Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer
NCT06409390 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-12-04
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
Interventions
- 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
-
5.4 mg/kg once every 21 days for 5 cycles
- DRUG
-
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
-
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
-
600 mg orally daily 21 days on, 7 days off
- DRUG
-
150 mg by mouth twice daily
Sponsors & Collaborators
-
H. Lee Moffitt Cancer Center and Research Institute
lead OTHER
Principal Investigators
-
Aixa Soyano, MD · Moffitt Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-14
- Primary Completion
- 2027-04-30
- Completion
- 2027-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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