Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
G1 Therapeutics, Inc.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
For Part 1, postmenopausal women only
For Parts 2 and 3, any menopausal status
Confirmed diagnosis of ER-positive, HER2-negative advanced breast cancer, not amenable to curative therapy
For Part 1, prior treatment with less than 4 prior lines of chemotherapy
For Part 2, prior treatment with less than 2 prior line of chemotherapy
For Part 3, prior treatment with no more than 1 prior line of chemotherapy
For Parts 1 and 2, prior treatment with less than 4 prior endocrine therapies for metastatic breast cancer
For Part 3, prior treatment with no more than 1 prior line of endocrine therapies for metastatic breast cancer
For Parts 1 and 2, 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
* Progressed after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer
For Part 3, patients must satisfy 1 of the following criteria for prior therapy:
* Received ≥ 24 months of endocrine therapy in the adjuvant setting prior to recurrence or progression
* Received ≥ 6 months of endocrine therapy in the advanced/metastatic setting prior to progression
For Part 1, evaluable or measurable disease
For Parts 2 and 3, evaluable (approximately 25%) or measurable disease (approximately 75%) as defined by RECIST, Version 1.1 including bone-only disease
ECOG performance status 0 to 1
Adequate organ function
You may not be if
For Part 3, prior treatment with CDK4/6 inhibitor, investigational oral SERDs or SERCAs in any setting
Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
Anticancer therapy within 14 days of first G1T48 dose or within 28 days for antibody-based therapy
Concurrent radiotherapy, radiotherapy within 14 days of first G1T48 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 | G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer
