G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic 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

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2023-10-31

Brief Summary

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This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive, HER2-negative metastatic breast cancer.

The study is an open-label design, consists of 2 parts: dose-finding portion (Part 1), and expansion portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 102 patients will be enrolled in the study.

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Detailed Description

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Conditions

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Carcinoma, Ductal, Breast Breast Cancer Breast Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Once-Daily G1T38 Dosing

G1T38 (lerociclib) orally (once daily) in combination with fulvestrant.

Group Type EXPERIMENTAL

G1T38

Intervention Type DRUG

Fulvestrant

Intervention Type DRUG

Twice-Daily G1T38 Dosing

G1T38 (lerociclib) orally (twice daily) in combination with fulvestrant.

Group Type EXPERIMENTAL

G1T38

Intervention Type DRUG

Fulvestrant

Intervention Type DRUG

Interventions

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G1T38

Intervention Type DRUG

Fulvestrant

Intervention Type DRUG

Other Intervention Names

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lerociclib Faslodex

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of HR-positive, HER2-negative breast cancer, not amenable to curative therapy
* Pre- or perimenopausal women can be enrolled if amenable to be treated with goserelin
* Patients must satisfy 1 of the following criteria for prior therapy:

* Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor or tamoxifen
* Progressed during treatment or within 2 months after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer, or prior endocrine therapy for advanced/metastatic breast cancer
* Received ≤ 2 chemotherapy regimens (Part 1) or ≤ 1 chemotherapy regimen (Part 2) for advanced/metastatic disease
* For Part 1, evaluable or measurable disease (bone only disease eligible for Part 1 only)
* For Part 2, measurable disease as defined by RECIST, Version 1.1
* ECOG performance status 0 to 1
* Adequate organ function

Exclusion Criteria

* For Part 1, prior treatment with fulvestrant
* For Part 2, prior treatment with any CDK inhibitor or fulvestrant
* Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
* Chemotherapy within 21 days of first G1T38 dose
* Investigational drug within 28 days of first G1T38 dose
* Concurrent radiotherapy, radiotherapy within 14 days of first G1T38 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to \> 25% of bone marrow
* Prior hematopoietic stem cell or bone marrow transplantation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No