Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

Short name TELEPIK

NCTNCT04862143Other idCBYL719A03201Other id2020-005882-15

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Study early terminated due to low enrollment compared to the anticipated figures

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 2 participants (actual)
Sponsor: Novartis Pharmaceuticals · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Sweden
Start: 8 Mar 2022
Primary completion: 19 Sept 2022
Completion: 19 Sept 2022
First posted: 27 Apr 2021
Last update posted: 20 Jun 2024
Conditions: Advanced Breast Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20222023

Ph 2
TELEPIK
NCT04862143
8 Mar 2022 to 19 Sept 2022
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.

Interventions

AlpelisibDrug
FulvestrantDrug
GoserelinDrug

Arms1

Experimental
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Participant Satisfaction Assessed Through the Trial Feedback Questionnaire (TFQ)
Time frame · Baseline, and on Day 1 of Cycle 4 and 7. Cycle= 28 days
Registry description
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).

Secondary outcomes(12)

Patient Retention on the Decentralized Clinical Trial (DCT) Approach
Time frame · At 3 and 6 months
Registry description
Patient retention on the DCT approach was calculated as the percentage of participants on remote monitoring for participants still on treatment
Number of Unscheduled In-clinic Visits
Time frame · From the date of the first study treatment up to the end of study, assessed up to 6 months
Registry description
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
Number of Unscheduled In-clinic Visits Because of Safety Reasons
Time frame · From the date of the first study treatment up to the end of study, assessed up to 6 months
Registry description
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
Number of Unscheduled In-clinic Visits Per Participant in the Study
Time frame · From the date of the first study treatment up to the end of study, assessed up to 6 months
Registry description
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
Number of Participants Who Discontinue Treatment Due to Adverse Events (AEs)
Time frame · From the date of the first study treatment up to the end of treatment, assessed up to 6 months
Registry description
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
Number of Participants With Dose Reductions/Interruptions for Alpelisib
Time frame · From the date of the first study treatment up to the end of treatment, assessed up to 6 months
Registry description
Number of participants with dose reductions and interruptions for alpelisib
Number of Participants With Adverse Events of Special Interest (AESIs)- Hyperglycemia, Rash and Diarrhea
Time frame · From the date of the first study treatment up to the end of study, assessed up to 6 months
Registry description
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.
Number of Participants With Adverse Events (AEs) Leading to In-clinic Visits
Time frame · From the date of the first study treatment up to the end of study, assessed up to 6 months
Registry description
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.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame · Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days
Registry description
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
EuroQol 5-Dimension 5-Level (EQ-5D-5L)- Visual Analog Scale (VAS) Score
Time frame · Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days
Registry description
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
Brief Pain Inventory Short Form (BPI-SF) Scores
Time frame · Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days
Registry description
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.
Number of Participants With Progression-free Survival (PFS) According to RECIST 1.1
Time frame · Up to 6 months
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Baseline, and on Day 1 of Cycle 4 and 7. Cycle= 28 days

Participant Satisfaction Assessed Through the Trial Feedback Questionnaire (TFQ)

Group	Value (Score on a Scale)
Alpelisib + Fulvestrant	99.5

Secondary and other outcome results(7)

Secondary outcomeCount of participants· At 3 and 6 months

Patient Retention on the Decentralized Clinical Trial (DCT) Approach

Group	Value (Participants)
Alpelisib + Fulvestrant	1

Secondary outcomeNumber· From the date of the first study treatment up to the end of study, assessed up to 6 months

Number of Unscheduled In-clinic Visits

Group	Value (Visits)
Alpelisib + Fulvestrant	0

Secondary outcomeMedian· From the date of the first study treatment up to the end of study, assessed up to 6 months

Number of Unscheduled In-clinic Visits Because of Safety Reasons

Group	Value (Visits)
Alpelisib + Fulvestrant	0

Secondary outcomeMedian· From the date of the first study treatment up to the end of study, assessed up to 6 months

Number of Unscheduled In-clinic Visits Per Participant in the Study

Group	Value (Visits per participant)
Alpelisib + Fulvestrant	0

Secondary outcomeCount of participants· From the date of the first study treatment up to the end of treatment, assessed up to 6 months

Number of Participants Who Discontinue Treatment Due to Adverse Events (AEs)

Group	Value (Participants)
Alpelisib + Fulvestrant	1

Secondary outcomeCount of participants· From the date of the first study treatment up to the end of treatment, assessed up to 6 months

Number of Participants With Dose Reductions/Interruptions for Alpelisib

Group	Value (Participants)
Alpelisib + Fulvestrant	1

Secondary outcomeCount of participants· From the date of the first study treatment up to the end of study, assessed up to 6 months

Number of Participants With Adverse Events of Special Interest (AESIs)- Hyperglycemia, Rash and Diarrhea

Group	Value (Participants)
Alpelisib + Fulvestrant	1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Alpelisib + FulvestrantParticipants 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.	0 / 2	0 / 2	2 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 99 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Key Inclusion Criteria: 1. Participant is an adult ≥18 years old at the time of consent 2. Participant with ABC (loco regionally recurrent or metastatic) not amenable to curative therapy. 3. Participant with a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PR-positive breast cancer by local laboratory. 4. Participant with a confirmed HER2-negative ABC. 5. Participant with a pathology report confirming PIK3CA mutant status by a certified laboratory using a validated PIK3CA mutation assay (from either tissue or blood). 6. Participant was willing to operate a smartphone compatible with the software of the medical device and willing to manage applications 7. Participant was willing to use the telemedicine platform and to follow the remote participant monitoring procedure. Key Exclusion Criteria: 1. Participant had received prior treatment with any PI3K, mTOR or AKT inhibitor. 2. Participant with known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant. 3. Participant participated in a prior investigational study within 30 days prior to the start of trial treatment or within 5 half-lives of the trial treatment, whichever was longer.

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