Triple Negative Breast CancerPhase 2NCT05112536
Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer
A Phase 2 study testing Trilaciclib, Cylophosphamide and Doxorubicin in people with Triple Negative Breast Cancer and Breast Cancer, run by G1 Therapeutics, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the mechanism of action, as well as the safety and efficacy of trilaciclib in combination with standard of care treatment in the neoadjuvant setting of early-stage triple negative breast cancer (TNBC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer, Breast Cancer
- What is being tested?
- Trilaciclib, Cylophosphamide and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Mar 2022to 13 Mar 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suitability of therapy and patient intends to undergo curative surgery
- Documented diagnosis of estrogen receptor (ER)-negative and progesterone receptor (PR)-negative tumor
- Primary tumor ≥ 1.5 cm with any nodal status
- Provide archival tissue for the baseline tissue sample
- ECOG performance status of 0 or 1
- Demonstrates adequate organ function
- Research tumor biopsies including at least one on-treatment biopsy (and additional biopsy at baseline, if required)
- Participants of child bearing potential must be willing to use 2 forms of contraception during the study and for 6 months following study treatment
Who cannot join
- Prior systemic therapies or radiation for current breast cancer
- History of invasive malignancy ≤3 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- History of breast cancer including ipsilateral ductal carcinoma in situ (DCIS) treated with radiotherapy at any time
- Previous exposure to doxorubicin of more than 200 mg/m2 (as lifetime exposure to doxorubicin is not to exceed 450 mg/m2)
- For patients who will receive pembrolizumab:
- History of active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is not considered a form of systemic treatment
Show all 16Show fewer
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drugs
- History of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Known history of active tuberculosis (Bacillus Tuberculosis)
- History of severe hepatic impairment
- Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure (Class II-IV as defined by the New York Heart Association [NYHA] functional classification system)
- Known history of stroke, cerebrovascular accident, severe/unstable angina, myocardial infarction, or coronary angioplasty/stenting/bypass grafting within 6 months prior to enrollment
- Known serious active infection (e.g., human immunodeficiency virus [HIV], hepatitis B or C, tuberculosis).
- Women who are pregnant or breastfeeding
- Participation in other studies involving active treatment with investigational drug(s)
- Prior hematopoietic stem cell or bone marrow transplantation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 27710
Nebraska Hematology-Oncology, P.C.
Lincoln, Nebraska, 68506
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
Virginia Oncology Associates
Norfolk, Virginia, 23502
UCLA Department of Medicine - Hematology/Oncology
Santa Monica, California, 90404
PIH Health
Whittier, California, 90602
About this study
Official title: A Phase 2, Open-Label, Single-Arm Study of Single-Dose Lead-In and Neoadjuvant Trilaciclib and Chemotherapy in Patients With Early-Stage Triple Negative Breast Cancer (TNBC)
The purpose of this study is to evaluate the mechanism of action, as well as the safety and efficacy of trilaciclib in combination with standard of care treatment in the neoadjuvant setting of early-stage triple negative breast cancer (TNBC).
This study will have four phases: 1) Screening Phase, 2) Trilaciclib Lead-In Phase, 3) Treatment Phase, and 4) Surgery and Follow-Up Phase. After a screening phase of up to 21 day, each participant will receive trilaciclib single-dose monotherapy during the lead-in phase, followed by a tumor biopsy. During the treatment phase, each participant will receive trilaciclib with standard of care chemotherapy. Immunotherapy may be included during the treatment phase, per standard of care. 3-5 weeks following conclusion of the treatment phase, each participant will undergo definitive surgery. A 30-day Safety Follow-up Visit will occur 30 days after the last dose of trilaciclib and an End of Study Visit will occur within 14 days after definitive surgery.
- Conditions
- Triple Negative Breast Cancer, Breast Cancer
- Being tested
- Trilaciclib, Cylophosphamide, Doxorubicin, Paclitaxel, Carboplatin (Investigator discretion)
- Keywords
- Breast Cancer, Triple Negative Breast Cancer, CDK4/6 Inhibitor, trilaciclib dihydrochloride, Cosela, Immuno-oncology, Solid tumor, Chemotherapy-induced myelosuppression, Myeloprotective, Cyclin-dependent kinase 4/6 inhibitor, Neoadjuvant, HER2-negative, TNBC, Breast cancer surgery, Trilaciclib, Myeloprotection, pembrolizumab, carboplatin, doxorubicin, cyclophosphamide
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrilaciclibDrug
Also called COSELA®, G1T28
Trilaciclib is administered IV as monotherapy during the lead-in phase and administered prior to chemotherapy on each day chemotherapy is administered during the treatment phase.
CylophosphamideDrug
Also called CYTOXAN®
Cyclophosphamide administered IV every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.
DoxorubicinDrug
Also called ADRIAMYCIN®
Doxorubicin administered as an IV bolus every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.
PaclitaxelDrug
Also called TAXOL®
Paclitaxel administered weekly for the last 12 cycles (cycles 5-16), each cycle 1 week in length.
Carboplatin (Investigator discretion)Drug
Also called PARAPLATIN®
Carboplatin, if given, is administered IV weekly at the start of paclitaxel administration, for the last 12 cycles (cycles 5-16).
Pembrolizumab (Investigator discretion)Biological
Also called KEYTRUDA®
Pembrolizumab, if given, is administered IV every 6 weeks throughout the treatment phase (cycles 1, 4, 9, 15).
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib plus chemotherapy | Experimental | Trilaciclib lead-in, followed by trilaciclib plus anthracycline/cyclophosphamide, then trilaciclib plus taxane chemotherapy:
* Lead-in trilaciclib (240mg/m2) single dose monotherapy
* Trilaciclib (240mg/m2) + doxorubicin (60 mg/m2) + cyclophosphamide (600 mg/m2) + pembrolizumab (per Investigator discretion; 400mg)
* Trilaciclib (240mg/m2) + paclitaxel (80 mg/m2) + carboplatin (per Investigator discretion; AUC 1.5) Receives: Drug: Trilaciclib; Drug: Cylophosphamide; Drug: Doxorubicin; Drug: Paclitaxel; Drug: Carboplatin (Investigator discretion); Biological: Pembrolizumab (Investigator discretion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune-based Mechanism of Action
Evaluated 7 days after a single-dose of trilaciclib, measured by the change in CD8+ T cells/regulatory T cells (Treg) ratio in tumor tissue; post-trilaciclib ratio minus pre-trilaciclib ratio.
Research shows a correlation between immune cells, (tumor-infiltrating lymphocytes - TILs), and favorable outcomes. Both the presence of effector CD8+ T cells and the ratio of effector CD8+ T cells to immune-suppressive regulatory T cells (Treg) correlate with improved outcome and long-term survival in solid cancers. Therefore, the higher the ratio of CD8+ T cells/Tregs, the better the predicted outcome for a patient. This outcome measure is completed by looking at tumor tissue under a microscope.
Measured: Up to 8 days after lead-in trilaciclib dose
Secondary outcomes (2)
Pathologic Complete Response (pCR) Rate
Rate of pCR using the definition of ypT0/Tis ypN0 (i.e., no invasive residual tumor in breast or nodes; noninvasive breast residuals allowed) as assessed by the local pathologist.
Measured: Up to 26 weeks
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety/tolerability as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start3 Mar 2022
- Primary completion31 Oct 2022
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- G1 Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112536
- Sponsor's protocol ID
- G1T28-212
- Status last verified
- Dec 2023
- First submitted
- 6 Oct 2021
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Single-Arm Study of Single-Dose Lead-In and Neoadjuvant Trilaciclib and Chemotherapy in Patients With Early-Stage Triple Negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT05112536
- Acronym / sponsor ID
- G1T28-212
- Conditions
- Triple Negative Breast Cancer, Breast Cancer
- Keywords
- Breast Cancer, Triple Negative Breast Cancer, CDK4/6 Inhibitor, trilaciclib dihydrochloride, Cosela, Immuno-oncology, Solid tumor, Chemotherapy-induced myelosuppression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- G1 Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the mechanism of action, as well as the safety and efficacy of trilaciclib in combination with standard of care treatment in the neoadjuvant setting of early-stage triple negative breast cancer (TNBC).
