Trial Outcomes & Findings for Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant (NCT NCT04862143)
NCT ID: NCT04862143
Last Updated: 2024-06-20
Results Overview
The TFQ was designed to capture the patient's experience during a clinical trial. The questionnaire consisted of 23 questions that assessed various aspects of the trial experience. Each question in the TFQ scored on a scale ranging from 1 (representing the worst response) to 5 (representing the best response). To calculate the total score, the scores obtained from each of the 23 questions were summed up. The resulting sum represented the participant's total score, which could ranged from 23 (indicating the lowest possible score) to 115 (indicating the highest possible score).
TERMINATED
PHASE2
2 participants
Baseline, and on Day 1 of Cycle 4 and 7. Cycle= 28 days
2024-06-20
Participant Flow
The study was conducted in 1 center from Sweden
Participant milestones
| Measure |
Alpelisib + Fulvestrant
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Alpelisib + Fulvestrant
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Study terminated by sponsor
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Age, Continuous
|
54 Years
STANDARD_DEVIATION 0 • n=2 Participants
|
|
Sex/Gender, Customized
Unknown
|
2 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Baseline, and on Day 1 of Cycle 4 and 7. Cycle= 28 daysPopulation: All enrolled participants who received at least one dose of any component of study treatment
The TFQ was designed to capture the patient's experience during a clinical trial. The questionnaire consisted of 23 questions that assessed various aspects of the trial experience. Each question in the TFQ scored on a scale ranging from 1 (representing the worst response) to 5 (representing the best response). To calculate the total score, the scores obtained from each of the 23 questions were summed up. The resulting sum represented the participant's total score, which could ranged from 23 (indicating the lowest possible score) to 115 (indicating the highest possible score).
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Participant Satisfaction Assessed Through the Trial Feedback Questionnaire (TFQ)
Baseline
|
99.5 Score on a Scale
Interval 92.0 to 107.0
|
|
Participant Satisfaction Assessed Through the Trial Feedback Questionnaire (TFQ)
Cycle 4 Day 1
|
89 Score on a Scale
|
|
Participant Satisfaction Assessed Through the Trial Feedback Questionnaire (TFQ)
Cycle 7 Day 1
|
98 Score on a Scale
|
SECONDARY outcome
Timeframe: At 3 and 6 monthsPopulation: Participants receiving treatment at the specified time points
Patient retention on the DCT approach was calculated as the percentage of participants on remote monitoring for participants still on treatment
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=1 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
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|---|---|
|
Patient Retention on the Decentralized Clinical Trial (DCT) Approach
3 months
|
1 Participants
|
|
Patient Retention on the Decentralized Clinical Trial (DCT) Approach
6 months
|
1 Participants
|
SECONDARY outcome
Timeframe: From the date of the first study treatment up to the end of study, assessed up to 6 monthsPopulation: All enrolled participants who received at least one dose of any component of study treatment
Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital). The total number of unscheduled in-clinic visits was evaluated
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Number of Unscheduled In-clinic Visits
|
0 Visits
|
SECONDARY outcome
Timeframe: From the date of the first study treatment up to the end of study, assessed up to 6 monthsPopulation: All enrolled participants who received at least one dose of any component of study treatment
Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital). The total number of unscheduled in-clinic visits that were prompted by safety reasons was evaluated
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Number of Unscheduled In-clinic Visits Because of Safety Reasons
|
0 Visits
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From the date of the first study treatment up to the end of study, assessed up to 6 monthsPopulation: All enrolled participants who received at least one dose of any component of study treatment
Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital). The total number of unscheduled in-clinic visits per participants was evaluated
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Number of Unscheduled In-clinic Visits Per Participant in the Study
|
0 Visits per participant
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From the date of the first study treatment up to the end of treatment, assessed up to 6 monthsPopulation: All enrolled participants who received at least one dose of any component of study treatment
An AE refers to any untoward medical occurrence, such as an unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease. The number of participants who discontinued the treatment due to adverse events was evaluated
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Number of Participants Who Discontinue Treatment Due to Adverse Events (AEs)
|
1 Participants
|
SECONDARY outcome
Timeframe: From the date of the first study treatment up to the end of treatment, assessed up to 6 monthsPopulation: All enrolled participants who received at least one dose of any study treatment
Number of participants with dose reductions and interruptions for alpelisib
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Number of Participants With Dose Reductions/Interruptions for Alpelisib
Dose interruptions
|
1 Participants
|
|
Number of Participants With Dose Reductions/Interruptions for Alpelisib
Dose reductions
|
1 Participants
|
SECONDARY outcome
Timeframe: From the date of the first study treatment up to the end of study, assessed up to 6 monthsPopulation: All enrolled participants who received at least one dose of any study treatment
AESIs (Adverse Events of Special Interest) are defined as events, whether serious or non-serious, that are of scientific and medical concern specific to the sponsor's product or program. These events may require ongoing monitoring and communication by the investigator to the sponsor. For this study, the following AESIs were defined: hyperglycemia, rash, and diarrhea. The number of participants experiencing these events per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 was evaluated.
