First Line Atezolizumab, Paclitaxel, and Bevacizumab (Avastin®) in mTNBC (ATRACTIB)
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|ClinicalTrials.gov Identifier: NCT04408118|
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : November 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer Advanced Breast Cancer Triple Negative Breast Cancer||Drug: Atezolizumab Drug: Paclitaxel Drug: Bevacizumab||Phase 2|
Men and women age ≥ 18 years with previously untreated unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) that is not amenable to resection with curative intent regardless of programmed death-ligand 1 (PD-L1) status.
The number of patients to be included is 100 patients. The primary objective is to evaluate the efficacy -in terms of progression-free survival (PFS)- of first line atezolizumab in combination with paclitaxel and bevacizumab (Avastin®) in patients with unresectable locally advanced or metastatic TNBC.
After signing the ICF and confirmed eligibility, patients will begin treatment on 28 days cycles: Atezolizumab (840 mg) intravenously on days 1 and 15; Paclitaxel (90 mg/m2) via IV infusion on days 1, 8 and 15; Bevacizumab (Avastin® 10mg/kg) intravenously on days 1 and 15.
Patients will receive treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason.
Patients discontinuing the study treatment will enter a post- treatment follow-up period until death, withdrawal of consent, patient is lost to follow-up, or study termination.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Trial to Evaluate the Efficacy and Safety of First Line Atezolizumab in Combination With Paclitaxel and Bevacizumab (Avastin®) in Patients With Advanced or Metastatic Triple-negative Breast Cancer|
|Actual Study Start Date :||October 5, 2020|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||April 2023|
Experimental: Atezolizumab + Paclitaxel + Bevacizumab (Avastin®)
All eligible patients will be treated with atezolizumab (840 mg) intravenously on days 1 and 15, Paclitaxel (90 mg/m2) on days 1, 8 and 15 via IV infusion and Bevacizumab (Avastin® 10mg/kg) intravenously on days 1 and 15.
Treatment cycles and patient visits are organized in scheduled cycles of 28 days.
Atezolizumab (840 mg) will be administered intravenously on Days 1 and 15.
The first infusion of atezolizumab will be administered over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.
Paclitaxel (90 mg/m2) will be administered on days 1, 8 and 15 via IV infusion over 1 hour.
Bevacizumab (Avastin® 10mg/kg) will be administered intravenously over 30-90 minutes on Days 1 and 15.
Other Name: Avastin
- PFS (Progression-free Survival) [ Time Frame: 24 months ]From a clinical point of view, the primary endpoint for this study is the PFS (progression-free survival) defined as the period of time from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1.
- Efficacy (TTR) [ Time Frame: 24 months ]TTR is defined as the time from the treatment initiation to time of the first objective tumor response (tumor shrinkage of ≥30%) observed for patients who achieved a complete response (CR) or partial response (PR).
- Efficacy (ORR) [ Time Frame: 24 months ]Objective response rate (ORR) is defined as the sum of CR and PR relative to the number of patients in the analysis set with measurable disease at baseline.
- Efficacy (CBR) [ Time Frame: 24 months ]Clinical benefit rate (CBR) is defined as the proportion of participants with CR, PR or SD ≥24 weeks relative to the number of patients in the analysis set.
- Efficacy (DoR) [ Time Frame: 24 months ]Duration of response (DoR) is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression, death due to any cause or treatment discontinuation, whichever occurs first.
- Efficacy (OS) [ Time Frame: 24 months ]Overall survival (OS) is defined as the time from date of treatment initiation to date of death due to any cause. In the absence of confirmation of death, survival time will be censored to last date the participant was known to be alive.
- Efficacy (Best percentage of change of target tumor lesions) [ Time Frame: 24 months ]Best percentage of change from baseline in the size of target tumor lesions is defined as the biggest decrease, or smallest increase if no decrease will be observed.
- Safety AEs and SAEs [ Time Frame: 24 months ]Incidence and severity of adverse events (AEs), serious adverse events (SAEs) according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0, including dose reductions, delays, and treatment discontinuations.
- Exploratory objectives (irPFS) [ Time Frame: 24 months ]Immune-related progression-free survival (irPFS) is defined as the period of time from the date of treatment initiation to the date of the first documentation of objective progression of disease (irPD) or death due to any cause in absence of documented irPD.
- Exploratory objectives (irORR) [ Time Frame: 24 months ]Immune-related objective response (irORR) is defined as the proportion of participants with irCR or irPR relative to the number of patients in the analysis set with measurable disease at baseline.
- Exploratory objectives (molecular markers) [ Time Frame: 24 months ]Changes in mutation and copy number in oncogenes, tumor suppressors, and/or other genes associated with disease progression assessed in liquid biopsy.
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): NCT04408118
|Contact: Susana Vitorino||+34656 234 firstname.lastname@example.org|
|Contact: Carolina Herrero||+34 673 973 email@example.com|
|Principal Investigator:||Antonio Llombart, PhD||MedSIR|