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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-04

Study Completion Date

2022-09-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

LEE011 + Fulvestrant

LEE011 - 3 weeks on 1 week off Fulvestrant 500 mg - Dosed every 28 days (Day 1 for each cycle) with 1 additional dose on Day 15 of Cycle 1

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

500 mg

Interventions

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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.

Intervention Type DRUG

Letrozole

25mg

Intervention Type DRUG

Tamoxifen

20 mg

Intervention Type DRUG

Fulvestrant

500 mg

Intervention Type DRUG

goserelin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No