A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive Metastatic Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
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
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 inst…
Interventions
- DrugTaxotere
75 mg/m2 once every 21 days for 4 cycles
- DrugCytoxan
600 mg/m2 once every 21 days for 4 cycles
- DrugTrastuzumab deruxtecan
5.4 mg/kg once every 21 days for 5 cycles
- DrugSacituzumab govitecan
10 mg/kg on days 1 and 8 cycled every 21 days for 5 cycles
- DrugXeloda
1000 mg/m2 orally twice daily for 14 days cycled every 21 days for 5 cycles
- DrugFulvestrant
500 mg intramuscular (IM) on days 1, 15 and 28 of the first cycle followed by every 28 days for a total of 4 cycles
- DrugRibociclib
Location
- Moffitt Cancer CenterTampa, Florida