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Clinical Trial VICCBREP1363


A Phase Ib/II, Multicenter, Study of the Combination of LEE011 and BYL719 with Letrozole in Adult Patients with Advanced ER+ Breast Cancer

Principal Investigator(s)

Ingrid Mayer


  • Protocol No. VICCBREP1363
  • Open Date: 03/21/2014
  • Staging: Phase I/II
  • Age Group: Adults
  • Scope: National
  • Objective: Phase Ib: To estimate the MTD and/or RP2D of the following three combinations in patients with ER+/HER2-advanced breast cancer: 1. LEE011 and letrozole (doublet) 2. BYL719 and letrozole (doublet) 3. LEE011, BYL719 and letrozole (triplet) Phase II: To assess the anti-tumor activity: 1. The combination of LEE011, BYL719 and letrozole compared to the combination of LEE011 and letrozole in patients with ER+/HER2- advanced breast cancer. 2. The combination of LEE011, BYL719 and letrozole compared to the combination of BYL719 and letrozole in patients with ER+/HER2- advanced breast cancer.
  • Disease Sites: None Specified
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01872260
  • Secondary Protocol No: CLEE011X2107


The reason for the study is to learn whether LEE011and/or BYL719, when added to an approved treatment (letrozole) for the patient's type of advanced breast cancer, helps to stabilize or stop progression of breast cancer.


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Postmenopausal, Estrogen-receptor positive and/or Progesterone-receptor positive breast cancer
• Phase Ib dose escalation only: Any number of prior lines of endocrine therapy is allowed with the exception of cytotoxic therapy which is limited to one prior line administered in the advanced (metastatic or locally advanced) setting.
• Phase Ib dose expansions: No prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole for a maximum of one month prior to starting study treatment.
• Phase Ib dose expansions: Patients who received (neo)adjuvant therapy for breast cancer are eligible. Prior therapy with letrozole or anastrozole in the (neo)adjuvant setting is permitted if the disease free interval is greater than 12 months from the completion of treatment.
Exclusion Criteria:
• HER2-overexpression in the patient's tumor tissue
• Patients with active CNS or other brain metastases
• Major surgery within 2 weeks
• Acute or chronic pancreatitis
• Bilateral diffuse lymphangitic carcinomatosis
• Another malignancy within 3 years
• Receiving hormone replacement therapy that cannot be discontinued
• Impaired cardiac function
• Patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose ≥ 126 mg/dL / 7.0 mmol/L or hemoglobin A1c >6.5%), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus.
• Other protocol-defined inclusion/exclusion criteria may apply