Ignite Creation Date:
2024-05-06 @ 10:19 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03227328
Status:
UNKNOWN
Last Update Posted:
2020-04-21
First Post:
2017-07-19
Brief Title:
CDK46-inhibitor or Chemotherapy in Combination With ENDOcrine Therapy for Advanced Breast Cancer KENDO
Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Organization:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Overview
Official Title:
Group Sequential Response Adaptive Randomized Clinical Trial of Concomitant Chemotherapy Plus Endocrine Therapy Versus Cyclin-dependent Kinase 46 CDK46 Inhibitor Plus Endocrine Therapy for Advanced Hormone Receptor-positive HER2-negative Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KENDO
Brief Summary:
Prospective open label multicenter group sequential response adaptive randomized phase 2 study comparing two treatments for locally advanced or metastatic luminal breast cancer
Arm A concomitant cyclin-dependent Kinase 46 CDK46 inhibitor palbociclib ribociclib or abemaciclib plus endocrine therapy aromatase inhibitor AI or fulvestrant
Arm B chemotherapy plus endocrine therapy AI or fulvestrant administered either concomitantly from the beginning of chemotherapy or sequentially after 4-6 months of chemotherapy Treatments will continue until disease progression or toxicity or patient refusal
Arm A concomitant cyclin-dependent Kinase 46 CDK46 inhibitor palbociclib ribociclib or abemaciclib plus endocrine therapy aromatase inhibitor AI or fulvestrant
Arm B chemotherapy plus endocrine therapy AI or fulvestrant administered either concomitantly from the beginning of chemotherapy or sequentially after 4-6 months of chemotherapy Treatments will continue until disease progression or toxicity or patient refusal
Detailed Description:
Group sequential response adaptive randomized clinical trial of concomitant chemotherapy plus endocrine therapy versus cyclin-dependent Kinase 46 CDK46 inhibitor plus endocrine therapy for advanced hormone receptor-positive HER2-negative breast cancer Primary Objective To compare the efficacy of concomitant CDK46 inhibitor plus endocrine therapy versus chemotherapy plus endocrine therapy administered either concomitantly from the beginning or sequentially in terms of progression-free survival PFS
Secondary objectives To compare between treatment arms
quality of life EORTC quality of life questionnaireQLQ QLQ -C30 and QLQ-BR23
toxicity CTCAE version 50
time to treatment failure
best response rate
duration of response
clinical benefit rate
overall survival OS
PFS and clinical benefit with the subsequent line of treatment after cross-over CDK46 inhibitors plus endocrine therapy in patients treated with chemotherapy plus endocrine therapy chemotherapy with or without endocrine therapy in patients treated with CDK46 inhibitors plus endocrine therapy
correlative biomarkers of response to CDK46 inhibitors and chemotherapy
tissue markers on the primary tumor and or metastatic tissue
circulating markers eg CTCs ctDNA
The patients will be allocated according to block randomization until two events are observed in each arm and then according to the time-to-event adaptation of the group sequential Doubly-adaptive Biased Coin Design DBCD whose allocation probabilities are computed at the end of the block randomization and after around 70 and 85 of the 150 maximum patients are enrolled during a 23 month period At these last two ie after 105 and 128 patients respectively interim analysis on efficacy will be carried out allowing for early stopping At the end of the 16-month follow up administrative censoring is introduced Therefore the total study duration is 39 months
Previous results on palbociclib and fulvestrant combination in second line and the characteristics of our target population lead us to assume a median PFS of 8 and 12 months for arm A and B respectively Under this scenario for a sample size of at the most 150 patients the proposed design strategy has led to a simulated power of 0911 compared with a 0717 one for the Complete Randomisation design
Secondary objectives To compare between treatment arms
quality of life EORTC quality of life questionnaireQLQ QLQ -C30 and QLQ-BR23
toxicity CTCAE version 50
time to treatment failure
best response rate
duration of response
clinical benefit rate
overall survival OS
PFS and clinical benefit with the subsequent line of treatment after cross-over CDK46 inhibitors plus endocrine therapy in patients treated with chemotherapy plus endocrine therapy chemotherapy with or without endocrine therapy in patients treated with CDK46 inhibitors plus endocrine therapy
correlative biomarkers of response to CDK46 inhibitors and chemotherapy
tissue markers on the primary tumor and or metastatic tissue
circulating markers eg CTCs ctDNA
The patients will be allocated according to block randomization until two events are observed in each arm and then according to the time-to-event adaptation of the group sequential Doubly-adaptive Biased Coin Design DBCD whose allocation probabilities are computed at the end of the block randomization and after around 70 and 85 of the 150 maximum patients are enrolled during a 23 month period At these last two ie after 105 and 128 patients respectively interim analysis on efficacy will be carried out allowing for early stopping At the end of the 16-month follow up administrative censoring is introduced Therefore the total study duration is 39 months
Previous results on palbociclib and fulvestrant combination in second line and the characteristics of our target population lead us to assume a median PFS of 8 and 12 months for arm A and B respectively Under this scenario for a sample size of at the most 150 patients the proposed design strategy has led to a simulated power of 0911 compared with a 0717 one for the Complete Randomisation design
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-004107-31 | EUDRACT_NUMBER | None | None |