Breast Cancer Clinical Trial
Official title:
Pharmacodynamic Biomarkers of Standard Anti-microtubule Drugs as Assessed by Early Tumor Biopsy
Eligible subjects will be assigned to study treatment arms by their treating oncologist, rather than by the study. The drug, dose, and schedule of administration will be determined by the treating physician per NCCN guidelines for standard of care chemotherapy regimens for recurrent or metastatic breast cancer. Study treatment arms include: Taxane (nab-paclitaxel or paclitaxel), Eribulin, Vinorelbine, Ixabepilone, or the control arm (non-microtubule targeted chemotherapies such as doxorubicin, carboplatin, or gemcitabine).
Status | Recruiting |
Enrollment | 35 |
Est. completion date | August 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men and women with histologically or cytologically demonstrated breast cancer that is deemed metastatic or incurable by the treating physician. - It is medically appropriate to treat the patient with an antimitotic agent or an intravenous control chemotherapeutic agent by IV infusion at standard doses as per the treating physician. Please see NCCN guidelines for standard of care, p58 for standard chemotherapy regimens for recurrent or metastatic breast cancer7. - The patient has measureable disease as determined by RECIST 1.1. - Archived tissue is available from either primary, metastatic site or both. - It is safe and feasible to obtain a research tumor biopsy on cycle 1 day 2 with a biopsy of an accessible lesion such as liver, lung, lymph node, skin, breast, or bone. - All pre-chemotherapy test results (tests per treating oncologist discretion) have been reviewed and deemed appropriate for planned chemotherapy by the patient's treating oncologist. Exclusion Criteria: - HER2+ breast cancer by standard criteria. - Pregnant women are excluded from this study because systemic chemotherapy may cause deleterious effects to the fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with systemic chemotherapy, breastfeeding should be discontinued if the mother is enrolled in the trial. - Planned treatment with hormonal therapy, or targeted oral therapy during trial enrollment. |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of measuring biomarkers in advanced breast tumors at 20 +/- 2 hours after chemotherapy | Advanced breast tumors safely sampled and analyzed from 35 subjects. In order to successfully test the hypothesis that chromosomal instability in part governs the effect of antimitotic therapies, advanced breast tumors samples must be collected, preserved, and analyzed at 20+/- 2 hours after chemotherapy in order to characterize the effect of the drug on the tumor. A primary question becomes is this process safe and feasible within these time constraints in our clinical setting. |
Up to 22 hours | |
Secondary | Measure intratumoral drug levels at 20 +/- 2 hours after chemotherapy | Tumor tissue and plasma samples taken at 20 hours will be assessed for drug levels by the University of Wisconsin 3P Lab. | Up to 22 hours | |
Secondary | Measure serum drug levels at 20 +/- 2 hours after chemotherapy | Tumor tissue and plasma samples taken at 20 hours will be assessed for drug levels by the University of Wisconsin 3P Lab. | Up to 22 hours | |
Secondary | Measure PBMC pharmacodynamics at 20 +/- 2 hours after chemotherapy | Tumor tissue and plasma samples taken at 20 hours will be assessed for drug levels by the University of Wisconsin 3P Lab. | Up to 22 hours | |
Secondary | Assess effects of mitosis and DNA damage response at 20 +/- 2 hours after chemotherapy | Mitotic index will be analyzed by fluorescence in situ hybridization, immunofluorescence, immunohistochemistry, and liquid chromatography and ctDNA | Up to 22 hours | |
Secondary | Correlate drug levels and cellular effects with response by RECIST 1:1 to chemotherapy | Summary statistics will be used to describe drug levels and cellular effects by response to chemotherapy | Up to 2 months following completion of study treatment OR upon the systemic imaging following therapy completion (whichever is later) | |
Secondary | Assess genomic profile of metastatic breast cancer | This sequencing is measured to understand how changes in treatment response correlate to genomic profile. | Up to 2 months following completion of study treatment OR upon the systemic imaging following therapy completion (whichever is later) | |
Secondary | Feasibility of quantifying circulating tumor DNA (ctDNA) 20 +/- 2 hours after administration of chemotherapy. | This measurement is taken to understand if changes in ctDNA over the stated interval can be correlated to the treatment response and genomic profile from the 35 subjects. | Up to 2 months following completion of study treatment OR upon the systemic imaging following therapy completion (whichever is later) | |
Secondary | Explore differences in progression free survival (PFS) between chemotherapy arms. | PFS will be analyzed using the Kaplan-Meier method and measured from C1D1 until documented progression on imaging scan or death. Patients who do not experience documented progression during the study and are alive at last follow-up will be censored on the date of last imaging scan. Small sample statistical methods will be used to compare PFS curves by chemotherapy arm. | Up to 2 months following completion of study treatment OR upon the systemic imaging following therapy completion (whichever is later) | |
Secondary | Explore differences in response rate (RR) between chemotherapy arms. | Response rate (RR) will be summarized by chemotherapy arm including 95% confidence intervals. | Up to 2 months following completion of study treatment OR upon the systemic imaging following therapy completion (whichever is later) |
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