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)- Hyperglycemia, Rash and Diarrhea
Diarrhea
|
1 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)- Hyperglycemia, Rash and Diarrhea
Hyperglycaemia
|
2 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)- Hyperglycemia, Rash and Diarrhea
Rash
|
0 Participants
|
SECONDARY outcome
Timeframe: From the date of the first study treatment up to the end of study, assessed up to 6 monthsPopulation: All enrolled participants who received at least one dose of any study treatment
An AE refers to any untoward medical occurrence, such as an unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease. The number of participants with AEs per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 leading to in-clinic visits was assessed.
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) Leading to In-clinic Visits
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 daysPopulation: All enrolled participants who received at least one dose of any study treatment. Number analyzed indicates the number of participants with data available at the designated time point.
The EORTC QLQ-C30 questionnaire contained 30 items and was composed of both multi-item scales and single item measures. These included five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global health status/quality of life (QoL) scale. All of the scales and single items ranged from 0 to 100. A high scale score represented a higher response level. Thus, a high score for a functional scale indicated a high/healthy level of functioning, a high score for the QoL indicated high QoL, but a high score for a symptom scale/single item indicated a high level of symptomatology/problems. The EORTC QLQ-C30 scores for all functional and symptom scales were evaluated
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
QoL- Baseline
|
75 Score on a Scale
Interval 67.0 to 83.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
QoL- Cycle 4 Day 1
|
83 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
QoL- Cycle 7 Day 1
|
92 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
QoL- End of Treatment
|
75 Score on a Scale
Interval 67.0 to 83.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Physical Functioning- Baseline
|
90 Score on a Scale
Interval 80.0 to 100.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Physical Functioning- Cycle 4 Day 1
|
93 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Physical Functioning- Cycle 7 Day 1
|
100 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Physical Functioning-End of Treatment
|
86.5 Score on a Scale
Interval 80.0 to 93.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Role Functioning- Baseline
|
91.5 Score on a Scale
Interval 83.0 to 100.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Role Functioning- Cycle 4 Day 1
|
100 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Role Functioning- Cycle 7 Day 1
|
100 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Role Functioning-End of Treatment
|
83.5 Score on a Scale
Interval 67.0 to 100.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Emotional Functioning- Baseline
|
71 Score on a Scale
Interval 67.0 to 75.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Emotional Functioning- Cycle 4 Day 1
|
83 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Emotional Functioning- Cycle 7 Day 1
|
92 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Emotional Functioning- End of treatment
|
83 Score on a Scale
Interval 83.0 to 83.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Cognitive Functioning- Baseline
|
91.5 Score on a Scale
Interval 83.0 to 100.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Cognitive Functioning- Cycle 4 Day 1
|
100 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Cognitive Functioning- Cycle 7 Day 1
|
100 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Cognitive Functioning- End of treatment
|
75 Score on a Scale
Interval 67.0 to 83.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social Functioning- Baseline
|
91.5 Score on a Scale
Interval 83.0 to 100.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social Functioning- Cycle 4 Day 1
|
100 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social Functioning- Cycle 7 Day 1
|
100 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social Functioning- End of treatment
|
91.5 Score on a Scale
Interval 83.0 to 100.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Fatigue- Baseline
|
22 Score on a Scale
Interval 0.0 to 44.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Fatigue- Cycle 4 Day 1
|
22 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Fatigue- Cycle 7 Day 1
|
0 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Fatigue- End of treatment
|
33 Score on a Scale
Interval 22.0 to 44.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Nausea/vomiting- Baseline
|
0 Score on a Scale
Interval 0.0 to 0.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Nausea/vomiting- Cycle 4 Day 1
|
17 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Nausea/vomiting- Cycle 7 Day 1
|
0 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Nausea/vomiting- End of treatment
|
0 Score on a Scale
Interval 0.0 to 0.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Pain- Baseline
|
8.5 Score on a Scale
Interval 0.0 to 17.0
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Pain- Cycle 4 Day 1
|
0 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Pain- Cycle 7 Day 1
|
0 Score on a Scale
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Pain- End of treatment
|
16.5 Score on a Scale
Interval 0.0 to 33.0
|
SECONDARY outcome
Timeframe: Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 daysPopulation: All enrolled participants who received at least one dose of any study treatment. Number analyzed indicates the number of participants with data available at the designated time point.
