G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer
Completed · Phase 1
Conditions studied: Carcinoma, Ductal, Breast, Breast Cancer Female, Breast Neoplasm, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Stage IV Breast Cancer
In brief
This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer. The study is an open-label design, consisting of 3 parts: dose-finding portion including food effect (Part 1), G1T48 monotherapy expansion portion (Part 2), and G1T48 in combination with palbociclib expansion portion (Part 3). All 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, 184 patients may be enrolled in the study.
Key facts
- Study ID
- NCT03455270
- Run by
- G1 Therapeutics, Inc.
- People needed
- 107
- Starts
- 2018-05-09
- Expected to finish
- 2022-09-29
- Last updated by the study team
- 2022-12-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
Where it is running
- Beverly Hills Cancer Center — Beverly Hills, California, United States
- Stanford Women Cancer Center — Stanford, California, United States
- Northwestern University - Feinberg School of Medicine — Chicago, Illinois, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
- Sarah Cannon Research Institute at Tennessee Oncology — Nashville, Tennessee, United States
- Institut Jules Bordet — Brussels, Belgium
- UZ Leuven — Leuven, Belgium
- MHAT for Womens Health - Nadezhda OOD — Sofia, Bulgaria
- ARENSIA Exploratory Medicine LLC — Tbilisi, Georgia
- ARENSIA Exploratory Medicine Phase I Unit, The Institute of Oncology — Chisinau, Moldova
- VU University Medical Center — Amsterdam, Netherlands
- University Medical Center Groningen — Groningen, Netherlands
- Erasmus Medical Center — Rotterdam, Netherlands
- Spizhenko Clinic — Kiev, Ukraine
Full record on ClinicalTrials.gov
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