TriangleNCT04579380 · OUTCOME
Confirmed Objective Response Rate (cORR) as Assessed by Investigator
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
- 90% Confidence Interval
- Time frame
- From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months)
What was measured
Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeter (mm). PR: at least a greater than or equal to (\>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least \>=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).
Analysis population: The Response-Evaluable analysis set includes all participants with measurable disease who meet the following 3 criteria: (1) had a baseline disease assessment, (2) received study treatment, and (3) had post-baseline disease assessment or discontinued treatment due to documented disease progression or clinical progression.
Groups in this outcome
Tucatinib+Trastuzumab (Cohort 1)
Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 2)
Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 3)
Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 4)
Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 5)
Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 6)
Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 7)
Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
Tucatinib+Trastuzumab (Cohort 9)
Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
| Group | Source count |
|---|---|
| Tucatinib+Trastuzumab (Cohort 1) | 11 |
| Tucatinib+Trastuzumab (Cohort 2) | 30 |
| Tucatinib+Trastuzumab (Cohort 3) | 30 |
| Tucatinib+Trastuzumab (Cohort 4) | 25 |
| Tucatinib+Trastuzumab (Cohort 5) | 12 |
| Tucatinib+Trastuzumab (Cohort 6) | 31 |
| Tucatinib+Trastuzumab (Cohort 7) | 13 |
| Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8) | 31 |
| Tucatinib+Trastuzumab (Cohort 9) | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tucatinib+Trastuzumab (Cohort 1) | 27.3 | Not reported | 7.9 | 56.4 | Not reported |
| Tucatinib+Trastuzumab (Cohort 2) | 13.3 | Not reported | 4.7 | 28.0 | Not reported |
| Tucatinib+Trastuzumab (Cohort 3) | 46.7 | Not reported | 30.8 | 63.0 | Not reported |
| Tucatinib+Trastuzumab (Cohort 4) | 8.0 | Not reported | 1.4 | 23.1 | Not reported |
| Tucatinib+Trastuzumab (Cohort 5) | 8.3 | Not reported | 0.4 | 33.9 | Not reported |
| Tucatinib+Trastuzumab (Cohort 6) | 22.6 | Not reported | 11.1 | 38.3 | Not reported |
| Tucatinib+Trastuzumab (Cohort 7) | 0 | Not reported | 0.0 | 20.6 | Not reported |
| Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8) | 41.9 | Not reported | 26.9 | 58.2 | Not reported |
| Tucatinib+Trastuzumab (Cohort 9) | 10.3 | Not reported | 2.9 | 24.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.9
- upper Limit
- 56.4
- value
- 27.3
- group Id
- OG001
- lower Limit
- 4.7
- upper Limit
- 28.0
- value
- 13.3
- group Id
- OG002
- lower Limit
- 30.8
- upper Limit
- 63.0
- value
- 46.7
- group Id
- OG003
- lower Limit
- 1.4
- upper Limit
- 23.1
- value
- 8.0
- group Id
- OG004
- lower Limit
- 0.4
- upper Limit
- 33.9
- value
- 8.3
- group Id
- OG005
- lower Limit
- 11.1
- upper Limit
- 38.3
- value
- 22.6
- group Id
- OG006
- lower Limit
- 0.0
- upper Limit
- 20.6
- value
- 0
- group Id
- OG007
- lower Limit
- 26.9
- upper Limit
- 58.2
- value
- 41.9
- group Id
- OG008
- lower Limit
- 2.9
- upper Limit
- 24.6
- value
- 10.3
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 30
- group Id
- OG003
- value
- 25
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 31
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 31
- group Id
- OG008
- value
- 29
- units
- Participants
- description
- Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeter (mm). PR: at least a greater than or equal to (\>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least \>=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG000
- title
- Tucatinib+Trastuzumab (Cohort 1)
- description
- Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG001
- title
- Tucatinib+Trastuzumab (Cohort 2)
- description
- Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG002
- title
- Tucatinib+Trastuzumab (Cohort 3)
- description
- Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG003
- title
- Tucatinib+Trastuzumab (Cohort 4)
- description
- Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG004
- title
- Tucatinib+Trastuzumab (Cohort 5)
- description
- Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG005
- title
- Tucatinib+Trastuzumab (Cohort 6)
- description
- Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG006
- title
- Tucatinib+Trastuzumab (Cohort 7)
- description
- Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG007
- title
- Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
- description
- Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- id
- OG008
- title
- Tucatinib+Trastuzumab (Cohort 9)
- param Type
- NUMBER
- population Description
- The Response-Evaluable analysis set includes all participants with measurable disease who meet the following 3 criteria: (1) had a baseline disease assessment, (2) received study treatment, and (3) had post-baseline disease assessment or discontinued treatment due to documented disease progression or clinical progression.
- reporting Status
- POSTED
- time Frame
- From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months)
- title
- Confirmed Objective Response Rate (cORR) as Assessed by Investigator
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice