Ignite Creation Date:
2024-05-06 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05266937
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2020-02-10
Brief Title:
Atezolizumab Plus CArboplatin Plus Nab-paclitaxel
Sponsor:
Consorzio Oncotech
Organization:
Consorzio Oncotech
Study Overview
Official Title:
A Phase II Trial of Atezolizumab Plus CArboplatin Plus Nab-paclitaxel as First-line Therapy in Metastatic Triple-negative PD-L1 Positive Breast Cancer Patients - the GIM25-CAPT Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
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:
None
Brief Summary:
Primary objective
To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients as evaluated by 2years OS
Secondary objective
To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients in terms of OS at 25 years
To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients in terms of OS at 2 years in hormonal receptor HR between 1 and 10
To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients in terms of post-progression survival
To assess the activity of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients in terms of ORR and time to treatment failure
To assess the safety of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients
Exploratory Objectives
Exploratory objectives will be focused on the assessment of both tumor-centered characteristics through the NGS analysis of circulating tumor DNA ctDNA and immune-centric features through the evaluation of a multiparametric Cancer agnostic circuLating ImmunOsignature CLIO
To assess the association between patients characteristics treatment activity efficacy and safety and through a CLIO in metastatic triple-negative breast cancer patients receiving atezolizumab plus carboplatin plus paclitaxel as first-line therapy
To explore the association between the CLIO and treatment activity efficacy and safety
To explore the dynamics of circulating tumor DNA ctDNA levels and detectable aberrations with respect to treatment activity and efficacy Concomitant timepoints will not be used for cross-validations between the two methodologies
To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients as evaluated by 2years OS
Secondary objective
To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients in terms of OS at 25 years
To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients in terms of OS at 2 years in hormonal receptor HR between 1 and 10
To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients in terms of post-progression survival
To assess the activity of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients in terms of ORR and time to treatment failure
To assess the safety of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients
Exploratory Objectives
Exploratory objectives will be focused on the assessment of both tumor-centered characteristics through the NGS analysis of circulating tumor DNA ctDNA and immune-centric features through the evaluation of a multiparametric Cancer agnostic circuLating ImmunOsignature CLIO
To assess the association between patients characteristics treatment activity efficacy and safety and through a CLIO in metastatic triple-negative breast cancer patients receiving atezolizumab plus carboplatin plus paclitaxel as first-line therapy
To explore the association between the CLIO and treatment activity efficacy and safety
To explore the dynamics of circulating tumor DNA ctDNA levels and detectable aberrations with respect to treatment activity and efficacy Concomitant timepoints will not be used for cross-validations between the two methodologies
Detailed Description:
All eligible patients will receive carboplatin Area Under the Curve AUC 2 dd 1815 q 28 dd paclitaxel 90 mgm2 dd 1815 q 28 dd and atezolizumab 840 mg dd 115 q 28 dd and they will continue this treatment until progression of disease unacceptable toxicity death withdrawal of consent loss to follow-up or study termination by the Sponsor In case of interruption of one of the three drugs for unacceptable toxicity andor medical decision the patient may continue to receive one or more of the remaining drugs until progression per RECIST v11
If the investigator decides to interrupt carboplatin and paclitaxel for toxicity andor medical decision atezolizumab may be continued as maintenance therapy until disease progression or unacceptable toxicity
All patients who discontinue study treatment including due to PD will be followed for survival approximately every 3 months for 2 years from last patient enrolled or until death withdrawal of consent loss to follow-up or study termination by the Sponsor
Imaging tumor evaluation will be performed every 12 weeks
If the investigator decides to interrupt carboplatin and paclitaxel for toxicity andor medical decision atezolizumab may be continued as maintenance therapy until disease progression or unacceptable toxicity
All patients who discontinue study treatment including due to PD will be followed for survival approximately every 3 months for 2 years from last patient enrolled or until death withdrawal of consent loss to follow-up or study termination by the Sponsor
Imaging tumor evaluation will be performed every 12 weeks
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