TriangleNCT01942135 · OUTCOME
Duration of Response (DR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until end of treatment (assessed up to 2 years)
What was measured
DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as \[the date response ended (ie, date of PD or death) - first CR or PR date + 1)\]/30.4. Kaplan-Meier estimate of median of the DR is provided below. No inferential statistical analysis were done for DR. The DR was only calculated for the participants with a CR or PR.
Analysis population: The ITT population or full analysis set included all participants who were randomized, with study intervention, regardless of whether participants received the study intervention or received a different drug from that to which they were randomized.
Groups in this outcome
Palbociclib + Fulvestrant
Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
Placebo + Fulvestrant
Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
| Group | Source count |
|---|---|
| Palbociclib + Fulvestrant | 347 |
| Placebo + Fulvestrant | 174 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | 10.4 | Not reported | 8.3 | NA | Due to less follow up time and insufficient number of participants having duration response. |
| Placebo + Fulvestrant | 9.0 | Not reported | 5.6 | NA | Due to less follow up time and insufficient number of participants having duration response. |
Complete source fields
- classes
- categories
- measurements
- comment
- Due to less follow up time and insufficient number of participants having duration response.
- group Id
- OG000
- lower Limit
- 8.3
- upper Limit
- NA
- value
- 10.4
- comment
- Due to less follow up time and insufficient number of participants having duration response.
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- NA
- value
- 9.0
- denoms
- counts
- group Id
- OG000
- value
- 347
- group Id
- OG001
- value
- 174
- units
- Participants
- description
- DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as \[the date response ended (ie, date of PD or death) - first CR or PR date + 1)\]/30.4. Kaplan-Meier estimate of median of the DR is provided below. No inferential statistical analysis were done for DR. The DR was only calculated for the participants with a CR or PR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
- id
- OG000
- title
- Palbociclib + Fulvestrant
- description
- Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
- id
- OG001
- title
- Placebo + Fulvestrant
- param Type
- MEDIAN
- population Description
- The ITT population or full analysis set included all participants who were randomized, with study intervention, regardless of whether participants received the study intervention or received a different drug from that to which they were randomized.
- reporting Status
- POSTED
- time Frame
- From randomization until end of treatment (assessed up to 2 years)
- title
- Duration of Response (DR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice