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Recruiting Phase 2 NCT06409390

Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

Trial Parameters

Condition Metastatic Breast Cancer
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 15
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-08-14
Completion 2027-04
Interventions
TaxotereCytoxanTrastuzumab deruxtecan

Brief Summary

The purpose of the study is to test a treatment strategy with currently approved drugs to see if it is practical to administer the available drugs in a new way that researchers hope could be more effective in treating metastatic breast cancer.

Eligibility Criteria

Inclusion Criteria: * Female patients 18 years or older * Histologically or cytologically confirmed diagnosis of hormone positive HER2 negative metastatic breast cancer per ASCO/CAP criteria (Allison et al, 2020, Wolff et al, 2018), with diagnosis established through either a breast/axillary biopsy or biopsy of a metastatic lesion. * Hormone positive MBC previously treated with endocrine therapy with either an aromatase inhibitor or Tamoxifen (alone or in combination with a CDK4/6 inhibitor). * Elevated breast tumor markers which may include cancer antigen 15-3 (CA 15-3) levels above the institutional upper limit of normal (ULN) range of 0.0-31.0 U/mL, cancer antigen 27-29 (CA 27-29) (range \<38 U/mL) and/or elevated Carcinoembryonic antigen (CEA) above institutional upper limit of normal (range 0.0 - 5.2 ng/mL). * Presence of measurable disease on imaging via RECIST v1.1. * ECOG performance status 0-1. * Participants must have adequate organ and marrow function as defined in the proto

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