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Keep this study
Lead
G1 Therapeutics, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
