disorders Stomatitis	100.0% 3/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Gastrointestinal disorders Diarrhea	100.0% 3/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Metabolism and nutrition disorders Metabolic/Laboratory (Other) - carbon dioxide	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Eye disorders Ocular/Visual (Other) - red eyes	66.7% 2/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
General disorders Fatigue	66.7% 2/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
General disorders Localized edema	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Gastrointestinal disorders Anorexia	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Musculoskeletal and connective tissue disorders Myalgia	66.7% 2/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Gastrointestinal disorders Nausea	100.0% 3/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Gastrointestinal disorders Constipation	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Infections and infestations Hand-and-foot syndrome	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Gastrointestinal disorders Vomiting	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Musculoskeletal and connective tissue disorders Musculoskeletal (other) - leg cramping	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Respiratory, thoracic and mediastinal disorders Pulmonary (other) - sore in nostril	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.
Skin and subcutaneous tissue disorders Nail disorder	33.3% 1/3 • 16 months Only 3 of 11 participants received treatment, therefore Adverse Events were only collected on those 3 participants.

Additional Information

Ana Gonzalez-Angulo, MD, MS / Associate Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place