NCT06409390

Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Taxotere	75 mg/m2 once every 21 days for 4 cycles
DRUG	Cytoxan	600 mg/m2 once every 21 days for 4 cycles
DRUG	Trastuzumab deruxtecan	5.4 mg/kg once every 21 days for 5 cycles
DRUG	Sacituzumab govitecan	10 mg/kg on days 1 and 8 cycled every 21 days for 5 cycles
DRUG	Xeloda	1000 mg/m2 orally twice daily for 14 days cycled every 21 days for 5 cycles
DRUG	Fulvestrant	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
DRUG	Ribociclib	600 mg orally daily 21 days on, 7 days off
DRUG	Abemaciclib	150 mg by mouth twice daily

Timeline

• Start date: 2024-08-14
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-05-10
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study