Status:
TERMINATED
Pharmacodynamic Biomarkers of Standard Anti-microtubule Drugs as Assessed by Early Tumor Biopsy
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Breast Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
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 phy...
Detailed Description
During the screening visit, the following will be taken: medical history; physical exam; ECOG performance status; a pregnancy test if indicated per physician (confirmation of the clinical testing resu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 11 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03393741
Start Date
January 29 2018
End Date
February 11 2024
Last Update
June 25 2024
Active Locations (1)
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1
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792