Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Clinical summary
Summary
This study will have two separate cohorts, that will both follow the same general study design with identical treatment arms. Cohort 1 will evaluate participants receiving first-line therapy, regardless of programmed death-ligand 1 (PD-L1) status, who are programmed cell death protein 1 (PD-1)/PD-L1 inhibitor therapy naive. Cohort 2 will evaluate PD-L1 positive participants receiving second-line therapy following prior PD-L1/PD-L1 inhibitor therapy in the locally advanced unresectable/metastatic setting. Within each cohort, participants will be randomly assigned to either the Experimental arm or Placebo Comparator arm. In the Experimental Arm, participants will receive Trilaciclib (240mg/m2 administered intravenously [via IV] over 30 mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle), in combination with gemcitabine (1000mg/m2, administered via IV on Day 1 and Day 8 of each 21-day cycle) and carboplatin (AUC 2, administered via IV on Day 1 and Day 8 of each 21-day cycle). In the Placebo Comparator Arm, participants will receive placebo (administered via IV over 30 mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle), in addition to gemcitabine (administered via IV on Day 1 and Day 8 of each 21-day cycle) and carboplatin (administered via IV on Day 1 and Day 8 of each 21-day cycle).
Conditions
This trial is treating people with triple-negative breast cancer
Eligibility
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)
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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.
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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.
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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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
G1 Therapeutics, Inc
Scientific Title
A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)
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