Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

NCT06409390 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-04

No results posted yet for this study

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

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06409390 on ClinicalTrials.gov