Trial Outcomes & Findings for Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer (NCT NCT02162667)
NCT ID: NCT02162667
Last Updated: 2022-08-03
Results Overview
Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period. The primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
562 participants
Primary outcome timeframe
After Neo-adjuvant therapy and Surgery (up to 30 weeks)
Results posted on
2022-08-03
Participant Flow
Participant milestones
| Measure |
CT-P6
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery)
|
Herceptin
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).
|
|---|---|---|
|
Neoadjuvant Period
STARTED
|
278
|
284
|
|
Neoadjuvant Period
COMPLETED
|
264
|
267
|
|
Neoadjuvant Period
NOT COMPLETED
|
14
|
17
|
|
Adjuvant Period
STARTED
|
260
|
268
|
|
Adjuvant Period
COMPLETED
|
248
|
255
|
|
Adjuvant Period
NOT COMPLETED
|
12
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
Baseline characteristics by cohort
| Measure |
CT-P6
n=278 Participants
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).
|
Herceptin
n=284 Participants
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).
|
Total
n=562 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.0 years
n=5 Participants
|
52.5 years
n=7 Participants
|
53.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
278 Participants
n=5 Participants
|
284 Participants
n=7 Participants
|
562 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After Neo-adjuvant therapy and Surgery (up to 30 weeks)Population: Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.
Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period. The primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.
Outcome measures
| Measure |
CT-P6
n=248 Participants
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
Herceptin
n=256 Participants
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
|---|---|---|
|
The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)
|
46.77 percentage of responders
Interval 40.43 to 53.19
|
50.39 percentage of responders
Interval 44.1 to 56.68
|
SECONDARY outcome
Timeframe: After Neo-adjuvant therapy and Surgery (up to 30 weeks)Population: Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.
Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period. The secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.
Outcome measures
| Measure |
CT-P6
n=248 Participants
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
Herceptin
n=256 Participants
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
|---|---|---|
|
The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status
|
4.84 percentage of responders
Interval 2.52 to 8.3
|
4.69 percentage of responders
Interval 2.45 to 8.04
|
SECONDARY outcome
Timeframe: After Neo-adjuvant therapy and Surgery (up to 30 weeks)Population: Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.
Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period. The secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.
Outcome measures
| Measure |
CT-P6
n=248 Participants
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
Herceptin
n=256 Participants
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
|---|---|---|
|
The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS
|
39.92 percentage of responders
Interval 33.78 to 46.31
|
41.41 percentage of responders
Interval 35.31 to 47.71
|
SECONDARY outcome
Timeframe: After Neo-adjuvant therapy (up to 24 weeks)Population: Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.
The ORR was defined as the proportion of patients with a BOR of CR or PR as assessed by RECIST guideline Version 1.1 during the Nedadjuvant Period.
Outcome measures
| Measure |
CT-P6
n=248 Participants
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
Herceptin
n=256 Participants
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
|---|---|---|
|
Overall Response Rate (ORR) From Local Review
|
84.27 percentage of responders
Interval 79.14 to 88.57
|
83.98 percentage of responders
Interval 78.91 to 88.26
|
SECONDARY outcome
Timeframe: Up to 3 years from the day of last patient enrollment (during whole study period)Population: Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.
Patients who underwent breast surgery were included in the DFS analysis. Disease-free survival was defined as the interval between the date of breast surgery and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.
Outcome measures
| Measure |
CT-P6
n=248 Participants
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
Herceptin
n=256 Participants
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
|---|---|---|
|
Disease-free Survival
1 year
|
0.95 proportion of participants
Interval 0.91 to 0.97
|
0.96 proportion of participants
Interval 0.93 to 0.98
|
|
Disease-free Survival
2 years
|
0.87 proportion of participants
Interval 0.81 to 0.9
|
0.89 proportion of participants
Interval 0.85 to 0.92
|
|
Disease-free Survival
3 years
|
0.82 proportion of participants
Interval 0.77 to 0.87
|
0.82 proportion of participants
Interval 0.75 to 0.88
|
SECONDARY outcome
Timeframe: Up to 3 years from the day of last patient enrollment (during whole study period)Population: Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.
Progression-free survival was defined as the interval between randomization and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.
Outcome measures
| Measure |
CT-P6
n=248 Participants
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
Herceptin
n=256 Participants
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
|---|---|---|
|
Progression-Free Survival
1 year
|
0.99 proportion of participants
Interval 0.97 to 1.0
|
0.98 proportion of participants
Interval 0.95 to 0.99
|
|
Progression-Free Survival
2 years
|
0.90 proportion of participants
Interval 0.86 to 0.94
|
0.93 proportion of participants
Interval 0.89 to 0.95
|
|
Progression-Free Survival
3 years
|
0.82 proportion of participants
Interval 0.77 to 0.87
|
0.87 proportion of participants
Interval 0.82 to 0.9
|
SECONDARY outcome
Timeframe: Up to 3 years from the day of last patient enrollment (during whole study period)Population: Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.
