This study examines if tumor tissue taken from a biopsy can be used to successfully develop micro-organospheres (MOS) in patients with breast cancer that has spread to other places in the body (advanced) or that cannot be completely removed with surgery (unresectable). Micro-organospheres are tiny versions of tumors that keep the same structure and genetic make-up of the main tumor. These micro-organospheres (tiny versions of tumors) can then be used in a laboratory to test their response to a number of possible anti-cancer drugs. If there is a drug that works well to kill the micro-organospheres, this drug might be a good option to use as an anti-cancer drug for that person. Using patient derived micro-organospheres (PDMO) may be a more personalized approach to selecting cancer drugs that might work better in treating advanced or unresectable breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04655573.
PRIMARY OBJECTIVE:
I. To determine the feasibility of generating sufficient patient derived micro-organospheres (PDMO) from a biopsy of a patient’s advanced breast cancer to determine sensitivity to the most common forms of chemotherapy used in advanced breast cancer care.
SECONDARY OBJECTIVES:
I. Develop predictive models using PDMO and clinical outcome data (objective response rate) to assess the association between chemotherapy sensitivity in PDMO and clinical outcome of the patient.
II. Develop predictive models using PDMO and clinical outcome data (progression free survival) to assess the association between chemotherapy sensitivity in PDMO and clinical outcome of the patient.
III. Perform MODEL advanced breast cancer (ABC) on PDMO and determine associations of clinical decision-making based on chemotherapy sensitivity observed from PDMO.
OUTLINE: This is an observational study.
Patients undergo tissue biopsy on study. Patients undergo computed tomography (CT) and bone scan or positron emission tomography (PET)/CT during screening. Patients’ medical records are also reviewed.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationDuke University Medical Center
Principal InvestigatorJeremy Force
