Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 (TELEPIK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04862143
Recruitment Status : Not yet recruiting
First Posted : April 27, 2021
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The study is 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.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: Alpelisib Drug: fulvestrant Phase 2

Detailed Description:

Open-label, single arm, multi-center, Phase II interventional pilot trial. Primary objective will be to assess participant satisfaction with the decentralized clinical trial (DCT) experience.

The trial will enroll men and pre- and post-menopausal women with a HR-positive/HER2-negative ABC (loco regionally recurrent not amenable to curative therapy or metastatic) with a PIK3CA mutation, which progressed on or after endocrine-based treatment.

Participants will receive alpelisib 300 mg daily and fulvestrant 500 mg administered intramuscularly on Cycle 1, Day 1 and Cycle 1, Day 15, and on Day 1 of each cycle thereafter until Cycle 12.

Pre-menopausal women will receive goserelin 3.6 mg on Day 1 of each cycle.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Multicenter, Pilot-trial Evaluating the Safety and Utility of a Hybrid Decentralized Clinical Trial (DCT) Approach Using a TELEmedicine Platform in Patients With HR-positive/HER2-negative Advanced Breast Cancer With a PIK3CA Mutation Treated With Alpelisib - Fulvestrant TELEPIK Trial
Estimated Study Start Date : November 30, 2021
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arm Intervention/treatment
Experimental: single arm
alpelisib 300 mg daily and fulvestrant 500 mg administered intramuscularly on Cycle 1, Day 1 and Cycle 1, Day 15, and on Day 1 of each cycle thereafter until Cycle 12.
Drug: Alpelisib
Alpelisib 300 mg daily up to 12 cycles of 28 days each

Drug: fulvestrant
fulvestrant 500 mg administered intramuscularly on Cycle 1, Day 1 and Cycle 1, Day 15, and on Day 1 of each cycle thereafter until Cycle 12.




Primary Outcome Measures :
  1. Participant satisfaction with the decentralized clinical trial (DCT) experience [ Time Frame: up to 12 months ]
    change in the Trial Feedback Questionnaire (TFQ) assessed at the start of the trial, every 12 weeks, and at the end of trial through the Trial Feedback Questionnaire (TFQ)


Secondary Outcome Measures :
  1. Patient retention on DCT [ Time Frame: 3, 6, 12 months ]
    Proportion of participants on remote monitoring at 3, 6, 12 months for participants still on treatment.

  2. Compliance to treatment [ Time Frame: up to 12 months ]
    Overall compliance

  3. Proportion of participants with AESIs (hyperglicemia, rash and diarrhea) [ Time Frame: up to 12 months ]
    Adverse events of special interest (AESIs) per Common Terminology Criteria for Adverse Events (CTCAE) v4.03

  4. Proportion of participants with AEs leading to in-clinic visits [ Time Frame: up to 12 months ]
    Adverse events (AEs) that lead to in-clinic visits.

  5. Change from baseline in the EORTC QLQ C30 score. [ Time Frame: baseline, 3,6,9,12 months ]
    The European Organization for Research and Treatment of Cancer's core quality of life questionnaire (EORTC QLQ-C30) contains 30 items and is composed of both multi-item scales and single item measures. These include 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/QoL scale.

  6. Progression-free survival (PFS) according to RECIST 1.1 [ Time Frame: 3,6,9,12 months ]
    Effectiveness of alpelisib plus fulvestrant

  7. Total number of unscheduled in-clinic visits because of safety reasons [ Time Frame: up to 12 months ]
    safe and suitable remote management of patients

  8. Total number of unscheduled in-clinic visits and the reason [ Time Frame: up to 12 months ]
    safe and suitable remote management of patients

  9. Number of unscheduled in-clinic visits per participant in the study [ Time Frame: up to 12 months ]
    safe and suitable remote management of patients

  10. Discontinuation rate related to adverse events [ Time Frame: up to 12 months ]
    safe and suitable remote management of patients

  11. Number and proportion of AEs leading to in-clinic visits [ Time Frame: up to 12 months ]
    AEs of special interest (AESIs) and AEs leading to in-clinic visits

  12. Change from baseline in the EQ-5D-5L score [ Time Frame: baseline, 3,6,9,12 months ]
    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. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

  13. Change from baseline in the BPI-SF score [ Time Frame: baseline, 3,6,9,12 months ]
    The Brief Pain Inventory Short Form (BPI-SF) is a self-administered assessment tool validated to assess pain The basic aim of the BPI is to provide the information on the intensity of pain, along with the degree to which the pain interferes with the everyday functioning of life. The BPI uses simple numeric rating scales from 0 (no pain) to 10 (severe pain).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 is a man or a pre- or post-menopausal woman.
  7. Participant is willing to operate a smartphone compatible with the software of the medical device and willing to manage applications
  8. Participant is willing to use the telemedicine platform and to follow the remote participant monitoring procedure.
  9. Participant has signed an informed consent form before any trial

Exclusion Criteria:

  1. Participant has 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 is longer.

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862143


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04862143    
Other Study ID Numbers: CBYL719A03201
2020-005882-15 ( EudraCT Number )
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Decentralized clinical trial
advanced breast cancer
PIK3CA mutation
alpelisib
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs