A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting (NALA)
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ClinicalTrials.gov Identifier: NCT01808573 |
Recruitment Status :
Completed
First Posted : March 11, 2013
Results First Posted : December 11, 2019
Last Update Posted : June 11, 2021
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Sponsor:
Puma Biotechnology, Inc.
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
HER2+ Metastatic Breast Cancer (MBC) |
Interventions |
Drug: neratinib Drug: capecitabine Drug: lapatinib |
Enrollment | 621 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Neratinib Plus Capecitabine | Lapatinib Plus Capecitabine |
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Arm/Group Description | neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle. | lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle. |
Period Title: Overall Study | ||
Started | 307 | 314 |
Received Treatment | 303 | 311 |
Completed | 0 | 0 |
Not Completed | 307 | 314 |
Reason Not Completed | ||
Death | 212 | 240 |
Withdrawal by Subject | 12 | 10 |
Lost to Follow-up | 3 | 0 |
Discontinuation of study by sponsor | 79 | 64 |
Randomized in Error | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Neratinib Plus Capecitabine | Lapatinib Plus Capecitabine | Total | |
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Arm/Group Description | neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle. | lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle. | Total of all reporting groups | |
Overall Number of Baseline Participants | 307 | 314 | 621 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 307 participants | 314 participants | 621 participants | |
55.04 (11.37) | 54.32 (11.36) | 54.67 (11.36) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 307 participants | 314 participants | 621 participants | |
Female |
307 100.0%
|
311 99.0%
|
618 99.5%
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Male |
0 0.0%
|
3 1.0%
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3 0.5%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 307 participants | 314 participants | 621 participants | |
Hispanic or Latino |
40 13.0%
|
42 13.4%
|
82 13.2%
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Not Hispanic or Latino |
256 83.4%
|
259 82.5%
|
515 82.9%
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Unknown or Not Reported |
11 3.6%
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13 4.1%
|
24 3.9%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Race | Number Analyzed | 307 participants | 314 participants | 621 participants |
Asian |
109 35.5%
|
105 33.4%
|
214 34.5%
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Black or African American |
9 2.9%
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15 4.8%
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24 3.9%
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|
Native Hawaiian or Other Pacific Islander |
1 0.3%
|
1 0.3%
|
2 0.3%
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White |
178 58.0%
|
177 56.4%
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355 57.2%
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Other |
7 2.3%
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10 3.2%
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17 2.7%
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Unknown/Missing |
3 1.0%
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6 1.9%
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9 1.4%
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Previous HER2 Regimens
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 307 participants | 314 participants | 621 participants | |
2 |
215 70.0%
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215 68.5%
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430 69.2%
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>=3 |
92 30.0%
|
99 31.5%
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191 30.8%
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Disease Location
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 307 participants | 314 participants | 621 participants | |
Non Visceral |
60 19.5%
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61 19.4%
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121 19.5%
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Visceral |
247 80.5%
|
253 80.6%
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500 80.5%
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Hormone Receptor Status
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 307 participants | 314 participants | 621 participants | |
Negative |
126 41.0%
|
128 40.8%
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254 40.9%
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Positive |
181 59.0%
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186 59.2%
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367 59.1%
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Geographic Region
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 307 participants | 314 participants | 621 participants | |
Europe |
121 39.4%
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123 39.2%
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244 39.3%
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North America |
59 19.2%
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65 20.7%
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124 20.0%
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Rest of World |
127 41.4%
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126 40.1%
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253 40.7%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Senior Director, Clinical Operations |
Organization: | Puma Biotechnology, Inc. |
Phone: | 424-248-6500 |
EMail: | clinicaltrials@pumabiotechnology.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Puma Biotechnology, Inc. |
ClinicalTrials.gov Identifier: | NCT01808573 |
Other Study ID Numbers: |
PUMA-NER-1301 2012-004492-38 ( EudraCT Number ) UTN U1111-1161-1603 ( Other Identifier: WHO ) |
First Submitted: | March 4, 2013 |
First Posted: | March 11, 2013 |
Results First Submitted: | September 27, 2019 |
Results First Posted: | December 11, 2019 |
Last Update Posted: | June 11, 2021 |