Overall survival was defined as the interval between randomization and death from any cause.
Outcome measures
| Measure |
CT-P6
n=248 Participants
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
Herceptin
n=256 Participants
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
|---|---|---|
|
Overall Survival
1 year
|
1.00 proportion of participants
Interval 1.0 to 1.0
|
1.00 proportion of participants
Interval 0.97 to 1.0
|
|
Overall Survival
2 years
|
0.98 proportion of participants
Interval 0.95 to 0.99
|
0.98 proportion of participants
Interval 0.96 to 0.99
|
|
Overall Survival
3 years
|
0.95 proportion of participants
Interval 0.91 to 0.97
|
0.94 proportion of participants
Interval 0.9 to 0.96
|
SECONDARY outcome
Timeframe: Up to 3 years from the day of last patient enrollment (during whole study period)Population: Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.
If recurrence or progression of disease occurred at any time during the study, the progressed tumor site was recorded in the "recurrence or progression of disease" eCRF page as local, regional, or distant, with diagnostic method and whether positive cytology or histology or not. The resulting recurrence or progression of disease information was summarized as secondary endpoint.
Outcome measures
| Measure |
CT-P6
n=248 Participants
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
Herceptin
n=256 Participants
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
|---|---|---|
|
The Number of Patients Who Had Progressive Disease or Recurrence
Overall Period
|
41 participants
|
35 participants
|
|
The Number of Patients Who Had Progressive Disease or Recurrence
Neoadjuvant Period
|
1 participants
|
2 participants
|
|
The Number of Patients Who Had Progressive Disease or Recurrence
Adjuvant Period
|
5 participants
|
3 participants
|
|
The Number of Patients Who Had Progressive Disease or Recurrence
Follow-up Period
|
35 participants
|
30 participants
|
SECONDARY outcome
Timeframe: End of each treatment cycles, up to 24 weeks (during neoadjuvant period)Population: Safety Analysis Set: All patients randomly assigned to study drug and who receive at least 1 dose (fully or partially) of study drug
Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.
Outcome measures
| Measure |
CT-P6
n=271 Participants
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
Herceptin
n=278 Participants
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
|---|---|---|
|
Maximum Serum Concentration After Administration (Cmax) in Each Cycle
Cycle 7
|
146.726 µg/mL
Standard Deviation 48.0249
|
141.468 µg/mL
Standard Deviation 43.1823
|
|
Maximum Serum Concentration After Administration (Cmax) in Each Cycle
Cycle 1
|
186.428 µg/mL
Standard Deviation 69.0828
|
178.567 µg/mL
Standard Deviation 55.3800
|
|
Maximum Serum Concentration After Administration (Cmax) in Each Cycle
Cycle 2
|
145.078 µg/mL
Standard Deviation 47.7899
|
138.989 µg/mL
Standard Deviation 45.7103
|
|
Maximum Serum Concentration After Administration (Cmax) in Each Cycle
Cycle 3
|
145.183 µg/mL
Standard Deviation 44.5392
|
141.130 µg/mL
Standard Deviation 43.8189
|
|
Maximum Serum Concentration After Administration (Cmax) in Each Cycle
Cycle 4
|
148.541 µg/mL
Standard Deviation 54.2737
|
137.465 µg/mL
Standard Deviation 45.6914
|
|
Maximum Serum Concentration After Administration (Cmax) in Each Cycle
Cycle 5
|
136.210 µg/mL
Standard Deviation 44.6078
|
135.307 µg/mL
Standard Deviation 47.1950
|
|
Maximum Serum Concentration After Administration (Cmax) in Each Cycle
Cycle 6
|
143.569 µg/mL
Standard Deviation 42.4510
|
143.605 µg/mL
Standard Deviation 51.2868
|
|
Maximum Serum Concentration After Administration (Cmax) in Each Cycle
Cycle 8
|
145.081 µg/mL
Standard Deviation 41.5382
|
144.238 µg/mL
Standard Deviation 57.3618
|
SECONDARY outcome
Timeframe: Pre-infusion of cycles 1 to 8 during neoadjuvant periodPopulation: Safety Analysis Set: All patients randomly assigned to study drug and who receive at least 1 dose (fully or partially) of study drug
Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.
