Recruiting
Phase 2

Breast Cancer

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT06409390

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Taxotere

Cytoxan

Trastuzumab deruxtecan

Sacituzumab govitecan

Xeloda

Study Details

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

Study ID

NCT06409390

Start date

Aug 14, 2024

Status verified date

Dec, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Inclusion of minorities: patients of all races and ethnic groups who meet the above inclusion and below exclusion criteria are eligible for this trial.
  • 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 Criteria:

  • 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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sequential therapy

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)

Interventions

Taxotere

75 mg/m2 once every 21 days for 4 cycles

Cytoxan

600 mg/m2 once every 21 days for 4 cycles

Trastuzumab deruxtecan

5.4 mg/kg once every 21 days for 5 cycles

Sacituzumab govitecan

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

Xeloda

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

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

Ribociclib

600 mg orally daily 21 days on, 7 days off

Abemaciclib

150 mg by mouth twice daily

Primary outcome measure

  • Feasibility of Sequential Therapy [ Time Frame: Up to 18 months ]

Central Contacts and Locations

Central contacts

Luza Herrera Dominguez

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

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Aixa Soyano, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2025-12-04.