A multicenter, multicohort, phase 2 platform trial to personalize second-line treatment intensity and targeting in HR-positive, HER2-negative metastatic breast cancer through an integrated liquid biopsy algorithm.

Conditions

Metastatic breast cancer

Brief summary

Clinical Benefit Rate (CBR), defined as the proportion of patients achieving a Complete response (CR) or Partial response (PR) or Stable disease (SD) lasting at least 6 months, as assessed according to RECIST 1.1 criteria

Detailed description

Progression Free Survival (PFS), defined as time from second line treatment start until progression or death for any cause, whichever comes first, OS, defined as time from second line treatment start until death from any cause, Prevalence of somatic alterations detected through plasma NGS in patients who are candidate to receiving second line therapy in HR+/HER2- MBC, Prognostic impact on PFS and OS of somatic alterations detected through plasma NGS in patients candidate to receiving second line therapy in HR+/HER2- MBC, Proportion of patients with a CTCs count ≥ 5/7.5 mL compared to those with a CTCs count <5/7.5 mL at baseline of second line therapy for HR+/HER2- MBC, Prognostic impact on PFS and OS of a CTCs count ≥ 5/7.5 mL with respect to CTCs count < 5/7.5 mL in patients candidate to receiving second line therapy in HR+/HER2- MBC

Related papers

No related papers found yet.

Interventions

DRUGFulvestrant Dr. Reddy’s 250 mg soluzione iniettabile in siringa preriempita

DRUGEnhertu 100 mg powder for concentrate for solution for infusion

DRUGCapecitabine Teva 150 mg film-coated tablets

DRUGTRUQAP 160 mg film-coated tablets

DRUGORSERDU 86 mg film-coated tablets

DRUGTRUQAP 200 mg film-coated tablets

DRUGORSERDU 345 mg film-coated tablets

DRUGCapecitabine Teva 500 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Clinical Benefit Rate (CBR), defined as the proportion of patients achieving a Complete response (CR) or Partial response (PR) or Stable disease (SD) lasting at least 6 months, as assessed according to RECIST 1.1 criteria	—

Secondary

Measure	Time frame
Progression Free Survival (PFS), defined as time from second line treatment start until progression or death for any cause, whichever comes first, OS, defined as time from second line treatment start until death from any cause, Prevalence of somatic alterations detected through plasma NGS in patients who are candidate to receiving second line therapy in HR+/HER2- MBC, Prognostic impact on PFS and OS of somatic alterations detected through plasma NGS in patients candidate to receiving second line therapy in HR+/HER2- MBC, Proportion of patients with a CTCs count ≥ 5/7.5 mL compared to those with a CTCs count <5/7.5 mL at baseline of second line therapy for HR+/HER2- MBC, Prognostic impact on PFS and OS of a CTCs count ≥ 5/7.5 mL with respect to CTCs count < 5/7.5 mL in patients candidate to receiving second line therapy in HR+/HER2- MBC	—

Measure

Time frame

Progression Free Survival (PFS), defined as time from second line treatment start until progression or death for any cause, whichever comes first, OS, defined as time from second line treatment start until death from any cause, Prevalence of somatic alterations detected through plasma NGS in patients who are candidate to receiving second line therapy in HR+/HER2- MBC, Prognostic impact on PFS and OS of somatic alterations detected through plasma NGS in patients candidate to receiving second line therapy in HR+/HER2- MBC, Proportion of patients with a CTCs count ≥ 5/7.5 mL compared to those with a CTCs count <5/7.5 mL at baseline of second line therapy for HR+/HER2- MBC, Prognostic impact on PFS and OS of a CTCs count ≥ 5/7.5 mL with respect to CTCs count < 5/7.5 mL in patients candidate to receiving second line therapy in HR+/HER2- MBC

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Outcome results

None listed