This study will have four phases: 1) Screening Phase, 2) Trilaciclib Lead-In Phase, 3) Treatment Phase, and 4) Surgery and Follow-Up Phase. After a screening phase of up to 21 day, each participant will receive trilaciclib single-dose monotherapy during the lead-in phase, followed by a tumor biopsy. During the treatment phase, each participant will receive trilaciclib with standard of care chemotherapy. Immunotherapy may be included during the treatment phase, per standard of care. 3-5 weeks following conclusion of the treatment phase, each participant will undergo definitive surgery. A 30-day Safety Follow-up Visit will occur 30 days after the last dose of trilaciclib and an End of Study Visit will occur within 14 days after definitive surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib plus chemotherapy | Experimental | Drug: Trilaciclib, Drug: Cylophosphamide, Drug: Doxorubicin, Drug: Paclitaxel, Drug: Carboplatin (Investigator discretion), Biological: Pembrolizumab (Investigator discretion)Trilaciclib lead-in, followed by trilaciclib plus anthracycline/cyclophosphamide, then trilaciclib plus taxane chemotherapy: * Lead-in trilaciclib (240mg/m2) single dose monotherapy * Trilaciclib (240mg/m2) + doxorubicin (60 mg/m2) + cyclophosphamide (600 mg/m2) + pembrolizumab (per Investigator discretion; 400mg) * Trilaciclib (240mg/m2) + paclitaxel (80 mg/m2) + carboplatin (per Investigator discretion; AUC 1.5) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Suitability of therapy and patient intends to undergo curative surgery
- Documented diagnosis of estrogen receptor (ER)-negative and progesterone receptor (PR)-negative tumor
- Primary tumor ≥ 1.5 cm with any nodal status
- Provide archival tissue for the baseline tissue sample
- ECOG performance status of 0 or 1
Key exclusion criteria (16 listed)
- Prior systemic therapies or radiation for current breast cancer
- History of invasive malignancy ≤3 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- History of breast cancer including ipsilateral ductal carcinoma in situ (DCIS) treated with radiotherapy at any time
- Previous exposure to doxorubicin of more than 200 mg/m2 (as lifetime exposure to doxorubicin is not to exceed 450 mg/m2)
- For patients who will receive pembrolizumab:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrilaciclibAlso: COSELA®, G1T28Trilaciclib is administered IV as monotherapy during the lead-in phase and administered prior to chemotherapy on each day chemotherapy is administered during the treatment phase. | Drug | Trilaciclib plus chemotherapy |
| CylophosphamideAlso: CYTOXAN®Cyclophosphamide administered IV every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length. | Drug | Trilaciclib plus chemotherapy |
| DoxorubicinAlso: ADRIAMYCIN®Doxorubicin administered as an IV bolus every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length. | Drug | Trilaciclib plus chemotherapy |
| PaclitaxelAlso: TAXOL®Paclitaxel administered weekly for the last 12 cycles (cycles 5-16), each cycle 1 week in length. | Drug | Trilaciclib plus chemotherapy |
| Carboplatin (Investigator discretion)Also: PARAPLATIN®Carboplatin, if given, is administered IV weekly at the start of paclitaxel administration, for the last 12 cycles (cycles 5-16). | Drug | Trilaciclib plus chemotherapy |
| Pembrolizumab (Investigator discretion)Also: KEYTRUDA®Pembrolizumab, if given, is administered IV every 6 weeks throughout the treatment phase (cycles 1, 4, 9, 15). | Biological | Trilaciclib plus chemotherapy |
Primary outcome
Immune-based Mechanism of Action
Time frame: Up to 8 days after lead-in trilaciclib dose
Evaluated 7 days after a single-dose of trilaciclib, measured by the change in CD8+ T cells/regulatory T cells (Treg) ratio in tumor tissue; post-trilaciclib ratio minus pre-trilaciclib ratio. Research shows a correlation between immune cells, (tumor-infiltrating lymphocytes - TILs), and favorable outcomes. Both the presence of effector CD8+ T cells and the ratio of effector CD8+ T cells to immune-suppressive regulatory T cells (Treg) correlate with improved outcome and long-term survival in solid cancers. Therefore, the higher the ratio of CD8+ T cells/Tregs, the better the predicted outcome for a patient. This outcome measure is completed by looking at tumor tissue under a microscope.
2 secondary outcomes
Pathologic Complete Response (pCR) Rate
Time frame: Up to 26 weeks
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Up to 28 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trilaciclib, Cylophosphamide and Doxorubicin in people with Triple Negative Breast Cancer and Breast Cancer, run by G1 Therapeutics, Inc. at 7 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 12 Mar 2024). 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?
Immune-based Mechanism of Action (time frame: Up to 8 days after lead-in trilaciclib dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.