NCT01853748 · OUTCOME
Number of Participants of Clinically Relevant Toxicities (CRT)
T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) · Source last updated 2026-02-19
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 5 years after completion of study treatment or until death, whichever occurs first.
What was measured
Clinically relevant toxicities will include the composite incidence of grade 3 or higher non-hematologic toxicity, grade 2 or higher neurotoxicity, and grade 4 or higher hematologic toxicity. These toxicities will only be assessed at the pre-specified toxicity-assessment visits. In addition, the following events, regardless of timing of their occurrence, will also count towards the composite endpoint: febrile neutropenia, any toxicity requiring dose-delay, discontinuation of any study treatment (Paclitaxel, Trastuzumab, or T-DM1) for toxicity, and any serious adverse event (SAE).
Groups in this outcome
Trastuzumab Emtansine (T-DM1)
T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
Paclitaxel + Trastuzumab
paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
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 |
|---|
| Trastuzumab Emtansine (T-DM1) | 383 |
|---|
| Paclitaxel + Trastuzumab | 114 |
|---|
Reported measurements
Grade 3 or higher non-hematologic toxicity
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Emtansine (T-DM1) | 36 | Not reported | Not reported | Not reported | Not reported |
|---|
| Paclitaxel + Trastuzumab | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2 or higher neurotoxicity
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Emtansine (T-DM1) | 42 | Not reported | Not reported | Not reported | Not reported |
|---|
| Paclitaxel + Trastuzumab | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4 or higher hematologic toxicity
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Emtansine (T-DM1) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Paclitaxel + Trastuzumab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Emtansine (T-DM1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Paclitaxel + Trastuzumab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Any toxicity requiring dose delay
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Emtansine (T-DM1) | 106 | Not reported | Not reported | Not reported | Not reported |
|---|
| Paclitaxel + Trastuzumab | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
Any toxicity requiring early discontinuation of protocol therapy
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Emtansine (T-DM1) | 67 | Not reported | Not reported | Not reported | Not reported |
|---|
| Paclitaxel + Trastuzumab | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious adverse event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Emtansine (T-DM1) | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Paclitaxel + Trastuzumab | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 13
- title
- Grade 3 or higher non-hematologic toxicity
- categories
- measurements
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 26
- title
- Grade 2 or higher neurotoxicity
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- title
- Grade 4 or higher hematologic toxicity
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- Febrile neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 30
- title
- Any toxicity requiring dose delay
- categories
- measurements
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 7
- title
- Any toxicity requiring early discontinuation of protocol therapy
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 6
- title
- Serious adverse event
- denoms
- counts
- group Id
- OG000
- value
- 383
- group Id
- OG001
- value
- 114
- units
- Participants
- description
- Clinically relevant toxicities will include the composite incidence of grade 3 or higher non-hematologic toxicity, grade 2 or higher neurotoxicity, and grade 4 or higher hematologic toxicity. These toxicities will only be assessed at the pre-specified toxicity-assessment visits. In addition, the following events, regardless of timing of their occurrence, will also count towards the composite endpoint: febrile neutropenia, any toxicity requiring dose-delay, discontinuation of any study treatment (Paclitaxel, Trastuzumab, or T-DM1) for toxicity, and any serious adverse event (SAE).
- groups
- description
- T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
- id
- OG000
- title
- Trastuzumab Emtansine (T-DM1)
- description
- paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
- id
- OG001
- title
- Paclitaxel + Trastuzumab
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 5 years after completion of study treatment or until death, whichever occurs first.
- title
- Number of Participants of Clinically Relevant Toxicities (CRT)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle