Trial Outcomes & Findings for Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery (NCT NCT00633750)

NCT ID: NCT00633750

Last Updated: 2012-09-05

Results Overview

In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 5-14 days
• Results posted on: 2012-09-05

Participant Flow

Recruitment period = 8/28/2002 through 10/16/2007

54 participants were initially consented for this study. Four were determined to be ineligible. Three participants withdrew from the study before beginning.

Participant milestones

Measure	Tarceva Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
Overall Study STARTED	47
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Tarceva Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery

Baseline characteristics by cohort

Measure	Tarceva n=47 Participants Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age Continuous	56 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 5-14 days

Population: Patients who received the study drug and who had available pre- and post-treatment tissue.

In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.

Outcome measures

Measure	Tarceva n=34 Participants Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva	8 participants

SECONDARY outcome

Timeframe: at 5-14 days

Population: Participants with available pre- and post-treatment tissue and who demonstrated a post-treatment decrease in Ki67 levels compared to their pre-treatment levels

Determined by estrogen receptor status (ER) and human epidermal growth factor receptor 2 (HER2) status, which are measured by staining of 200-500 tumor cells and noting the number stained. Positive = > 10% of cell show staining, negative = < 10% of cells show staining

Outcome measures

Measure	Tarceva n=8 Participants Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
Molecular Profile of Participants Who Are Responsive to Tarceva Estrogen receptor positive	6 participants
Molecular Profile of Participants Who Are Responsive to Tarceva Estrogen receptor negative	2 participants
Molecular Profile of Participants Who Are Responsive to Tarceva HER-2 positive	1 participants
Molecular Profile of Participants Who Are Responsive to Tarceva HER-2 negative	7 participants

SECONDARY outcome

Timeframe: After last dose of Tarceva, at 5-14 days, and before surgery

Population: Participants with blood taken within 24 hours of last dose of erlotinib and before surgery

Post-treatment plasma level in µmol/L of erlotinib hydrochloride

Outcome measures

Measure	Tarceva n=30 Participants Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
Average Post-treatment Plasma Level of Erlotinib Hydrochloride	8.8 µmol/L Standard Deviation 7.4

Adverse Events

Tarceva

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tarceva n=47 participants at risk Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
Respiratory, thoracic and mediastinal disorders Pulmonary ebmolisim	2.1% 1/47 • Number of events 1

Other adverse events

Measure	Tarceva n=47 participants at risk Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
Gastrointestinal disorders Abdominal pain	6.4% 3/47 • Number of events 3
Investigations Alkaline phosphatase	6.4% 3/47 • Number of events 3
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	14.9% 7/47 • Number of events 7
Metabolism and nutrition disorders Anorexia	6.4% 3/47 • Number of events 3
Cardiac disorders Arrhythmia	6.4% 3/47 • Number of events 3
Musculoskeletal and connective tissue disorders Arthiritis	19.1% 9/47 • Number of events 9
Eye disorders Blurred vision	6.4% 3/47 • Number of events 3
Gastrointestinal disorders Constipation	6.4% 3/47 • Number of events 3
Respiratory, thoracic and mediastinal disorders Cough	6.4% 3/47 • Number of events 3
Gastrointestinal disorders Diarrhea	31.9% 15/47 • Number of events 15
General disorders Fatigue	19.1% 9/47 • Number of events 9
Nervous system disorders Headache	14.9% 7/47 • Number of events 7
Investigations Hemoglobin	6.4% 3/47 • Number of events 3
Metabolism and nutrition disorders Hypercalcemia	6.4% 3/47 • Number of events 3
Metabolism and nutrition disorders Hyperglycemia	10.6% 5/47 • Number of events 5
Vascular disorders Hypertension	14.9% 7/47 • Number of events 7
Endocrine disorders Hypothyroidism	6.4% 3/47 • Number of events 3
Infections and infestations Infection (without neutropenia)	6.4% 3/47 • Number of events 3
Psychiatric disorders Insomnia	6.4% 3/47 • Number of events 3
Musculoskeletal and connective tissue disorders Joint, muscle or bone pain	6.4% 3/47 • Number of events 3
Psychiatric disorders Mood Changes - depression	6.4% 3/47 • Number of events 3
Psychiatric disorders Mood Changes-anxiety/agitation	23.4% 11/47 • Number of events 11
Gastrointestinal disorders Mucositis	10.6% 5/47 • Number of events 5
Musculoskeletal and connective tissue disorders Myalgia	6.4% 3/47 • Number of events 3
Gastrointestinal disorders Nausea	14.9% 7/47 • Number of events 7
General disorders Pain	40.4% 19/47 • Number of events 19
Skin and subcutaneous tissue disorders Pruritus	23.4% 11/47 • Number of events 11
Skin and subcutaneous tissue disorders Rash	61.7% 29/47 • Number of events 29
Investigations SGPT (ALT)	6.4% 3/47 • Number of events 3
Vascular disorders Hot flashes/flushes	14.9% 7/47 • Number of events 7
Investigations High cholesterol	10.6% 5/47 • Number of events 5
Respiratory, thoracic and mediastinal disorders Sinus infection	6.4% 3/47 • Number of events 3
Gastrointestinal disorders Vomiting	6.4% 3/47 • Number of events 3

Additional Information

Carlos Arteaga, M.D.

Vanderbilt-Ingram Cancer Center

Phone: (615) 936-1919

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place