Overview

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