Ignite Creation Date:
2024-05-06 @ 10:19 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03220178
Status:
TERMINATED
Last Update Posted:
2022-01-06
First Post:
2017-07-06
Brief Title:
Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy
Sponsor:
Palleos Healthcare GmbH
Organization:
Palleos Healthcare GmbH
Study Overview
Official Title:
PRECYCLE Multicenter Randomized Phase IV Intergroup Trial to Evaluate the Impact of eHealth-based Patient Reported Outcome PRO Assessment on Quality of Life in Patients With Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to COVID-19 pandemic study cannot be finished in planned timeframe
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECYCLE
Brief Summary:
In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR HER2-locally advanced or metastatic breast cancer treated with the cyclin dependent kinase 46 CDK46 Inhibitor Palbociclib in combination with an aromatase inhibitor or fulvestrant Furthermore this approach will be combined with biomarker screening to identify predictive markers for and to learn more about adherence symptoms response and resistance
Detailed Description:
This is a multicenter 80 sites randomized parallel-group Phase IV clinical trial with the primary objective of testing the hypothesis of superiority for time to deterioration TTD in patients using the ePRO system CANKADO active over CANKADO inform version
Eligible patients will have histologically or cytologically proven diagnosis of hormone receptor positive HR human epidermal growth factor receptor 2 HER2- negative locally advanced or metastatic breast cancer and will be either candidates to receive palbociclib in combination with aromatase inhibitor or candidates to receive palbociclib in combination with fulvestrant for their locally advanced or metastatic disease Patients who are candidates for palbociclib in combination with aromatase inhibitor AI or fulvestrant will not be candidates for curative therapies For Patients who are candidates for palbociclib in combination with aromatase inhibitor or fulvestrant one prior line of chemotherapy for locally advanced or metastatic breast cancer is allowed in addition to a maximum of two lines of endocrine therapy Patients will be stratified according their eligibility of receiving palbociclib with endocrine therapy AI or fulvestrant as first or later lines
Patients allocated to the combination of palbociclib with aromatase inhibitor will receive
Palbociclib 125 mg orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment and
Aromatase inhibitor orally once-daily continuously
Pre- or peri-menopausal patients should additionally receive a Gonadotropin-Releasing-Hormon GnRH-agonist
Patients allocated to the combination of palbociclib with fulvestrant will receive
Palbociclib 125 mg orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment and
Fulvestrant 500 mg intramuscularly on Days 1 and 14 of Cycle 1 every 28 days 7 days thereafter starting
Pre- or peri-menopausal patients should additionally receive a Gonadotropin-Releasing-Hormon GnRH-agonist
Patients of each treatment group palbociclib aromatase inhibitor and palbociclibfulvestrant will randomized 21 in the Intervention Arm A CANKADO active is the fully functional CANKADO-based eHealth treatment support service including a high density observation of patient reported outcome HDOB-PRO
And in the Control Arm B CANKADO inform stands for a CANKADO-based eHealth service with a personal login On-site surveys without feedback functions for the patient will be available CANKADO inform will be used for the initial ePRO and further on-site ePROs Patients can login from at home and can document their drug intake Further features will not be available
Patients will continue to receive study treatment together with the assigned ePRO assessment until investigator assessed disease progression symptomatic deterioration unacceptable toxicity death or withdrawal of consent whichever occurs first In addition should palbociclib related toxicity mandate discontinuation patients can continue to receive fulvestrant alone
Patients discontinuing the active treatment phase will enter a follow-up period phase during survival further progression and new anti-cancer therapy information will be collected once a year up to 48 month after randomization
In addition biomarkers will be assessed as a scientific program within this study Tumor material tumor tissue and Blood samples plasma and serum will be collected Tumor tissue from available primary tumor and available biopsies from recurrent disease will be collected Blood samples will be collected at four time points cycle 1 C1D1 after 2 weeks C1D14 after 12 weeks C4D1 and upon progression End of treatment
Eligible patients will have histologically or cytologically proven diagnosis of hormone receptor positive HR human epidermal growth factor receptor 2 HER2- negative locally advanced or metastatic breast cancer and will be either candidates to receive palbociclib in combination with aromatase inhibitor or candidates to receive palbociclib in combination with fulvestrant for their locally advanced or metastatic disease Patients who are candidates for palbociclib in combination with aromatase inhibitor AI or fulvestrant will not be candidates for curative therapies For Patients who are candidates for palbociclib in combination with aromatase inhibitor or fulvestrant one prior line of chemotherapy for locally advanced or metastatic breast cancer is allowed in addition to a maximum of two lines of endocrine therapy Patients will be stratified according their eligibility of receiving palbociclib with endocrine therapy AI or fulvestrant as first or later lines
Patients allocated to the combination of palbociclib with aromatase inhibitor will receive
Palbociclib 125 mg orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment and
Aromatase inhibitor orally once-daily continuously
Pre- or peri-menopausal patients should additionally receive a Gonadotropin-Releasing-Hormon GnRH-agonist
Patients allocated to the combination of palbociclib with fulvestrant will receive
Palbociclib 125 mg orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment and
Fulvestrant 500 mg intramuscularly on Days 1 and 14 of Cycle 1 every 28 days 7 days thereafter starting
Pre- or peri-menopausal patients should additionally receive a Gonadotropin-Releasing-Hormon GnRH-agonist
Patients of each treatment group palbociclib aromatase inhibitor and palbociclibfulvestrant will randomized 21 in the Intervention Arm A CANKADO active is the fully functional CANKADO-based eHealth treatment support service including a high density observation of patient reported outcome HDOB-PRO
And in the Control Arm B CANKADO inform stands for a CANKADO-based eHealth service with a personal login On-site surveys without feedback functions for the patient will be available CANKADO inform will be used for the initial ePRO and further on-site ePROs Patients can login from at home and can document their drug intake Further features will not be available
Patients will continue to receive study treatment together with the assigned ePRO assessment until investigator assessed disease progression symptomatic deterioration unacceptable toxicity death or withdrawal of consent whichever occurs first In addition should palbociclib related toxicity mandate discontinuation patients can continue to receive fulvestrant alone
Patients discontinuing the active treatment phase will enter a follow-up period phase during survival further progression and new anti-cancer therapy information will be collected once a year up to 48 month after randomization
In addition biomarkers will be assessed as a scientific program within this study Tumor material tumor tissue and Blood samples plasma and serum will be collected Tumor tissue from available primary tumor and available biopsies from recurrent disease will be collected Blood samples will be collected at four time points cycle 1 C1D1 after 2 weeks C1D14 after 12 weeks C4D1 and upon progression End of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None