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Trial record 1 of 31 for:    ABP-980
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Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer (Lilac)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01901146
Recruitment Status : Completed
First Posted : July 17, 2013
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Actavis Inc.
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: ABP 980
Drug: Trastuzumab
Drug: Paclitaxel
Procedure: Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection
Enrollment 725
Recruitment Details This study was conducted at 123 sites in 20 countries from April 2013 to January 2017. The study consisted of a neoadjuvant treatment phase for 4 cycles, surgery, and adjuvant treatment for up to one year from the first day of study drug administration in the neoadjuvant phase.
Pre-assignment Details Enrolled patients received run-in chemotherapy consisting of epirubicin and cyclophosphamide every 3 weeks for 4 cycles. After the run-in, participants with adequate cardiac function were randomized. Randomization was stratified by tumor stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.
Arm/Group Title ABP 980 Trastuzumab ABP 980/ABP 980 Trastuzumab/Trastuzumab Trastuzumab/ABP 980
Hide Arm/Group Description Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles. Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles. After surgery, participants initially randomized to ABP 980 continued to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase. After surgery, participants originally randomized to trastuzumab were re-randomized and continued to receive trastuzumab at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase. After surgery, participants originally randomized to trastuzumab were re-randomized and switched to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
Period Title: Neoadjuvant Phase
Started 364 361 0 0 0
Completed 358 [1] 347 [1] 0 0 0
Not Completed 6 14 0 0 0
Reason Not Completed
Death             1             2             0             0             0
Disease Progression or Recurrence             2             3             0             0             0
Lost to Follow-up             0             1             0             0             0
Physician Decision             1             2             0             0             0
Withdrawal by Subject             2             5             0             0             0
Requirement for Alternative Therapy             0             1             0             0             0
[1]
Indicates participants who completed surgery
Period Title: Adjuvant Phase
Started 0 0 349 [1] 171 [2] 171 [3]
Completed 0 0 323 164 157
Not Completed 0 0 26 7 14
Reason Not Completed
Other             0             0             1             0             0
Death             0             0             0             0             3
Disease Progression or Recurrence             0             0             12             4             3
Physician Decision             0             0             9             2             4
Withdrawal by Subject             0             0             4             1             4
[1]
Nine participants discontinued the study after surgery but before entering adjuvant phase.
[2]
Two participants discontinued the study after surgery but before entering adjuvant phase.
[3]
Three participants discontinued the study after surgery but before entering adjuvant phase.
Arm/Group Title ABP 980 Trastuzumab Total
Hide Arm/Group Description Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles. Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles. Total of all reporting groups
Overall Number of Baseline Participants 364 361 725
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 364 participants 361 participants 725 participants
52.8  (10.72) 52.7  (11.29) 52.7  (11.00)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 361 participants 725 participants
< 50 years
140
  38.5%
134
  37.1%
274
  37.8%
≥ 50 years
224
  61.5%
227
  62.9%
451
  62.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 361 participants 725 participants
Female
364
 100.0%
361
 100.0%
725
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 361 participants 725 participants
White
331
  90.9%
333
  92.2%
664
  91.6%
Black or African American
10
   2.7%
4
   1.1%
14
   1.9%
Asian
2
   0.5%
3
   0.8%
5
   0.7%
American Indian or Alaska Native
1
   0.3%
0
   0.0%
1
   0.1%
Native Hawaiian or other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Other
20
   5.5%
21
   5.8%
41
   5.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 361 participants 725 participants
Hispanic or Latino
32
   8.8%
36
  10.0%
68
   9.4%
Not Hispanic or Latino
332
  91.2%
324
  89.8%
656
  90.5%
Not allowed to collect
0
   0.0%
1
   0.3%
1
   0.1%
Tumor Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 361 participants 725 participants
< T4
282
  77.5%
281
  77.8%
563
  77.7%
T4
82
  22.5%
80
  22.2%
162
  22.3%
[1]
Measure Description: In the Tumor Node Metastasis (TNM) staging system, a "T" followed by a number shows the size of the tumor. Less than T4 indicates a tumor that is 5 cm or less. T4 indicates the tumor is any size, but has spread beyond the breast tissue to the chest wall and/or skin.
Axilla Lymph Node Involvement  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 361 participants 725 participants
Yes
277
  76.1%
266
  73.7%
543
  74.9%
No
87
  23.9%
95
  26.3%
182
  25.1%
Hormone Receptor Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 361 participants 725 participants
Estrogen and/or progesterone receptor positive
265
  72.8%
268
  74.2%
533
  73.5%
Estrogen and progesterone receptor negative
99
  27.2%
93
  25.8%
192
  26.5%
Paclitaxel Dosing Schedule  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 361 participants 725 participants
Every 3 weeks
256
  70.3%
258
  71.5%
514
  70.9%
Every week
108
  29.7%
103
  28.5%
211
  29.1%
Geographic Region  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 361 participants 725 participants
Eastern Europe
271
  74.5%
273
  75.6%
544
  75.0%
Western Europe
43
  11.8%
46
  12.7%
89
  12.3%
Other
50
  13.7%
42
  11.6%
92
  12.7%
1.Primary Outcome
Title Percentage of Participants With a Pathologic Complete Response
Hide Description

Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue and in axillary lymph nodes, regardless of residual ductal carcinoma in situ (DCIS).

Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.

Time Frame 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase
Hide Outcome Measure Data
Hide Analysis Population Description
The pCR evaluable population, which included all randomized participants who received any amount of study drug, underwent the surgery, and had a non-missing evaluable pCR assessment from the local laboratory evaluation.
Arm/Group Title ABP 980 Trastuzumab
Hide Arm/Group Description:
Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
Overall Number of Participants Analyzed 358 338
Measure Type: Number
Unit of Measure: percentage of participants
48.0 40.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 980, Trastuzumab
Comments The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% confidence interval (CI) of the Risk Difference (RD; ABP 980 - Trastuzumab) of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%), estimated using a generalized linear model adjusted for stratification factors tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.
Type of Statistical Test Equivalence
Comments The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% CI of the risk difference of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%).
Statistical Test of Hypothesis P-Value 0.0508
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model adjusted for the randomization stratification factors.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 7.3
Confidence Interval (2-Sided) 90%
1.2 to 13.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 980, Trastuzumab
Comments If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the Risk Ratio (RR; ABP 980 / Trastuzumab) of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab, estimated using a generalized linear model adjusted for stratification factors: tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.
Type of Statistical Test Equivalence
Comments If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the risk ratio of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab estimated using a generalized linear model adjusted for stratification factors, with the margin of (0.7586, 1/0.7586). If the test of equivalence on the RD was not successful, the RR of pCR and 90% CI were considered to be descriptive.
Statistical Test of Hypothesis P-Value 0.0430
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model adjusted for the randomization stratification factors.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.1877
Confidence Interval (2-Sided) 90%
1.0327 to 1.3660
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With a Pathologic Complete Response in Breast Tissue Only
Hide Description

Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue, regardless of residual ductal carcinoma in situ (DCIS).

Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.

Time Frame 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase
Hide Outcome Measure Data
Hide Analysis Population Description
pCR evaluable population
Arm/Group Title ABP 980 Trastuzumab
Hide Arm/Group Description:
Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
Overall Number of Participants Analyzed 358 338
Measure Type: Number
Unit of Measure: percentage of participants
51.1 45.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 980, Trastuzumab
Comments The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.
Type of Statistical Test Other
Comments Analyses of secondary endpoints were prespecified to be considered descriptive only.
Statistical Test of Hypothesis P-Value 0.1086
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model adjusted for the randomization stratification factors.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 6.0
Confidence Interval (2-Sided) 90%
-0.2 to 12.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 980, Trastuzumab
Comments The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.
Type of Statistical Test Other
Comments Analyses of secondary endpoints were prespecified to be considered descriptive only.
Statistical Test of Hypothesis P-Value 0.0807
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model adjusted for the randomization stratification factors.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.1463
Confidence Interval (2-Sided) 90%
1.0080 to 1.3035
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With a Pathologic Complete Response in Breast Tissue and Axillary Lymph Nodes and Absence of DCIS
Hide Description

Pathological complete response was defined as the absence of invasive tumor cells in the breast tissue and axillary lymph node(s) and absence of residual DCIS.

Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.

Time Frame 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase
Hide Outcome Measure Data
Hide Analysis Population Description
pCR evaluable population
Arm/Group Title ABP 980 Trastuzumab
Hide Arm/Group Description:
Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
Overall Number of Participants Analyzed 358 338
Measure Type: Number
Unit of Measure: percentage of participants
37.7 29.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 980, Trastuzumab
Comments The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.
Type of Statistical Test Other
Comments Analyses of secondary endpoints were prespecified to be considered descriptive only.
Statistical Test of Hypothesis P-Value 0.0253
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model adjusted for the randomization stratification factors.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.0
Confidence Interval (2-Sided) 90%
2.1 to 13.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 980, Trastuzumab
Comments The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.
Type of Statistical Test Other
Comments Analyses of secondary endpoints were prespecified to be considered descriptive only.
Statistical Test of Hypothesis P-Value 0.0245
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model adjusted for the randomization stratification factors.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.2746
Confidence Interval (2-Sided) 90%
1.0673 to 1.5222
Estimation Comments [Not Specified]
Time Frame Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Neoadjuvant Phase: ABP 980 Neoadjuvant Phase: Trastuzumab Adjuvant Phase: ABP 980/ABP 980 Adjuvant Phase: Trastuzumab/Trastuzumab Adjuvant Phase: Trastuzumab/ABP 980
Hide Arm/Group Description Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles. Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles. After surgery, participants initially randomized to ABP 980 continued to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase. After surgery, participants originally randomized to trastuzumab were re-randomized and continued to receive trastuzumab at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase. After surgery, participants originally randomized to trastuzumab were re-randomized and switched to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
All-Cause Mortality
Neoadjuvant Phase: ABP 980 Neoadjuvant Phase: Trastuzumab Adjuvant Phase: ABP 980/ABP 980 Adjuvant Phase: Trastuzumab/Trastuzumab Adjuvant Phase: Trastuzumab/ABP 980
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Neoadjuvant Phase: ABP 980 Neoadjuvant Phase: Trastuzumab Adjuvant Phase: ABP 980/ABP 980 Adjuvant Phase: Trastuzumab/Trastuzumab Adjuvant Phase: Trastuzumab/ABP 980
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/364 (4.95%)   5/361 (1.39%)   18/349 (5.16%)   6/171 (3.51%)   6/171 (3.51%) 
Blood and lymphatic system disorders           
Febrile neutropenia  1  3/364 (0.82%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Cardiac disorders           
Atrial fibrillation  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Cardio-respiratory arrest  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Sinus bradycardia  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Ventricular extrasystoles  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  1/171 (0.58%) 
Gastrointestinal disorders           
Enterocolitis  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Faecaloma  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Gastric ulcer perforation  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Gastrointestinal toxicity  1  0/364 (0.00%)  1/361 (0.28%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Pancreatitis acute  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
General disorders           
Asthenia  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Chest pain  1  1/364 (0.27%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Gait disturbance  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Immune system disorders           
Hypersensitivity  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Infections and infestations           
Cystitis  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Incision site infection  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Pneumocystis jirovecii pneumonia  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  1/171 (0.58%) 
Pneumonia  1  2/364 (0.55%)  0/361 (0.00%)  0/349 (0.00%)  2/171 (1.17%)  0/171 (0.00%) 
Pneumonia bacterial  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Sepsis  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Septic shock  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  1/171 (0.58%) 
Soft tissue infection  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  1/171 (0.58%)  0/171 (0.00%) 
Urinary tract infection  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Wound sepsis  1  0/364 (0.00%)  1/361 (0.28%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Injury, poisoning and procedural complications           
Drug dispensing error  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Humerus fracture  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Ligament sprain  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Radiation pneumonitis  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  1/171 (0.58%)  1/171 (0.58%) 
Radius fracture  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Subcutaneous haematoma  1  0/364 (0.00%)  1/361 (0.28%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Tibia fracture  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Upper limb fracture  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  1/171 (0.58%) 
Wound  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Wound decomposition  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  0/364 (0.00%)  1/361 (0.28%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Aspartate aminotransferase increased  1  0/364 (0.00%)  1/361 (0.28%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
White blood cell count decreased  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Breast cancer  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  1/171 (0.58%) 
Metastases to adrenals  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  1/171 (0.58%) 
Metastases to bone  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  1/171 (0.58%) 
Metastases to central nervous system  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Metastases to liver  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  1/171 (0.58%) 
Metastases to lung  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  1/171 (0.58%) 
Nervous system disorders           
Autonomic nervous system imbalance  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Headache  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Ischaemic stroke  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Psychiatric disorders           
Anxiety disorder  1  0/364 (0.00%)  1/361 (0.28%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Bipolar disorder  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  1/171 (0.58%)  0/171 (0.00%) 
Renal and urinary disorders           
Acute prerenal failure  1  0/364 (0.00%)  1/361 (0.28%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Reproductive system and breast disorders           
Breast haematoma  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Postmenopausal haemorrhage  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  1/171 (0.58%)  0/171 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Hydrothorax  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  1/171 (0.58%)  0/171 (0.00%) 
Pneumothorax  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  1/171 (0.58%)  0/171 (0.00%) 
Respiratory failure  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  1/171 (0.58%) 
Surgical and medical procedures           
Hysterectomy  1  0/364 (0.00%)  0/361 (0.00%)  1/349 (0.29%)  0/171 (0.00%)  0/171 (0.00%) 
Vascular disorders           
Deep vein thrombosis  1  0/364 (0.00%)  0/361 (0.00%)  0/349 (0.00%)  1/171 (0.58%)  0/171 (0.00%) 
Vena cava thrombosis  1  1/364 (0.27%)  0/361 (0.00%)  0/349 (0.00%)  0/171 (0.00%)  0/171 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Neoadjuvant Phase: ABP 980 Neoadjuvant Phase: Trastuzumab Adjuvant Phase: ABP 980/ABP 980 Adjuvant Phase: Trastuzumab/Trastuzumab Adjuvant Phase: Trastuzumab/ABP 980
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   227/364 (62.36%)   220/361 (60.94%)   124/349 (35.53%)   49/171 (28.65%)   60/171 (35.09%) 
Blood and lymphatic system disorders           
Anaemia  1  40/364 (10.99%)  38/361 (10.53%)  17/349 (4.87%)  7/171 (4.09%)  10/171 (5.85%) 
Leukopenia  1  21/364 (5.77%)  16/361 (4.43%)  15/349 (4.30%)  5/171 (2.92%)  8/171 (4.68%) 
Neutropenia  1  53/364 (14.56%)  45/361 (12.47%)  25/349 (7.16%)  10/171 (5.85%)  6/171 (3.51%) 
Gastrointestinal disorders           
Diarrhoea  1  23/364 (6.32%)  19/361 (5.26%)  9/349 (2.58%)  2/171 (1.17%)  4/171 (2.34%) 
Nausea  1  21/364 (5.77%)  18/361 (4.99%)  11/349 (3.15%)  3/171 (1.75%)  2/171 (1.17%) 
General disorders           
Asthenia  1  54/364 (14.84%)  59/361 (16.34%)  17/349 (4.87%)  7/171 (4.09%)  10/171 (5.85%) 
Injury, poisoning and procedural complications           
Radiation skin injury  1  0/364 (0.00%)  0/361 (0.00%)  37/349 (10.60%)  17/171 (9.94%)  16/171 (9.36%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  63/364 (17.31%)  55/361 (15.24%)  20/349 (5.73%)  9/171 (5.26%)  9/171 (5.26%) 
Bone pain  1  12/364 (3.30%)  29/361 (8.03%)  1/349 (0.29%)  0/171 (0.00%)  3/171 (1.75%) 
Myalgia  1  34/364 (9.34%)  31/361 (8.59%)  2/349 (0.57%)  3/171 (1.75%)  2/171 (1.17%) 
Nervous system disorders           
Neuropathy peripheral  1  51/364 (14.01%)  43/361 (11.91%)  8/349 (2.29%)  3/171 (1.75%)  2/171 (1.17%) 
Paraesthesia  1  17/364 (4.67%)  21/361 (5.82%)  6/349 (1.72%)  0/171 (0.00%)  1/171 (0.58%) 
Peripheral sensory neuropathy  1  25/364 (6.87%)  22/361 (6.09%)  3/349 (0.86%)  0/171 (0.00%)  0/171 (0.00%) 
Skin and subcutaneous tissue disorders           
Alopecia  1  19/364 (5.22%)  23/361 (6.37%)  3/349 (0.86%)  0/171 (0.00%)  2/171 (1.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01901146    
Other Study ID Numbers: 20120283
2012-004319-29 ( EudraCT Number )
First Submitted: May 20, 2013
First Posted: July 17, 2013
Results First Submitted: June 18, 2019
Results First Posted: August 7, 2019
Last Update Posted: August 7, 2019