A Phase 2, Single-Arm, Open-Label Study of Trilaciclib Administered Prior to Sacituzumab Govitecan-hziy in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments, at Least One in the Metastatic Setting

Who is this study for? Patients with unresectable, locally advanced or metastatic triple-negative breast cancer
What treatments are being studied? Trilaciclib+Sacituzumab Govitecan-hziy
Status: Terminated
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This was a Phase 2, multicenter, open-label, single-arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in participants with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who received at least 2 prior treatments, at least 1 in the metastatic setting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult ( ≥18 years of age), female or male participant with measurable (per RECIST v1.1), unresectable locally advanced or metastatic TNBC

• Documentation of histologically or cytologically confirmed ER-negative, PR-negative, and HER2-negative tumor per the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (ASCO/CAP) criteria.

• Measurable disease as defined by RECIST v1.1.

• Considered to be eligible to receive sacituzumab govitecan-hziy treatment, in the Investigator's judgment.

• Participants must have received 2 or more prior lines of systemic therapy, at least one of them in the metastatic setting.

• Radiation therapy for metastatic disease is permitted as long as the participant has at least 1 measurable lesion that has not been irradiated. Participants should be sufficiently recovered from the effects of radiation as determined by the Investigator but must have completed radiotherapy at least 2 weeks prior to enrollment.

• ECOG performance status of 0 or 1.

• Adequate organ function as demonstrated by the following laboratory values:

‣ Hemoglobin ≥9.0 g/dL

⁃ Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L;

⁃ Platelet count ≥100 × 10\^9/L;

⁃ Estimated glomerular filtration rate ≥30 mL/minute/1.73 m\^2;

⁃ Total bilirubin ≤1.5 × upper limit of normal (ULN);

⁃ ALT and AST ≤3 × ULN in the absence of liver metastasis or ≤5 × ULN in the presence of liver metastasis.

• Resolution of nonhematologic toxicities from prior systemic therapy, radiation therapy, or surgical procedures to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1 (except alopecia or peripheral neuropathy that may be Grade 2 or less).

⁃ Predicted life expectancy of ≥3 months.

⁃ Contraceptive use by men or women should be consistent with local guidelines regarding the methods of contraception for those participating in clinical studies.

⁃ Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.

Locations
United States
Arizona
Ironwood Physicians
Chandler
California
Comprehensive Blood & Cancer Center
Bakersfield
Los Angeles Hematology Oncology Medical Group
Los Angeles
Valkyrie Clinical Trials
Los Angeles
UCLA Hematology/Oncology Parkside
Santa Monica
PIH Health
Whittier
Colorado
Rocky Mountain Cancer Centers
Denver
Florida
Memorial Healthcare System
Hollywood
Orlando Health Cancer Institute
Orlando
Illinois
Duly Health and Care
Joliet
Maine
New England Cancer Specialists
Scarborough
Minnesota
Minnesota Oncology Hematology, P.A.
Woodbury
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
Oregon
Northwest Cancer Specialists, PC
Tigard
Texas
Texas Oncology - Austin Central
Austin
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas
Texas Oncology - Longview Cancer Center
Longview
Virginia
Inova Schar Cancer Institute
Fairfax
Virginia Oncology Associates
Norfolk
Oncology and Hematology Associates of Southwest Virginia, Inc
Roanoke
Washington
Multicare Health System
Auburn
Northwest Medical Specialties, PLLC
Tacoma
Time Frame
Start Date: 2021-12-08
Completion Date: 2024-06-13
Participants
Target number of participants: 30
Treatments
Experimental: Trilaciclib + Sacituzumab Govitecan-hziy
Participants received trilaciclib + sacituzumab govitecan-hziy on days 1 \& 8 of a 21 day cycle. Trilaciclib is administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion to be completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Related Therapeutic Areas
Sponsors
Leads: G1 Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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