The purpose of this study is to evaluate use of lovastatin, a drug that may lower CAV-1 levels, in order to increase HER2 expression on cells and enhance the uptake and efficacy of trastuzumab deruxtecan (T-DXd) in HER2-low and ultralow advanced metastatic breast cancer. Trastuzumab deruxtecan (T-DXd) is an FDA approved antibody drug conjugate for HER2-low and ultralow breast cancer and lovastatin is a cholesterol lowering agent.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Standard of care trastuzumab deruxtecan is administered at a starting dose of 5.4 mg/kg intravenously every 3 weeks according to package guidelines. The first infusion is administered over 90 minutes, and subsequent infusions may be administered over 30 minutes if prior infusions were well tolerated.
Lovastatin is provided in 10 mg and 20mg tablets for oral administration. It will be taken approximately 12 hours and 10 minutes before each T-DXd cycle.
Washington University School of Medicine
St Louis, Missouri, United States
Objective Response Rate (ORR)
ORR is defined as the proportion of patients who achieve complete response (CR) or partial response (PR) according to RECIST v1.1. CR is defined as disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Start of treatment through end of treatment (estimated total time 12 months)
Progression Free Survival (PFS)
PFS is defined from treatment start date to date of progression or date of death due to any cause or date of last follow up, whichever is earlier. PFS will be analyzed by the Kaplan-Meier method. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Time frame: Start of treatment to date of progression, death, or date of last follow up whichever is earlier (total estimated time to be 24 months)
Overall Survival (OS)
OS is defined from start of treatment to date of death due to any cause or last date of follow up. OS will be analyzed by the Kaplan-Meier method.
Time frame: Start of treatment to date of progression, death, or date of last follow up (total estimated time to be 24 months)
Safety lead-in only: Rate of unacceptable toxicities
Unacceptable toxicities are assessed according to CTCAE v6.0 and specified in study protocol.
Time frame: Start of treatment to completion of Cycle 2 (each cycle is 3 weeks in length, estimated total time 6 weeks)
Number and type of adverse events (AEs)
AEs assessed according to CTCAE v6.0.
Time frame: Start of treatment through 30 days post last dose of either study treatment, whichever is later (estimated total time 13 months)
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