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, Advanced Breast Cancer

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, Advanced Breast Cancer

ClinicalTrials.gov Identifier: NCT02333370

Novartis Reference Number: CLEE011A2115C

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of the Phase Ib is to:

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
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
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.

Condition 
Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
Phase 
Phase 1
Overall status 
Active, not recruiting
Enrollment count 
88 participants
Start date 
Feb 04, 2015
Completion date 
Oct 26, 2020
Gender 
Female
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
LEE011
LEE011 as 50 mg and 200 mg hard gelatin oral capsules as individual patient supply packaged in bottles. LEE011 will be taken QD - days 1-21 of each 28 days cycle.
Drug
Letrozole
25mg
Drug
Tamoxifen
20 mg
Drug
Fulvestrant
500 mg
Drug
goserelin

Eligibility 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

Study Locations

Hong Kong
Novartis Investigative Site
-
Hong Kong,
-
Hong Kong
Japan
Novartis Investigative Site
-
Nagoya-city, 467-8602
Aichi
Japan
Novartis Investigative Site
-
Sapporo-city, 003-0804
Hokkaido
Japan
Novartis Investigative Site
-
Yokohama-city, 241-8515
Kanagawa
Japan
Novartis Investigative Site
-
Osaka-city, 540-0006
Osaka
Japan
Novartis Investigative Site
-
Suita city, 565 0871
Osaka
Japan
Novartis Investigative Site
-
Hidaka-city, 350-1298
Saitama
Japan
Novartis Investigative Site
-
Kitaadachi-gun, 362-0806
Saitama
Japan
Novartis Investigative Site
-
Sunto Gun, 411 8777
Shizuoka
Japan
Novartis Investigative Site
-
Bunkyo ku, 113-8431
Tokyo
Japan
Novartis Investigative Site
-
Bunkyo ku, 113-8677
Tokyo
Japan
Novartis Investigative Site
-
Koto ku, 135 8550
Tokyo
Japan
Novartis Investigative Site
-
Shinagawa-ku, 142-8666
Tokyo
Japan
Novartis Investigative Site
-
Shinjuku-ku, 160-0023
Tokyo
Japan
Singapore
Novartis Investigative Site
-
Singapore, 169610
-
Singapore

Have a question?

Call 1-999-669-6682 or email [email protected]