Trial Outcomes & Findings for Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer. (NCT NCT00611715)
NCT ID: NCT00611715
Last Updated: 2012-08-09
Results Overview
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
TERMINATED
PHASE2
48 participants
at 24 weeks
2012-08-09
Participant Flow
This study enrolled patients from November 2003 through July 2008.
Fifty-one patients consented, one was ineligible and two withdrew before receiving study drug.
Participant milestones
| Measure |
First Line/Hormone-therapy Naive
Patients who have not received hormonal therapy
|
Second-line/Prev Hormone-therapy tx
Patients who have previously received hormonal therapy
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
6
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
6
|
Reasons for withdrawal
| Measure |
First Line/Hormone-therapy Naive
Patients who have not received hormonal therapy
|
Second-line/Prev Hormone-therapy tx
Patients who have previously received hormonal therapy
|
|---|---|---|
|
Overall Study
Disease Progression
|
24
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Adverse Event
|
9
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
two patients are still on treatment
|
2
|
0
|
Baseline Characteristics
Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer.
Baseline characteristics by cohort
| Measure |
First Line/Hormone-therapy Naive
n=42 Participants
Patients who have not received hormonal therapy
|
Second-line/Prev Hormone-therapy tx
n=6 Participants
Patients who have previously received hormonal therapy
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age Continuous
|
62 years
STANDARD_DEVIATION 1 • n=5 Participants
|
54 years
STANDARD_DEVIATION 1 • n=7 Participants
|
61 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
6 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 24 weeksPopulation: Analysis population is patients who were available for response measurement. Some patients did not meet the criteria to be analyzed for response evaluation which accounts for the discrepancy in patients analyzed vs. total accrual population.
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
Outcome measures
| Measure |
Hormone Therapy Naive
n=35 Participants
Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
|
Previous Hormone Therapy
n=5 Participants
Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
|
|---|---|---|
|
Number of Patients With Pathological Complete Response.
|
28 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Every 12 weeks from on-study to disease progressionPopulation: Patients who were available for response measurement. Seven patients in the Hormone therapy naive arm did not meet the criteria for response evaluation. One patient in the Previous Hormone Therapy arm did not meet the criteria for response evaluation.
Time frame from study entry till discontinuation of treatment due to disease progression. Progression of target lesions is measured by RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.
Outcome measures
| Measure |
Hormone Therapy Naive
n=35 Participants
Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
|
Previous Hormone Therapy
n=5 Participants
Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
|
|---|---|---|
|
Median Time to Progression of Target Lesions
|
12 Months
Full Range 11.5 • Interval 1.0 to 75.0
|
3 Months
Full Range 0 • Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: at 24 weeksPopulation: Analysis population is patients who were available for response measurement. Seven patients in the Hormone therapy naive arm did not meet the criteria for response evaluation. One patient in the Previous Hormone Therapy arm did not meet the criteria for response evaluation.
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions and partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions.
Outcome measures
| Measure |
Hormone Therapy Naive
n=35 Participants
Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
|
Previous Hormone Therapy
n=5 Participants
Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
|
|---|---|---|
|
Number of Patients With Anti-tumor Activity: Complete Response (CR) and Partial Response (PR)
|
8 participants
|
0 participants
|
SECONDARY outcome
Timeframe: at 24 weeksPopulation: All patients who received treatment and experienced an adverse event.
Number of patients with worst-grade toxicities following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death
Outcome measures
| Measure |
Hormone Therapy Naive
n=42 Participants
Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
|
Previous Hormone Therapy
n=6 Participants
Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
|
|---|---|---|
|
Number of Patients With Worst-grade Toxicities Per Grade
Worst grade toxicity Grade 1
|
11 participants
|
0 participants
|
|
Number of Patients With Worst-grade Toxicities Per Grade
Worst grade toxicity Grade 2
|
21 participants
|
3 participants
|
|
Number of Patients With Worst-grade Toxicities Per Grade
Worst grade toxicity Grade 3
|
8 participants
|
2 participants
|
|
Number of Patients With Worst-grade Toxicities Per Grade
Worst grade toxicity Grade 4
|
1 participants
|
0 participants
|
|
Number of Patients With Worst-grade Toxicities Per Grade
Worst grade toxicity Grade 5
|
0 participants
|
0 participants
|
Adverse Events
First Line/Hormone-therapy Naive
Second-line/Prev Hormone-therapy tx
Serious adverse events
| Measure |
First Line/Hormone-therapy Naive
n=42 participants at risk
Patients who have not received hormonal therapy
|
Second-line/Prev Hormone-therapy tx
n=6 participants at risk
Patients who have previously received hormonal therapy
|
|---|---|---|
|
Infections and infestations
catheter-related infection
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Renal and urinary disorders
renal failure
|
7.1%
3/42 • Number of events 4
|
0.00%
0/6
|
|
Investigations
creatinine
|
4.8%
2/42 • Number of events 3
|
0.00%
0/6
|
|
Infections and infestations
cellulitis, breast
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
hypertension
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
cebebrovascular ischema
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
infection without neutropenia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
acidosis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Investigations
alkaline phosphate
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Investigations
bilirubin
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Investigations
transaminases elevation
|
4.8%
2/42 • Number of events 4
|
0.00%
0/6
|
|
Gastrointestinal disorders
diarrhea
|
4.8%
2/42 • Number of events 4
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
thrombosis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
infection - urinary
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
neuropathy
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Cardiac disorders
pericardial effusion
|
2.4%
1/42 • Number of events 2
|
0.00%
0/6
|
|
Vascular disorders
hypotension
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
General disorders
death
|
4.8%
2/42 • Number of events 2
|
0.00%
0/6
|
|
Cardiac disorders
arrhythmia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
dehydration
|
4.8%
2/42 • Number of events 2
|
0.00%
0/6
|
|
Investigations
platelets
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
General disorders
edema
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
General disorders
pain, breast
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
rash
|
4.8%
2/42 • Number of events 8
|
0.00%
0/6
|
|
Vascular disorders
hot flash
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
anorexia
|
4.8%
2/42 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
nausea
|
7.1%
3/42 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
headache
|
7.1%
3/42 • Number of events 3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hyperkalemia
|
4.8%
2/42 • Number of events 2
|
0.00%
0/6
|
|
General disorders
fatigue
|
2.4%
1/42 • Number of events 2
|
0.00%
0/6
|
|
Psychiatric disorders
confusion
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
sinus tachycardia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hypokalemia
|
2.4%
1/42 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
vomiting
|
2.4%
1/42 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood urea nitrogen (BUN)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
|
General disorders
fever
|
2.4%
1/42 • Number of events 1
|
16.7%
1/6 • Number of events 5
|
|
Infections and infestations
keratitis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/6
|
Other adverse events
| Measure |
First Line/Hormone-therapy Naive
n=42 participants at risk
Patients who have not received hormonal therapy
|
Second-line/Prev Hormone-therapy tx
n=6 participants at risk
Patients who have previously received hormonal therapy
|
|---|---|---|
|
Investigations
hemoglobin increased
|
4.8%
2/42 • Number of events 7
|
0.00%
0/6
|
|
Gastrointestinal disorders
diarrhea
|
4.8%
2/42 • Number of events 3
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
skin rash
|
4.8%
2/42 • Number of events 8
|
0.00%
0/6
|
|
Psychiatric disorders
insomnia
|
4.8%
2/42 • Number of events 2
|
0.00%
0/6
|
|
Vascular disorders
hypertension
|
4.8%
2/42 • Number of events 2
|
0.00%
0/6
|
|
Nervous system disorders
neuropathy
|
4.8%
2/42 • Number of events 2
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place