Trial · NCT05113966
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
NCT05113966, Phase 2, Terminated, G1 Therapeutics, Inc.; results first posted 2025-01-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer. Trials, record NCT05113966. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05113966
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
- NCT number
- NCT05113966
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- G1 Therapeutics, Inc.
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Trilaciclib, Sacituzumab Govitecan-hziy
- First posted
- 2021-11-09
- Last updated
- 2025-01-29
- Results first posted
- 2025-01-29
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Up to approximately 23 months | 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 |
| Secondary | Objective Response Rate (ORR) | Up to approximately 24 months | 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. |
| Secondary | Clinical Benefit Rate (CBR) | Up to approximately 24 months | 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 |
| Secondary | Duration of Objective Response (DOR) | Up to approximately 24 months | 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. |
| Secondary | Overall Survival (OS) | Up to approximately 24 months | 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). |
| Secondary | Number of Participants With Occurrence of Severe Neutropenia (SN) | Up to approximately 24 months | Occurrences of SN in Cycles 1 and 2 and the overall study are reported. |
| Secondary | Participants With At Least One Occurrence of Febrile Neutropenia (FN) | Up to approximately 24 months | 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. |
| Secondary | Occurrence of Granulocyte Colony-stimulating Factor (G-CSF) Administration | Up to approximately 24 months | 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. |
| Secondary | Occurrence of Grade 3 or 4 Decreased Hemoglobin (Hgb) | Up to approximately 24 months | 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). |
| Secondary | Number of RBC Transfusions | From Week 5 up to approximately 24 months | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | Up to approximately 23 months | FAS: included all enrolled participants who were administered at least 1 dose of study drug. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Up to approximately 24 months | The Response Evaluable (RE) population included all participants who were in the FAS and who had measurable (target) tumor lesion(s) at the baseline tumor assessment and either (i) had at least 1 post-baseline tumor assessment, or (ii) do not have post-dose tumor assessment but had clinical progression as noted by the Investigator, or (iii) died due to disease progression prior to their first post-baseline tumor scan. | percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) | Up to approximately 24 months | RE: population included all participants who were in the FAS and who had measurable (target) tumor lesion(s) at the baseline tumor assessment and either (i) had at least 1 post-baseline tumor assessment, or (ii) did not have post-dose tumor assessment but had clinical progression as noted by the Investigator, or (iii) died due to disease progression prior to their first post-baseline tumor scan. | percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Response (DOR) | Up to approximately 24 months | The Response Evaluable (RE) population included all participants who were in the FAS and who had measurable (target) tumor lesion(s) at the baseline tumor assessment and either (i) had at least 1 post-baseline tumor assessment, or (ii) did not have post-dose tumor assessment but had clinical progression as noted by the Investigator, or (iii) died due to disease progression prior to their first post-baseline tumor scan. DOR was only analyzed for the participants who had achieved OR. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 24 months | FAS: included all enrolled participants who were administered at least 1 dose of study drug. | months | MEDIAN |
| SECONDARY | Number of Participants With Occurrence of Severe Neutropenia (SN) | Up to approximately 24 months | FAS: included all enrolled participants who were administered at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With At Least One Occurrence of Febrile Neutropenia (FN) | Up to approximately 24 months | FAS: included all enrolled participants who were administered at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of Granulocyte Colony-stimulating Factor (G-CSF) Administration | Up to approximately 24 months | FAS: included all enrolled participants who were administered at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of Grade 3 or 4 Decreased Hemoglobin (Hgb) | Up to approximately 24 months | FAS: included all enrolled participants who were administered at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of RBC Transfusions | From Week 5 up to approximately 24 months | Data were not collected for this outcome measure nor conducted as part of the final analysis as they were not deemed critical for the aCSR. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Trilaciclib + Sacituzumab Govitecan-hziy | 4.1 | 95% Confidence Interval 2.2 to 7.3 | months | |
| Objective Response Rate (ORR) | Trilaciclib + Sacituzumab Govitecan-hziy | 23.3 | 95% Confidence Interval 9.9 to 42.3 | percentage of participants | |
| Clinical Benefit Rate (CBR) | Trilaciclib + Sacituzumab Govitecan-hziy | 46.7 | 95% Confidence Interval 28.3 to 65.7 | percentage of participants | |
| Duration of Objective Response (DOR) | Trilaciclib + Sacituzumab Govitecan-hziy | 8.8 | 95% Confidence Interval 4.0 to NA | months | |
| Overall Survival (OS) | Trilaciclib + Sacituzumab Govitecan-hziy | 15.9 | 95% Confidence Interval 9.9 to 20.9 | months | |
| Number of Participants With Occurrence of Severe Neutropenia (SN) | Trilaciclib + Sacituzumab Govitecan-hziy | Participants with At Least 1 Event During Cycles 1-2 / No | 29 | Participants | |
| Number of Participants With Occurrence of Severe Neutropenia (SN) | Trilaciclib + Sacituzumab Govitecan-hziy | Participants with At Least 1 Event During Cycles 1-2 / Yes | 1 | Participants | |
| Number of Participants With Occurrence of Severe Neutropenia (SN) | Trilaciclib + Sacituzumab Govitecan-hziy | Participants with At Least 1 Event During Overall Study / No | 29 | Participants | |
| Number of Participants With Occurrence of Severe Neutropenia (SN) | Trilaciclib + Sacituzumab Govitecan-hziy | Participants with At Least 1 Event During Overall Study / Yes | 1 | Participants | |
| Participants With At Least One Occurrence of Febrile Neutropenia (FN) | Trilaciclib + Sacituzumab Govitecan-hziy | No | 29 | Participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trilaciclib + Sacituzumab Govitecan-hziy | 30 | |
| Overall Study | COMPLETED | Trilaciclib + Sacituzumab Govitecan-hziy | 0 | |
| Overall Study | NOT COMPLETED | Trilaciclib + Sacituzumab Govitecan-hziy | 30 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Trilaciclib + Sacituzumab Govitecan-hziy | 16 | 30 | |
| other | Diarrhoea | Gastrointestinal disorders | Trilaciclib + Sacituzumab Govitecan-hziy | 13 | 30 | |
| other | Constipation | Gastrointestinal disorders | Trilaciclib + Sacituzumab Govitecan-hziy | 9 | 30 | |
| other | Vomiting | Gastrointestinal disorders | Trilaciclib + Sacituzumab Govitecan-hziy | 8 | 30 | |
| other | Abdominal pain | Gastrointestinal disorders | Trilaciclib + Sacituzumab Govitecan-hziy | 6 | 30 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Trilaciclib + Sacituzumab Govitecan-hziy | 3 | 30 | |
| other | Dyspepsia | Gastrointestinal disorders | Trilaciclib + Sacituzumab Govitecan-hziy | 3 | 30 | |
| other | Abdominal distension | Gastrointestinal disorders | Trilaciclib + Sacituzumab Govitecan-hziy | 2 | 30 | |
| other | Dry mouth | Gastrointestinal disorders | Trilaciclib + Sacituzumab Govitecan-hziy | 2 | 30 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Trilaciclib + Sacituzumab Govitecan-hziy | 2 | 30 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trilaciclib + Sacituzumab Govitecan-hziy | 21 | 30 |
| Total, other adverse events | Trilaciclib + Sacituzumab Govitecan-hziy | 29 | 30 |
| Total, serious adverse events | Trilaciclib + Sacituzumab Govitecan-hziy | 6 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05113966
GET https://conductscience.org/api/trials/v1/NCT05113966/events?page=2