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Protocol No. UW16073

Principal Investigator Wisinski, Kari

Phase II

Age Group Adult

Scope National

Sponsor Type Institutional

Title Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women with Er-Positive, HER2-negative Early Breast Cancer

Objective The purpose of this study is to find out if the study drug called "ribociclib" when taken with the already FDA-approved drug called "letrozole" before surgery is more effective than letrozole alone, and ultimately decreases the number of women that require chemotherapy after surgery.

Treatment Ribociclib is an experimental drug, which means it has not been approved by the US Food and Drug Administration (FDA) for the treatment of women with breast cancer. Ribociclib is an orally bioavailable highly selective small molecule inhibitor of CDK4/6. Several lines of evidence suggest that increased CDK4/6 activity contributes to tumorgenesis. Agents that inhibit the activity of CDK4/6 may be able to slow or stop the proliferation of these cancers and thereby function as effective anti-cancer drugs.

Description There are three treatment groups in the study. You will be assigned in a random fashion to one of the three groups. A computer will decide which group you are in. Group A will receive letrozole for 28 days plus a placebo every 4 weeks for 6 cycles. Group B will receive letrozole for 28 days plus the study drug ribociclib for 21 days every 4 weeks for 6 cycles. Group C will receive letrozole for 28 days plus the study drug ribociclib for 28 days every 4 weeks for 6 cycles. For all three study groups, the study treatment will be taken by mouth.

Key Eligibility
  • Female subjects, age ≥ 18 years
  • Only postmenopausal women will be eligible defined by bilateral surgical oophorectomy, no spontaneous menses > 1 year or no menses for < 1 year with FSH and estradiol levels in postmenopausal range, according to institutional standards
  • Invasive breast cancer must be ER+ in ≥66 % of the cells or ER Allred score 6-8
  • Invasive breast cancer must be HER2 negative
  • Patients with ductal carcinoma in situ in either breast are eligible
  • Patients with ipsilateral multifocal/multi-centric invasive breast cancer are eligible
  • Subject must agree to provide the required research biopsies at baseline, at day 14 (+7 d) and at surgery for biomarker and correlative studies
  • Patients with inflammatory breast cancer are excluded
  • Patients with contralateral invasive breast cancer are excluded
  • Patients with clinical or radiographic evidence of metastatic disease are excluded
  • Patients with a known history of HIV infection are excluded
  • Patients who are currently receiving warfarin or other coumarin-derived anticoagulant are excluded
  • Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed

Applicable Disease Sites Breast

Drugs Involved LEE011 (ribociclib); femara (letrozole); letrozole; ribociclib

Status Open

Participating Institutions UW Hospital and Clinics