NCT03493854 · OUTCOME
Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to Distant Recurrence-Free Interval (DRFI) Criteria
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer · Source last updated 2024-06-26
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At 1, 2, 3, and 4 years
What was measured
The distant recurrence-free interval (DRFI) is defined as the time between randomization and the date of distant breast cancer recurrence.
Analysis population: ITT Population. The number analyzed at each landmark timepoint represents the number of participants who were remaining at risk for an event.
Groups in this outcome
Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy
Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \[G-CSF\] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.
Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy
Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 252 |
|---|
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 248 |
|---|
Reported measurements
1 Year
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 244 |
|---|
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 239 |
|---|
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 99.59 | Not reported | 98.80 | 100.00 | Not reported |
|---|
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 99.58 | Not reported | 98.77 | 100.00 | Not reported |
|---|
2 Years
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 231 |
|---|
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 224 |
|---|
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 95.88 | Not reported | 93.39 | 98.38 | Not reported |
|---|
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 95.37 | Not reported | 92.70 | 98.04 | Not reported |
|---|
3 Years
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 221 |
|---|
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 216 |
|---|
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 93.77 | Not reported | 90.72 | 96.82 | Not reported |
|---|
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 93.23 | Not reported | 90.02 | 96.43 | Not reported |
|---|
4 Years
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 212 |
|---|
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 210 |
|---|
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 92.49 | Not reported | 89.15 | 95.83 | Not reported |
|---|
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 91.92 | Not reported | 88.44 | 95.41 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 0.61
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.24
- non Inferiority Comment
- Descriptive analysis only
- non Inferiority Type
- OTHER
- p Value
- 0.6291
- param Type
- Hazard Ratio (HR)
- param Value
- 1.17
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.61
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.24
- non Inferiority Comment
- Descriptive analysis only
- non Inferiority Type
- OTHER
- p Value
- 0.6291
- param Type
- Hazard Ratio (HR)
- param Value
- 1.17
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 98.80
- upper Limit
- 100.00
- value
- 99.59
- group Id
- OG001
- lower Limit
- 98.77
- upper Limit
- 100.00
- value
- 99.58
- denoms
- counts
- group Id
- OG000
- value
- 244
- group Id
- OG001
- value
- 239
- units
- Participants
- title
- 1 Year
- categories
- measurements
- group Id
- OG000
- lower Limit
- 93.39
- upper Limit
- 98.38
- value
- 95.88
- group Id
- OG001
- lower Limit
- 92.70
- upper Limit
- 98.04
- value
- 95.37
- denoms
- counts
- group Id
- OG000
- value
- 231
- group Id
- OG001
- value
- 224
- units
- Participants
- title
- 2 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 90.72
- upper Limit
- 96.82
- value
- 93.77
- group Id
- OG001
- lower Limit
- 90.02
- upper Limit
- 96.43
- value
- 93.23
- denoms
- counts
- group Id
- OG000
- value
- 221
- group Id
- OG001
- value
- 216
- units
- Participants
- title
- 3 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 89.15
- upper Limit
- 95.83
- value
- 92.49
- group Id
- OG001
- lower Limit
- 88.44
- upper Limit
- 95.41
- value
- 91.92
- denoms
- counts
- group Id
- OG000
- value
- 212
- group Id
- OG001
- value
- 210
- units
- Participants
- title
- 4 Years
- denoms
- counts
- group Id
- OG000
- value
- 252
- group Id
- OG001
- value
- 248
- units
- Participants
- description
- The distant recurrence-free interval (DRFI) is defined as the time between randomization and the date of distant breast cancer recurrence.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \[G-CSF\] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.
- id
- OG000
- title
- Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy
- description
- Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.
- id
- OG001
- title
- Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy
- param Type
- NUMBER
- population Description
- ITT Population. The number analyzed at each landmark timepoint represents the number of participants who were remaining at risk for an event.
- reporting Status
- POSTED
- time Frame
- At 1, 2, 3, and 4 years
- title
- Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to Distant Recurrence-Free Interval (DRFI) Criteria
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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