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Summary

for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor). This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4). The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6. Approximately 250 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.

Official Title

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

Keywords

Breast Cancer Hormone-receptor positive Letrozole

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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 Arms 1, 2 and 3
  • 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.
  • 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.

You CAN'T join if...

  • 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

Locations

  • University of California at San Diego, Moores Cancer Ctr Dept. of Moores Cancer Center accepting new patients
    San Diego, California, 92103, United States
  • Northwest Medical Specialties Northwest Medical Specialties accepting new patients
    Tacoma, Washington, 98405, United States
  • Cancer Therapy & Research Center / UT Health Science Center Dept of Onc accepting new patients
    San Antonio, Texas, 78229, United States
  • Texas Oncology Texas Oncology - Sammons accepting new patients
    Dallas, Texas, 75246, United States
  • Methodist Hospital / Methodist Cancer Center Dept of Oncology accepting new patients
    Houston, Texas, 77030, United States
  • Vanderbilt University Medical Center Vanderbilt - Thompson Ln accepting new patients
    Nashville, Tennessee, 37232, United States
  • Sarah Cannon Research Institute SCRI SC accepting new patients
    Nashville, Tennessee, 37203, United States
  • H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt Cancer Center accepting new patients
    Tampa, Florida, 33612, United States
  • Dartmouth Hitchcock Medical Center SC accepting new patients
    Lebanon, New Hampshire, 03756, United States
  • Massachusetts General Hospital SC-5 accepting new patients
    Boston, Massachusetts, 02114, United States
  • Novartis Investigative Site accepting new patients
    Glasgow, G12 0YN, United Kingdom
  • Novartis Investigative Site accepting new patients
    Manchester, M20 9BX, United Kingdom
  • Novartis Investigative Site accepting new patients
    Seoul, Korea, 03080, Korea, Republic of
  • Novartis Investigative Site in progress, not accepting new patients
    Marseille, 13273, France
  • Novartis Investigative Site in progress, not accepting new patients
    Paris, 75010, France
  • Novartis Investigative Site accepting new patients
    Saint Herblain cedex, 44805, France
  • Novartis Investigative Site accepting new patients
    Sevilla, Andalucia, 41013, Spain
  • Novartis Investigative Site accepting new patients
    Valencia, Comunidad Valenciana, 46010, Spain
  • Novartis Investigative Site accepting new patients
    Madrid, 28007, Spain
  • Novartis Investigative Site accepting new patients
    Madrid, 28050, Spain
  • Novartis Investigative Site accepting new patients
    Bellinzona, 6500, Switzerland
  • Novartis Investigative Site accepting new patients
    Chur, 7000, Switzerland
  • Novartis Investigative Site accepting new patients
    Meldola, FC, 47014, Italy
  • Novartis Investigative Site accepting new patients
    Modena, MO, 41124, Italy
  • Novartis Investigative Site accepting new patients
    Pisa, PI, 56126, Italy
  • Novartis Investigative Site accepting new patients
    Torino, TO, 10126, Italy
  • Novartis Investigative Site accepting new patients
    Westmead, New South Wales, 2145, Australia
  • Novartis Investigative Site accepting new patients
    Parkville, Victoria, 3050, Australia
  • Novartis Investigative Site accepting new patients
    Nedlands, Western Australia, 6009, Australia

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT01872260
Phase
Phase 1
Lead Scientist
Pamela Munster
Study Type
Interventional
Last Updated
July 1, 2017
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