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Sequential Therapies for Breast Cancer

Phase < 1

Recruiting

Led By Aixa Soyano, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A negative pregnancy test for pre-menopausal women of childbearing potential

ECOG performance status 0-1

Must not have

Documented brain metastasis or active or newly diagnosed CNS metastases

Treatment with any investigational compound within 30 days prior to the first dose of study drugs or during this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new way of giving approved drugs to treat metastatic breast cancer to see if it could be more effective than the current method.

Who is the study for?

This trial is for individuals with metastatic breast cancer. Participants should be suitable to receive the study drugs, which are all approved treatments. Specific eligibility criteria were not provided, so interested individuals should contact the study team for more details.

What is being tested?

The trial is testing a new treatment strategy using existing drugs: Abemaciclib, Sacituzumab govitecan, Trastuzumab deruxtecan, Xeloda (capecitabine), Taxotere (docetaxel), Cytoxan (cyclophosphamide), Fulvestrant and Ribociclib. The goal is to see if administering these drugs sequentially based on evolutionary dynamics can improve outcomes in metastatic breast cancer.

What are the potential side effects?

Potential side effects include nausea, fatigue, hair loss from chemotherapy agents like Taxotere and Cytoxan; diarrhea and hand-foot syndrome from Xeloda; low blood cell counts from most of these medications; liver issues from Abemaciclib; allergic reactions or infusion-related symptoms from monoclonal antibodies like Trastuzumab deruxtecan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant.

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I am fully active or can carry out light work.

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My breast cancer is hormone positive and HER2 negative, confirmed by tests.

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My breast cancer is hormone positive and was treated with hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastasis or newly diagnosed CNS metastases.

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I haven't taken any experimental drugs in the last 30 days.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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My cancer has spread to vital organs and poses an immediate risk to my life.

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I have tested positive for HIV or have AIDS.

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I have had allergic reactions to similar medications in the past.

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I have been treated with Fulvestrant for my breast cancer.

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I do not have active infections like TB, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of Sequential Therapy

Secondary study objectives

No Evidence of Disease (NED)

Safety and Tolerability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sequential therapyExperimental Treatment8 Interventions

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab govitecan

2017

Completed Phase 3

~530

Trastuzumab deruxtecan

2021

Completed Phase 2

~800