Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Qamar Khan
With
Novartis Pharmaceuticals
Subjects will be randomized (1:1:1) to either letrozole plus placebo vs. letrozole plus continuous dosing of ribociclib vs. letrozole plus intermittent dosing (3-weeks-on/1-week-off) of ribociclib.
The difference in clinical, pathologic and radiologic response as well as Pre-operative Endocrine Prognostic Index (PEPI) scores across the three treatments arms will be examined. Subjects will also be followed for 5 years post-treatment to determine if ribociclib in combination with letrozole for 24 weeks results in improved 5 year Relapse Free Survival (RFS) compared to letrozole alone.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Pathologically confirmed invasive breast cancer by core needle biopsy
Female subjects, age ≥ 18 years
Only postmenopausal women will be eligible.
Performance Status: Eastern Cooperative Oncology Group (ECOG) score 0-2
Invasive breast cancer must be ER+ in ≥66 % of the cells or ER Allred score 6-8
Invasive breast cancer must be HER2 negative.
Clinical Stage II or III (by clinical measurement and/or breast imaging)
You may not be if
Current use of other investigational agents
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
An excisional biopsy of this breast cancer
Surgical axillary staging procedure prior to study entry
Hormone replacement therapy of any type, megestrol acetate, or raloxifene within four weeks prior to first study treatment
Clinical or radiographic evidence of metastatic disease
