Table 2.
Key upcoming phase II/III/IV clinical trials combining CDK4/6 inhibitors with fulvestrant
| Study name (ClinicalTrials.gov identifier) | Study arms | Study population | Outcomes measures |
|---|---|---|---|
| PADMA (NCT03355157) | Palbociclib + endocrine therapy vs chemotherapy with/without endocrine maintenance | Patients with metastatic HR+/HER2− BC in a real‐world setting | TTF |
| PEARL (NCT02028507) | Palbociclib + exemestane or fulvestrant vs capecitabine | Females with histologically confirmed metastatic BC whose disease is resistant to previous nonsteroidal AIs (letrozole or anastrozole) (on or within 12 months after end of adjuvant or within 1 month after end of endocrine treatment) | PFS and ORR |
| MAINTAIN (NCT02632045) | Ribociclib + fulvestrant vs fulvestrant + placebo | Patients with histologically or cytologically confirmed adenocarcinoma of the breast with unresectable or metastatic disease | PFS and ORR |
| PASIPHAE (NCT03322215) | Palbociclib + fulvestrant vs capecitabine | Patients with metastatic HR+/HER2− BC with progressive disease after endocrine treatment (on or within 12 months after end of adjuvant or within 1 month after end of endocrine treatment) | PFS, HRQOL, OS, and CBR |
| SONIA (NCT03425838) | AI + CDK4/6 (palbociclib/ribociclib) as first‐line therapy, followed by fulvestrant as second‐line therapy vs AI as first‐line therapy, followed by fulvestrant + CDK4/6 inhibitors in second‐line therapy | Women with HR+/HER2− advanced BC, who received prior treatment with an AI either as (neo)‐adjuvant or for advanced disease | PFS, OS, QOL, and ORR |
| PARSIFAL (NCT02491983) | Palbociclib + letrozole vs Palbociclib + fulvestrant | Aged ≥18 years or older, postmenopausal women with metastatic or locally advanced disease HR+/HER2− BC, not amenable to curative therapy. No prior chemotherapy line in the metastatic setting | PFS, TTP, OS,CBR, and ORR |
AI, aromatase inhibitor; BC, breast cancer; CDK, cyclin dependent kinases; CBR, clinical benefit rate; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; HRQOL, health related quality of life; OS, overall survival; ORR, overall response rate; PFS, progression‐free survival; QOL, quality of life; TTF, time to treatment failure; TTP, time to progression.