Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

Trial Title: Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

NCT ID: NCT06409390

Condition: Metastatic Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Cyclophosphamide
Docetaxel
Capecitabine
Trastuzumab
Fulvestrant
Sacituzumab govitecan
Trastuzumab deruxtecan

Study type: Interventional

Study phase: Early Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Taxotere
Description: 75 mg/m2 once every 21 days for 4 cycles
Arm group label: Sequential therapy

Other name: Docetaxel

Intervention type: Drug
Intervention name: Cytoxan
Description: 600 mg/m2 once every 21 days for 4 cycles
Arm group label: Sequential therapy

Other name: Cyclophosphamide

Intervention type: Drug
Intervention name: Trastuzumab deruxtecan
Description: 5.4 mg/kg once every 21 days for 5 cycles
Arm group label: Sequential therapy

Other name: Enhertu

Intervention type: Drug
Intervention name: Sacituzumab govitecan
Description: 10 mg/kg on days 1 and 8 cycled every 21 days for 5 cycles
Arm group label: Sequential therapy

Other name: Trodelvy

Intervention type: Drug
Intervention name: Xeloda
Description: 1000 mg/m2 orally twice daily for 14 days cycled every 21 days for 5 cycles
Arm group label: Sequential therapy

Other name: Capecitabine

Intervention type: Drug
Intervention name: Fulvestrant
Description: 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
Arm group label: Sequential therapy

Other name: Faslodex

Intervention type: Drug
Intervention name: Ribociclib
Description: 600 mg orally daily 21 days on, 7 days off
Arm group label: Sequential therapy

Other name: Kisqali

Intervention type: Drug
Intervention name: Abemaciclib
Description: 150 mg by mouth twice daily
Arm group label: Sequential therapy

Other name: Verzenio

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.

Criteria for eligibility:
Criteria:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Moffitt Cancer Center

Address:
City: Tampa
Zip: 33612
Country: United States

Status: Recruiting

Contact:
Last name: Jennifer Childress

Phone: 813-745-0578

Investigator:
Last name: Aixa Soyano, MD
Email: Principal Investigator

Investigator:
Last name: Dana Ataya, MD
Email: Sub-Investigator

Start date: April 26, 2024

Completion date: April 2027

Lead sponsor:
Agency: H. Lee Moffitt Cancer Center and Research Institute
Agency class: Other

Source: H. Lee Moffitt Cancer Center and Research Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06409390