Status:
ACTIVE_NOT_RECRUITING
Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-100 years
Phase:
PHASE1
PHASE2
Brief 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 m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2027
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT01872260
Start Date
October 22 2013
End Date
February 26 2027
Last Update
October 29 2025
Active Locations (25)
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1
Univ of California at San Diego Moores Cancer Ctr
San Diego, California, United States, 92103
2
UCSF Medical Center
San Francisco, California, United States, 94143
3
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
4
Massachusetts General Hospital SC-5
Boston, Massachusetts, United States, 02114