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Triple Negative Breast CancerPhase 2NCT05113966

Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

A Phase 2 study testing Trilaciclib and Sacituzumab Govitecan-hziy in people with Triple Negative Breast Cancer, run by G1 Therapeutics, Inc. at 22 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Trilaciclib and Sacituzumab Govitecan-hziy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
22 sitesUnited States
Study dates
8 Dec 2021to 13 Jun 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Prior treatment with trilaciclib, sacituzumab govitecan-hziy, irinotecan, Trop-2 antibody drug conjugate, or any therapy with a topoisomerase-1 payload.
  • Participants with known brain metastasis at enrollment.
  • Participants with known Gilbert's disease or known homozygous for the UGT1A1*28 allele.
  • Participants with bone-only disease.
  • Malignancies other than TNBC within 3 years prior to enrollment. Participants with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death <5% at 5 years as determined by the Investigator) are eligible provided they meet all of the following criteria:
  • Malignancy treated with expected curative intent (e.g., adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent);
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  • No evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers.
  • History of clinically significant gastrointestinal bleeding, intestinal obstruction, or gastrointestinal perforation within 6 months of enrollment.
  • Receipt of any investigational medication within 4 weeks, or at least 5 half-lives, whichever is greater, prior to the first dose of study treatment.
  • Receipt of any cytotoxic chemotherapy within 2 weeks or antibody treatment for cancer within 3 weeks prior to the first dose of study treatment.
  • Receipt of any high dose systemic corticosteroids within 2 weeks prior to the first dose of study treatment.
  • Low dose corticosteroids (≤20 mg prednisone or equivalent daily) are permitted if the dose is stable for 4 weeks, or if medically indicated as part of their pre-medications for infusions.
  • Topical steroids and corticosteroid inhalers are allowed.
  • Current use of immunosuppressive medication, except for the following:
  • Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
  • Systemic corticosteroids at physiological doses ≤10 mg/day of prednisone or equivalent;
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • Use of oral or IV antibiotics within 2 weeks prior to enrollment.
  • QT corrected interval using Fridericia's formula (QTcF) >480 msec at screening (confirmed on repeat). For participants with ventricular pacemakers, QTcF >500 msec.
  • Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure (Class III or IV as defined by the New York Heart Association functional classification system).
  • History of stroke or cerebrovascular accident within 6 months prior to first dose of study treatment.
  • Known serious active infection such as, but not limited to, human immunodeficiency virus (HIV) (e.g., viral load indicative of HIV, HIV 1/2 antibodies), Hepatitis B (e.g., Hepatitis B surface antigen reactive or Hepatitis B DNA detected), Hepatitis C (e.g., Hepatitis C ribonucleic acid [quantitative] is detected) or tuberculosis.
  • Severe infection within 4 weeks prior to enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Other uncontrolled serious chronic disease or psychiatric condition that in the Investigator's opinion could affect participant safety, compliance, or follow-up in the protocol.
  • Known hypersensitivity or allergy to irinotecan, SN-38, trilaciclib, or sacituzumab govitecan-hziy or any excipients of the aforementioned medications
  • Prior hematopoietic stem cell or bone marrow transplantation.
  • Pregnant or lactating women
  • Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
  • Received a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment or anticipation that such a vaccine will be required during the study treatment period:
  • Influenza vaccination should be given during influenza season only (approximately October through May in the Northern Hemisphere).
  • Legal incapacity or limited legal capacity.
  • Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or participants who are employees of G1 Therapeutics, Inc. directly involved in the conduct of the study.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Multicare Health System

    Auburn, Washington, 98001

  • Texas Oncology - Austin Central

    Austin, Texas, 78731

  • Comprehensive Blood & Cancer Center

    Bakersfield, California, 93309

  • Ironwood Physicians

    Chandler, Arizona, 85224

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80220

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Duly Health and Care

    Joliet, Illinois, 60435

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Texas Oncology - Longview Cancer Center

    Longview, Texas, 75601

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Oncology and Hematology Associates of Southwest Virginia, Inc

    Roanoke, Virginia, 24014

  • UCLA Hematology/Oncology Parkside

    Santa Monica, California, 90404

  • New England Cancer Specialists

    Scarborough, Maine, 04704

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Northwest Cancer Specialists, PC

    Tigard, Oregon, 97223

  • PIH Health

    Whittier, California, 90602

  • Minnesota Oncology Hematology, P.A.

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

The study included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of the first dose of study treatment and was completed at the Safety Follow-up Visit. Trilaciclib and sacituzumab govitecan-hziy were administered intravenously (IV) in 21-day cycles. Study drug administration continued until progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or clinical progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the study, whichever occurred first. The first Survival Follow-up assessment occurred approximately 3 months after the Safety Follow-Up Visit and continued every 3 months until the end of the study (or death).

