A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advance

• Status: Active, not recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the Phase Ib is to:

1. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in Asian non-Japanese patients

2. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and activity data in Japanese patients

3. evaluate the safety and anti-tumor activity of LEE011 at the RP2D established in the dose escalation part in combination with a standard dose of letrozole, fulvestrant or tamoxifen plus goserelin in Japanese patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Estradiol; Fulvestrant; Goserelin; Hormones; Letrozole; Tamoxifen

Criteria

Inclusion Criteria:

• Women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy (surgery and/or radiotherapy).

• Patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer

• Patient has HER2-negative breast cancer

• Patient has adequate bone marrow and organ function

Exclusion Criteria:

• Patient who received any CDK4/6 inhibitor.

• Patient has a known hypersensitivity to any of the excipients of LEE011 or letrozole

• Patients with inflammatory breast cancer.

• Patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer

• Patient is currently using other anti-cancer therapy

• Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.

• Patient who has received radiotherapy ≤ 4 weeks

• Patient has a concurrent malignancy or malignancy within 3 years

• Patient has metastases to the central nervous system (CNS).

• Patient has a known history of HIV infection

Other protocol-defined inclusion/exclusion criteria may apply