Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
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ClinicalTrials.gov Identifier: NCT00770809 |
Recruitment Status :
Active, not recruiting
First Posted : October 10, 2008
Results First Posted : May 27, 2015
Last Update Posted : May 16, 2024
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
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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 |
Conditions |
Male Breast Carcinoma Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 |
Interventions |
Other: Laboratory Biomarker Analysis Drug: Lapatinib Ditosylate Drug: Paclitaxel Biological: Trastuzumab |
Enrollment | 305 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Arm I (THL) | Arm II (TH) | Arm III (TL) |
---|---|---|---|
Arm/Group Description | Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. | Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity. | Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11) |
Period Title: Overall Study | |||
Started | 118 | 120 | 67 |
Completed | 101 | 110 | 44 |
Not Completed | 17 | 10 | 23 |
Reason Not Completed | |||
Adverse Event | 9 | 1 | 12 |
Death | 1 | 0 | 0 |
Withdrawal by Subject | 3 | 3 | 7 |
Progression | 2 | 2 | 0 |
Complicating illness | 0 | 0 | 1 |
Other Medical Reasons | 2 | 4 | 3 |
Baseline Characteristics
Arm/Group Title | Arm I (THL) | Arm II (TH) | Arm III (TL) | Total | |
---|---|---|---|---|---|
Arm/Group Description | Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. | Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity. | Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11) | Total of all reporting groups | |
Overall Number of Baseline Participants | 118 | 120 | 67 | 305 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 118 participants | 120 participants | 67 participants | 305 participants | |
48.5
(24.7 to 70.8)
|
50.3
(30.2 to 75.8)
|
48.3
(25.8 to 74.3)
|
49.4
(24.7 to 75.8)
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 118 participants | 120 participants | 67 participants | 305 participants | |
Female |
117 99.2%
|
119 99.2%
|
67 100.0%
|
303 99.3%
|
|
Male |
1 0.8%
|
1 0.8%
|
0 0.0%
|
2 0.7%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 118 participants | 120 participants | 67 participants | 305 participants | |
American Indian or Alaska Native |
1 0.8%
|
1 0.8%
|
0 0.0%
|
2 0.7%
|
|
Asian |
4 3.4%
|
8 6.7%
|
5 7.5%
|
17 5.6%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
1 0.8%
|
0 0.0%
|
1 0.3%
|
|
Black or African American |
12 10.2%
|
8 6.7%
|
7 10.4%
|
27 8.9%
|
|
White |
95 80.5%
|
97 80.8%
|
51 76.1%
|
243 79.7%
|
|
More than one race |
2 1.7%
|
0 0.0%
|
0 0.0%
|
2 0.7%
|
|
Unknown or Not Reported |
4 3.4%
|
5 4.2%
|
4 6.0%
|
13 4.3%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 118 participants | 120 participants | 67 participants | 305 participants |
118 | 120 | 67 | 305 | ||
Clinical Stage
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 118 participants | 120 participants | 67 participants | 305 participants |
Stage II | 81 | 80 | 48 | 209 | |
Stage III | 37 | 40 | 19 | 96 | |
[1]
Measure Description: The American Joint Committee on Cancer (AJCC) has designated staging by tumor, node, and metastasis (TNM) classification. Stage II participants had primary tumors 0-5 cm and no regional lymph node metastases or metastases to movable ipsilateral level I, II axillary lymph node or primary tumors > 5.1 cm and no regional lymph node metastases. Stage III participants had primary tumors of any size but not any metastases in ipsilateral infraclavicular (level III axillary) lymph node(s) with or without level I, II axillary lymph node involvement
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Hormone Receptor Status
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 118 participants | 120 participants | 67 participants | 305 participants |
ER/PgR Positive | 70 | 70 | 39 | 179 | |
ER/PgR or Negative | 48 | 50 | 28 | 126 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Lisa Carey, M.D. |
Organization: | University of North Carolina - Lineberger Comprehensive Cancer Center |
EMail: | lisa_carey@med.unc.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00770809 |
Other Study ID Numbers: |
NCI-2009-01073 NCI-2009-01073 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000616648 CALGB 40601 ( Other Identifier: Alliance for Clinical Trials in Oncology ) CALGB-40601 ( Other Identifier: CTEP ) U10CA180821 ( U.S. NIH Grant/Contract ) U10CA031946 ( U.S. NIH Grant/Contract ) |
First Submitted: | October 9, 2008 |
First Posted: | October 10, 2008 |
Results First Submitted: | May 7, 2015 |
Results First Posted: | May 27, 2015 |
Last Update Posted: | May 16, 2024 |