Being tested
Trilaciclib, Sacituzumab Govitecan-hziy
Keywords
TNBC, Trodelvy, Myelosuppression
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrilaciclibDrug

    Also called G1T28, CDK 4/6 inhibitor

    Single-use, sterile powder to be reconstituted and further diluted with 250 milliliters (mL) of normal saline (sodium chloride solution 0.9%) or dextrose 5% in water (D5W)

  • Sacituzumab Govitecan-hziyDrug

    Also called Trodelvy, IMMU-132

    10 milligram per kilogram (mg/kg) reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline

Study groups in NCT05113966
Study groupRoleWhat they receive
Trilaciclib + Sacituzumab Govitecan-hziyExperimentalParticipants 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.
Receives: Drug: Trilaciclib; Drug: Sacituzumab Govitecan-hziy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Progression free survival was defined as the time (months) from the date of the first dose of the study drug to the date of documented radiographic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: Up to approximately 23 months

Secondary outcomes (15)

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants with the best overall response of confirmed complete response or confirmed partial response per RECIST v1.1 Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Up to approximately 24 months

  2. Clinical Benefit Rate (CBR)

    CBR was defined as the percentage of participants with the best overall response of confirmed complete response, confirmed partial response, or stable disease lasting 24 weeks or longer since the first date of study drug administration per RECIST v1.1

    Measured: Up to approximately 24 months

  3. Duration of Objective Response (DOR)

    DOR was the time between the first objective response of CR or PR (confirmed) and the first date that progressive disease was documented or death, whichever comes first. DOR was only analyzed for the patients who had achieved objective responses.

    Measured: Up to approximately 24 months

  4. Overall Survival (OS)

    OS was defined as the time (months) from the date of the first dose of the study drug to the date of death for participants who died in the study due to any cause or the time to the last contact date known to be alive for those participants who survived as of the data cutoff date for the planned OS analysis (censored cases).

    Measured: Up to approximately 24 months

  5. Number of Participants With Occurrence of Severe Neutropenia (SN)

    Occurrences of SN in Cycles 1 and 2 and the overall study are reported.

    Measured: Up to approximately 24 months

  6. Participants With At Least One Occurrence of Febrile Neutropenia (FN)

    FN was defined as a complication of cancer treatment. It is the development of a fever, alongside other signs of infection such as feeling unwell, shivers, and shakes in a participant with neutropenia.

    Measured: Up to approximately 24 months

  7. Occurrence of Granulocyte Colony-stimulating Factor (G-CSF) Administration

    The number of cycles with G-CSF administrations for a participant was the total number of cycles where the participant received at least one dose of G-CSF, for participants who did not have any G-CSF use and those who were enrolled but did not receive any study treatment, a value of 0 was assigned.

    Measured: Up to approximately 24 months

  8. Occurrence of Grade 3 or 4 Decreased Hemoglobin (Hgb)

    The occurrence of Grade 3 or 4 decreased hemoglobin (Hgb) for a participant was defined as having at least one Hgb value that was < 8.0 gram per deciliter (g/dL) among all scheduled or unscheduled assessments. It was a binary random variable (Yes or No).

    Measured: Up to approximately 24 months

  9. Number of RBC Transfusions

    Based on the NCCN Clinical Practice Guidelines in Oncology for Hematopoietic Growth Factors Version 2.2020 and the AABB Clinical Practice Guidelines, the following RBC transfusion thresholds were recommended; however, the participant's clinical situation should always be the primary guiding factor when deciding to transfuse.

    • Transfusion is not indicated until the hemoglobin level is ≤7 g/dL for hospitalized adult hemodynamically stable participants .
    • An RBC transfusion threshold of ≤8 g/dL is recommended for participants undergoing orthopedic surgery, cardiac surgery, and those with preexisting cardiovascular disease.

    Measured: From Week 5 up to approximately 24 months

  10. Number of Participants With Occurrence of Erythropoiesis-Stimulating Agent (ESA) Administration

    If participants experienced chemotherapy-induced anemia (hemoglobin level <10 g/dL) after receiving the first dose of study treatment, ESAs may be used per ASCO guidelines to improve hematopoietic response and reduce the likelihood of RBC transfusion.

    Measured: Up to approximately 24 months

  11. Number of Participants With Occurrence of Grade 3 and 4 Decrease of Platelets

    Grade 3 shows signs of mucosal bleeding, such as blood crusting in nostrils or nosebleeds, petechiae or purpura in the mouth, blood in the urine or stool, and heavy periods. Grade 4 shows signs of more severe mucosal bleeding or suspected internal bleeding, such as in the brain or lungs that requires immediate medical attention.

    Measured: Up to approximately 24 months

  12. Number of Platelet Transfusions

    Platelet transfusion is recommended at a threshold of ≤10 x 10^9/L. Platelets should also be transfused in any participant who was bleeding with a platelet count <50 x 10^9/L (100 x 10^9/L for central nervous system or ocular bleeding).

    Measured: Up to approximately 24 months

  13. Number of Participants With Occurrence of Serious Infections

    Participants experienced chemotherapy-induced myelosuppression faced severe clinical consequences such as serious infections are reported.

    Measured: Up to approximately 24 months

  14. Number of Participants Administered IV Antibiotics

    Measured: Up to approximately 24 months

  15. Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Non-serious Adverse Events (NSAEs)

    AEs are defined as those events occurring or worsening after treatment has begun in the study. An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: From first administration of study treatment (Day 1) up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2021
  2. Study start8 Dec 2021
  3. Primary completion10 Nov 2023
  4. Study completion13 Jun 2024

Why it stopped: The Sponsor decided to close enrollment to the study on Feb 14, 2023, in order to reallocate resources to other ongoing trilaciclib clinical trials.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05113966
Sponsor's protocol ID
G1T28-213
Status last verified
Nov 2024
First submitted
18 Oct 2021
Last updated
29 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trilaciclib and Sacituzumab Govitecan-hziy in people with Triple Negative Breast Cancer, run by G1 Therapeutics, Inc. at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to approximately 23 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05113966.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.

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