The 5-level EQ-5D (EQ-5D-5L) questionnaire is a standardized measure of health status. The EQ-5D descriptive system comprises of the 5 following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Along with the five dimensions of health, the EQ-5D-5L includes a VAS where respondents rate their overall health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. The EQ-5D-5L VAS scores were evaluated
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
EuroQol 5-Dimension 5-Level (EQ-5D-5L)- Visual Analog Scale (VAS) Score
Baseline
|
80 Score on a scale
Interval 75.0 to 85.0
|
|
EuroQol 5-Dimension 5-Level (EQ-5D-5L)- Visual Analog Scale (VAS) Score
Cycle 4 Day 1
|
93 Score on a scale
|
|
EuroQol 5-Dimension 5-Level (EQ-5D-5L)- Visual Analog Scale (VAS) Score
Cycle 7 Day 1
|
95 Score on a scale
|
|
EuroQol 5-Dimension 5-Level (EQ-5D-5L)- Visual Analog Scale (VAS) Score
End of treatment
|
82.5 Score on a scale
Interval 70.0 to 95.0
|
SECONDARY outcome
Timeframe: Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 daysPopulation: All enrolled participants who received at least one dose of any study treatment. Number analyzed indicates the number of participants with data available at the designated time point.
The BPI-SF was a questionnaire used to assess pain intensity and interference with daily activities. The Pain Severity Subscale included four questions asking individuals to rate their pain intensity on a scale from 0 to 10, with higher scores indicating more severe pain. The Pain Interference Subscale consisted of seven items that assessed how pain had interfered with activities, rated on the same scale. Both subscales had a total score range of 0 to 10, with higher scores indicating more significant pain or interference.
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Brief Pain Inventory Short Form (BPI-SF) Scores
Pain severity- Baseline
|
1.63 Score on a scale
Interval 1.25 to 2.0
|
|
Brief Pain Inventory Short Form (BPI-SF) Scores
Pain severity- Cycle 4 Day 1
|
0 Score on a scale
|
|
Brief Pain Inventory Short Form (BPI-SF) Scores
Pain severity- Cycle 7 Day 1
|
0.75 Score on a scale
|
|
Brief Pain Inventory Short Form (BPI-SF) Scores
Pain severity- End of treatment
|
1.13 Score on a scale
Interval 0.0 to 2.25
|
|
Brief Pain Inventory Short Form (BPI-SF) Scores
Pain interference- Baseline
|
0.79 Score on a scale
Interval 0.0 to 1.57
|
|
Brief Pain Inventory Short Form (BPI-SF) Scores
Pain interference- Cycle 4 Day 1
|
0 Score on a scale
|
|
Brief Pain Inventory Short Form (BPI-SF) Scores
Pain interference- Cycle 7 Day 1
|
0 Score on a scale
|
|
Brief Pain Inventory Short Form (BPI-SF) Scores
Pain interference- End of treatment
|
1.07 Score on a scale
Interval 0.0 to 2.14
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: All enrolled participants who received at least one dose of any component of study treatment
The number of participants with PFS was defined as the count of participants who did not experience disease progression or death due to any cause during the study. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on local radiology review.
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=2 Participants
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Number of Participants With Progression-free Survival (PFS) According to RECIST 1.1
|
2 Participants
|
Adverse Events
Alpelisib + Fulvestrant
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alpelisib + Fulvestrant
n=2 participants at risk
Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
100.0%
2/2 • From start up to end of study, assessed up to 6 months
|
|
General disorders
Fatigue
|
100.0%
2/2 • From start up to end of study, assessed up to 6 months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • From start up to end of study, assessed up to 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • From start up to end of study, assessed up to 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
1/2 • From start up to end of study, assessed up to 6 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • From start up to end of study, assessed up to 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • From start up to end of study, assessed up to 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
50.0%
1/2 • From start up to end of study, assessed up to 6 months
|
|
Gastrointestinal disorders
Gastritis
|
50.0%
1/2 • From start up to end of study, assessed up to 6 months
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
1/2 • From start up to end of study, assessed up to 6 months
|
|
Investigations
Weight decreased
|
50.0%
1/2 • From start up to end of study, assessed up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER