NCT04191499 · OUTCOME
Plasma Concentration of Fulvestrant
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer · Source last updated 2026-06-15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/ml
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)
Analysis population: PK evaluable population included all participants who received at least one dose of study drug, had at least one post-baseline sample, and was based on the treatment participants actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Groups in this outcome
Inavo+Palbo+Fulv
Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
Pbo+Palbo+Fulv
Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
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 |
|---|
| Inavo+Palbo+Fulv | 154 |
|---|
| Pbo+Palbo+Fulv | 154 |
|---|
Reported measurements
Predose, Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Inavo+Palbo+Fulv | 154 |
|---|
| Pbo+Palbo+Fulv | 154 |
|---|
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Inavo+Palbo+Fulv | NA | NA | Not reported | Not reported | The data was not estimable as the samples were BLLQ. |
|---|
| Pbo+Palbo+Fulv | NA | NA | Not reported | Not reported | The data was not estimable as the samples were BLLQ. |
|---|
3 hours Post-dose, Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Inavo+Palbo+Fulv | 154 |
|---|
| Pbo+Palbo+Fulv | 154 |
|---|
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Inavo+Palbo+Fulv | 1.03 | 200 | Not reported | Not reported | Not reported |
|---|
| Pbo+Palbo+Fulv | 0.815 | 200 | Not reported | Not reported | Not reported |
|---|
Predose, Cycle 1 Day 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Inavo+Palbo+Fulv | 137 |
|---|
| Pbo+Palbo+Fulv | 137 |
|---|
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Inavo+Palbo+Fulv | 17.5 | 46 | Not reported | Not reported | Not reported |
|---|
| Pbo+Palbo+Fulv | 16.2 | 46 | Not reported | Not reported | Not reported |
|---|
Predose, Cycle 1 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Inavo+Palbo+Fulv | 138 |
|---|
| Pbo+Palbo+Fulv | 142 |
|---|
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Inavo+Palbo+Fulv | 11.9 | 37 | Not reported | Not reported | Not reported |
|---|
| Pbo+Palbo+Fulv | 10.9 | 42 | Not reported | Not reported | Not reported |
|---|
3 hours Post-dose, Cycle 1 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Inavo+Palbo+Fulv | 139 |
|---|
| Pbo+Palbo+Fulv | 139 |
|---|
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Inavo+Palbo+Fulv | 12.2 | 44 | Not reported | Not reported | Not reported |
|---|
| Pbo+Palbo+Fulv | 11.1 | 43 | Not reported | Not reported | Not reported |
|---|
Predose, Cycle 2 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Inavo+Palbo+Fulv | 137 |
|---|
| Pbo+Palbo+Fulv | 132 |
|---|
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Inavo+Palbo+Fulv | 18.0 | 37 | Not reported | Not reported | Not reported |
|---|
| Pbo+Palbo+Fulv | 17.3 | 37 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- The data was not estimable as the samples were BLLQ.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- The data was not estimable as the samples were BLLQ.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 154
- units
- Participants
- title
- Predose, Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 200
- value
- 1.03
- group Id
- OG001
- spread
- 200
- value
- 0.815
- denoms
- counts
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 154
- units
- Participants
- title
- 3 hours Post-dose, Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 46
- value
- 17.5
- group Id
- OG001
- spread
- 46
- value
- 16.2
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 137
- units
- Participants
- title
- Predose, Cycle 1 Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 37
- value
- 11.9
- group Id
- OG001
- spread
- 42
- value
- 10.9
- denoms
- counts
- group Id
- OG000
- value
- 138
- group Id
- OG001
- value
- 142
- units
- Participants
- title
- Predose, Cycle 1 Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 44
- value
- 12.2
- group Id
- OG001
- spread
- 43
- value
- 11.1
- denoms
- counts
- group Id
- OG000
- value
- 139
- group Id
- OG001
- value
- 139
- units
- Participants
- title
- 3 hours Post-dose, Cycle 1 Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 37
- value
- 18.0
- group Id
- OG001
- spread
- 37
- value
- 17.3
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 132
- units
- Participants
- title
- Predose, Cycle 2 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 154
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
- id
- OG000
- title
- Inavo+Palbo+Fulv
- description
- Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
- id
- OG001
- title
- Pbo+Palbo+Fulv
- param Type
- GEOMETRIC_MEAN
- population Description
- PK evaluable population included all participants who received at least one dose of study drug, had at least one post-baseline sample, and was based on the treatment participants actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)
- title
- Plasma Concentration of Fulvestrant
- type
- SECONDARY
- unit Of Measure
- ng/ml
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