CRC_WO40181

VERONICA A Phase II, Multicenter, Randomized study to compare the efficacy of Venetoclax plus Fulvestrant versus Fulvestrant in women with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer who experienced disease recurrence or progression during or after CDK4/6 inhibitor therapy.

This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, inoperable, locally advanced or MBC who experienced disease recurrence or progression during or after treatment with CDK4/6i therapy for at least 8 weeks.

Key Inclusion Criteria:

Histological or cytological confirmation of estrogen receptor-positive (ER+) invasive carcinoma of the breast. ER+, HER2- negative invasive carcinoma of the breast with evaluable sample for BCL-2 IHC value at the time of screening

Evidence of metastatic or locally advanced disease not amenable to surgical or local therapy with curative intent

Be postmenopausal
Phase II
NCT03584009
Cancer
Breast
Ajay Kundra, M.D.
Roche Holding AG (Hoffman-LaRoche)
Courtney Nichols
  • Providence Regional Cancer Partnership - Everett