Sequential Therapies for Metastatic Breast Cancer
This study is exploring a new way to give existing approved drugs to treat metastatic breast cancer (cancer that has spread to other parts of the body). Researchers want to see if giving these drugs in a specific order is practical and potentially more effective. The drugs being tested are Taxotere, Cytoxan, Trastuzumab deruxtecan, Sacituzumab govitecan, and Xeloda. You may be able to join if you are a woman aged 18 or older with hormone-positive, HER2-negative metastatic breast cancer. The study is looking at how practical this treatment approach is over 18 months. The current status of this study is unclear, and it plans to enroll 15 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 15 women.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess the feasibility of the treatment approach for up to 18 months.
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NCT06409390
Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentH. Lee Moffitt Cancer Center and Research InstituteInvestigator-initiated
~15 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:TaxotereCytoxanTrastuzumab deruxtecanSacituzumab govitecanXelodaFulvestrant
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Sequential Therapy
Measured over Up to 18 months
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Aixa Soyano, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Female patients 18 years or older
Histologically or cytologically confirmed diagnosis of hormone positive HER2 negative metastatic breast cancer per ASCO/CAP criteria (Allison et al, 2020, Wolff et al, 2018), with diagnosis established through either a breast/axillary biopsy or biopsy of a metastatic lesion.
Hormone positive MBC previously treated with endocrine therapy with either an aromatase inhibitor or Tamoxifen (alone or in combination with a CDK4/6 inhibitor).
Elevated breast tumor markers which may include cancer antigen 15-3 (CA 15-3) levels above the institutional upper limit of normal (ULN) range of 0.0-31.0 U/mL, cancer antigen 27-29 (CA 27-29) (range \<38 U/mL) and/or elevated Carcinoembryonic antigen (CEA) above institutional upper limit of normal (range 0.0 - 5.2 ng/mL).
Presence of measurable disease on imaging via RECIST v1.1.
ECOG performance status 0-1.
Participants must have adequate organ and marrow function as defined in the protocol.
A negative pregnancy test for pre-menopausal women of childbearing potential.
Pre-menopausal women of childbearing potential who are sexually active with a male partner must agree to use adequate contraception prior to the study, for the duration of study participation.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the participant's behalf.
Exclusion
Have previously received Fulvestrant for treatment of their breast cancer.
History of allergic reactions attributed to the study drugs.
Documented brain metastasis or active or newly diagnosed CNS metastases, including meningeal carcinomatosis, because systemic treatment would need to be paused for these patients.
Treatment with any investigational compound within 30 days prior to the first dose of study drugs or during this study.
Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Uncontrolled intercurrent illness including-but not limited to-ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis.
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen \[HBsAg\]), or hepatitis C (HCV). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Participants with positive HCV antibody are eligible if polymerase chain reaction is negative for HCV RNA.
Concurrent or prior use of immunosuppressive medication within 14 days before the first dose of study drugs, with the following exceptions: premedication with dexamethasone, intranasal, inhaled, topical or local steroid injections, systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent; steroids as premedication for hypersensitivity reactions (e.g., premedication for iodinated contrast allergy before CT scan).
Inability to comply with protocol requirements.
Pregnant and/or breastfeeding women are excluded.
What this trial measures
- Feasibility of Sequential TherapyUp to 18 months
The proportion of patients able to complete the sequence of therapies by the conclusion of the trial.