RecruitingPhase 2NCT06409390

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


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

15 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a strategy of rotating between different hormone-based therapies for metastatic breast cancer that is hormone-receptor positive and HER2 negative. The idea is to use cancer's evolutionary patterns against it — switching therapies to prevent resistance from developing. **You may be eligible if...** - You are a woman 18 or older - You have metastatic breast cancer that is hormone receptor-positive and HER2 negative, confirmed by biopsy - Your cancer has been previously treated with hormone therapy (aromatase inhibitor or Tamoxifen, with or without a CDK4/6 inhibitor) - You have elevated breast tumor markers (CA 15-3 or similar) **You may NOT be eligible if...** - Your breast cancer is HER2 positive - You have not previously received hormone therapy - You have severe organ damage from prior treatments - You have brain metastases requiring immediate treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

600 mg orally daily 21 days on, 7 days off

DRUGAbemaciclib

150 mg by mouth twice daily


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

View Full Details on ClinicalTrials.gov

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NCT06409390


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