Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06409390
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 14, 2024
Status verified
Dec 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Sequential therapy
    In this study sequential therapies will be administered. Strike 1: Cytoxan/Taxotere/GM-CSF Strike 2: Sacituzumab govitecan or trastuzumab deruxtecan Strike 3: Capecitabine Strike 4: Fulvestrant + CDK 4/6 inhibitor (ribociclib or abemaciclib)

Primary Outcome Measure

Feasibility of Sequential Therapy [ Time Frame: Up to 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Aixa Soyano, MD (PRINCIPAL_INVESTIGATOR)
Dana Ataya, MD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Moffitt Cancer Center· Tampa, FL

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