Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

NCT06409390 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-22617
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of Sequential Therapy

  The proportion of patients able to complete the sequence of therapies by the conclusion of the trial.

  Up to 18 months

Secondary Outcomes (2)

• Safety and Tolerability

  Up to 18 months

• No Evidence of Disease (NED)

  Up to 18 months

Study Arms (1)

Sequential therapy

EXPERIMENTAL

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)

Drug: Taxotere; Drug: Cytoxan; Drug: Trastuzumab deruxtecan; Drug: Sacituzumab govitecan; Drug: Xeloda; Drug: Fulvestrant; Drug: Ribociclib; Drug: Abemaciclib

Interventions

Sacituzumab govitecan DRUG

10 mg/kg on days 1 and 8 cycled every 21 days for 5 cycles

Also known as: Trodelvy

Sequential therapy

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

Also known as: Faslodex

Sequential therapy

Ribociclib DRUG

600 mg orally daily 21 days on, 7 days off

Also known as: Kisqali

Sequential therapy

Abemaciclib DRUG

150 mg by mouth twice daily

Also known as: Verzenio

Sequential therapy

Taxotere DRUG

75 mg/m2 once every 21 days for 4 cycles

Also known as: Docetaxel

Sequential therapy

Cytoxan DRUG

600 mg/m2 once every 21 days for 4 cycles

Also known as: Cyclophosphamide

Sequential therapy

Trastuzumab deruxtecan DRUG

5.4 mg/kg once every 21 days for 5 cycles

Also known as: Enhertu

Sequential therapy

Xeloda DRUG

1000 mg/m2 orally twice daily for 14 days cycled every 21 days for 5 cycles

Also known as: Capecitabine

Sequential therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Cyclophosphamide; trastuzumab deruxtecan; sacituzumab govitecan; Capecitabine; Fulvestrant; ribociclib; abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Aixa Soyano, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luza Herrera Dominguez

CONTACT

813-745-5332; Luza.Herrera@moffitt.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)