Outcome measures
| Measure |
CT-P6
n=271 Participants
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
Herceptin
n=278 Participants
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
|---|---|---|
|
Trough Serum Concentration (Ctrough) in Each Cycle
Cycle 5
|
18.403 µg/mL
Standard Deviation 19.9042
|
17.962 µg/mL
Standard Deviation 17.9429
|
|
Trough Serum Concentration (Ctrough) in Each Cycle
Cycle 6
|
18.902 µg/mL
Standard Deviation 20.2198
|
18.256 µg/mL
Standard Deviation 17.6964
|
|
Trough Serum Concentration (Ctrough) in Each Cycle
Cycle 1
|
18.915 µg/mL
Standard Deviation 22.9964
|
18.905 µg/mL
Standard Deviation 21.2967
|
|
Trough Serum Concentration (Ctrough) in Each Cycle
Cycle 2
|
17.346 µg/mL
Standard Deviation 17.9771
|
16.773 µg/mL
Standard Deviation 16.8134
|
|
Trough Serum Concentration (Ctrough) in Each Cycle
Cycle 3
|
16.796 µg/mL
Standard Deviation 17.2409
|
17.816 µg/mL
Standard Deviation 23.3438
|
|
Trough Serum Concentration (Ctrough) in Each Cycle
Cycle 4
|
17.851 µg/mL
Standard Deviation 20.1572
|
15.904 µg/mL
Standard Deviation 15.8754
|
|
Trough Serum Concentration (Ctrough) in Each Cycle
Cycle 7
|
18.540 µg/mL
Standard Deviation 14.3313
|
18.718 µg/mL
Standard Deviation 18.5976
|
|
Trough Serum Concentration (Ctrough) in Each Cycle
Cycle 8
|
17.901 µg/mL
Standard Deviation 7.2203
|
17.129 µg/mL
Standard Deviation 10.0491
|
POST_HOC outcome
Timeframe: After Neo-adjuvant therapy and Surgery (up to 30 weeks)Population: Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.
Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period. The secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.
Outcome measures
| Measure |
CT-P6
n=248 Participants
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
Herceptin
n=256 Participants
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
|
|---|---|---|
|
The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes Regardless of DCIS
|
51.61 percentage of responders
Interval 45.2 to 57.98
|
55.08 percentage of responders
Interval 48.76 to 61.28
|
Adverse Events
CT-P6
Serious events: 22 serious events
Other events: 263 other events
Deaths: 0 deaths
Herceptin
Serious events: 36 serious events
Other events: 264 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT-P6
n=271 participants at risk
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery)
|
Herceptin
n=278 participants at risk
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
1.1%
3/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
6/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
1.1%
3/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.74%
2/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
1.1%
3/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Gastrointestinal disorders
Stomatitis
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
General disorders
Implant site extravasation
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
General disorders
Incarcerated hernia
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
General disorders
Sudden death
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Immune system disorders
Drug hypersensitivity
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Infections and infestations
Appendicitis
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Infections and infestations
Bronchitis
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Infections and infestations
Device related infection
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.72%
2/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Infections and infestations
Endocarditis
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Infections and infestations
Pneumonia
|
0.74%
2/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Infections and infestations
Postoperative abscess
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Infections and infestations
Septic embolus
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Injury, poisoning and procedural complications
Complications of transplant surgery
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Investigations
Heart rate irregular
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.72%
2/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.37%
1/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.00%
0/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Surgical and medical procedures
Oocyte harvest
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
0.36%
1/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
Other adverse events
| Measure |
CT-P6
n=271 participants at risk
Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery)
|
Herceptin
n=278 participants at risk
Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.8%
59/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
24.1%
67/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.1%
11/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
5.8%
16/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.3%
28/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
14.7%
41/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.1%
95/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
41.7%
116/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Eye disorders
Lacrimation increased
|
5.9%
16/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
5.4%
15/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Gastrointestinal disorders
Constipation
|
8.9%
24/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
6.5%
18/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
19.2%
52/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
18.0%
50/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Gastrointestinal disorders
Nausea
|
36.5%
99/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
33.8%
94/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Gastrointestinal disorders
Stomatitis
|
17.0%
46/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
11.9%
33/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
27/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
9.4%
26/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
General disorders
Asthenia
|
17.3%
47/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
13.7%
38/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
General disorders
Fatigue
|
19.6%
53/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
22.3%
62/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
General disorders
Oedema peripheral
|
3.0%
8/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
6.5%
18/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
General disorders
Pyrexia
|
11.4%
31/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
10.8%
30/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
17/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
2.9%
8/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.4%
31/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
10.1%
28/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
12.2%
33/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
12.2%
34/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Investigations
Alanine aminotransferase increased
|
6.6%
18/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
10.8%
30/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Investigations
Aspartate aminotransferase increased
|
5.2%
14/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
9.0%
25/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Investigations
Ejection fraction decreased
|
7.4%
20/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
3.2%
9/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Investigations
Neutrophil count decreased
|
5.2%
14/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
4.7%
13/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
21/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
7.2%
20/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
34/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
14.4%
40/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.1%
11/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
7.2%
20/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
27/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
10.1%
28/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Nervous system disorders
Dizziness
|
5.2%
14/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
2.9%
8/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Nervous system disorders
Headache
|
9.2%
25/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
7.6%
21/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.2%
14/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
7.2%
20/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Psychiatric disorders
Insomnia
|
5.9%
16/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
2.5%
7/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
14/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
5.0%
14/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
72.3%
196/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
76.6%
213/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.6%
18/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
3.6%
10/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
|
Vascular disorders
Hypertension
|
7.0%
19/271 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
4.0%
11/278 • Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place