Status:
COMPLETED
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)
Lead Sponsor:
G1 Therapeutics, Inc.
Conditions:
TNBC - Triple-Negative Breast Cancer
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in...
Detailed Description
This study will have two separate cohorts (Cohort 1 and Cohort 2). Both cohorts will follow the same general study conduct/design with similar primary and key secondary endpoints and identical treatme...
Eligibility Criteria
Inclusion
- Age \>/= 18 years of age with evaluable locally advanced unresectable or metastatic TNBC.
- Documentation of triple negative breast cancer (estrogen and progesterone receptor \<1% and HER2-negative)
- Prior systemic therapies (Cohort 1 only):
- No prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, targeted therapy, immunotherapy, or investigational agents.
- Prior PD-1/PD-L1 inhibitor treatment is not permitted in any setting, including in the neoadjuvant setting.
- Time between completion of last treatment with curative intent and first metastatic recurrence must be ≥ 6 months.
- Prior systemic therapies (Cohort 2 only):
- Documentation of PD-L1 positive status
- Treated with a PD-1/PD-L1 inhibitor for a minimum duration of 4 months in the locally advanced unresectable/metastatic setting and as the most recent therapy.
- Radiation therapy for metastatic disease is permitted. There is no required minimum washout period for radiation therapy. Patients should be recovered from the effects of radiation.
- Archival tumor tissue must be available or a fresh biopsy must be obtained, unless approved by the Medical Monitor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as demonstrated by normal laboratory values
Exclusion
- Prior treatment with gemcitabine in any setting.
- Prior treatment with carboplatin in the locally advanced unresectable/metastatic setting.
- Prior carboplatin in the (neo)adjuvant/curative setting is permitted as long as it was completed ≥ 6 months prior to the first metastatic recurrence.
- Presence of central nervous system (CNS) metastases and/or leptomeningeal disease requiring immediate treatment with radiation therapy or steroids.
- Receipt of any cytotoxic chemotherapy within 14 days prior to the first dose of study drugs.
- QTcF interval \>480 msec at Screening (confirmed in triplicate). For patients with ventricular pacemakers, QTcF \>500 msec.
- Known hypersensitivity to carboplatin or other platinum-containing compounds, or mannitol
- Pregnant or lactating women
- Prior hematopoietic stem cell or bone marrow transplantation
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2024
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT04799249
Start Date
May 14 2021
End Date
May 24 2024
Last Update
August 1 2024
Active Locations (71)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner M.D. Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Washington Cancer Institute at MedStar Washington Hospital Center - Oncology Research
Washington D.C., District of Columbia, United States, 20010
3
Florida Cancer Specialists - North (SCRI)
St. Petersburg, Florida, United States, 33705
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612