Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer

NCT06525766 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MC230303NCI-2024-0618423-009851
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 negative breast cancer.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8; Estrogen-receptor-positive Breast Cancer; Metastatic HER2-Negative Breast Carcinoma; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Ability to achieve adaptive therapy (AT)

  Will be assessed by the proportion of patients (%) who are able to receive 2 or more cycles of AT with capecitabine divided by the total number of patients who have entered the AT phase of treatment (have stable or responsive disease).

  Up to 5 years

Secondary Outcomes (5)

• Time to progression

  At registration to disease progression up to 5 years

• Overall survival (OS)

  At registration to death up to 5 years

• Cumulative dose

  Up to 5 years

• Incidence of adverse events (AEs)

  Up to 30 days after last dose of study drug

• Quality of life - EORTC-QLQ-C30

  Up to 5 years

Study Arms (1)

Treatment (capecitabine)

EXPERIMENTAL

See Detailed Description.

Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Capecitabine; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (capecitabine)

Bone Scan PROCEDURE

Undergo bone scan

Also known as: Bone Scintigraphy

Treatment (capecitabine)

Capecitabine DRUG

Given PO

Also known as: Ro 09-1978/000, Xeloda

Treatment (capecitabine)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (capecitabine)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (capecitabine)

Questionnaire Administration OTHER

Ancillary studies

Treatment (capecitabine)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Histological confirmation of estrogen-receptor positive (ER+), HER2-negative overexpression or amplification negative as per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, metastatic breast cancer
• Measurable disease. Bone only disease allowed if associated with soft tissue component that is measurable by Response Evaluation Criteria is Solid Tumors (RECIST) 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Hemoglobin ≥ 9.0 g/dL (obtained ≤ 14 days prior to registration), no transfusions allowed ≤ 14 days prior to registration
• Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 14 days prior to registration)
• Platelet count ≥ 100,000/mm\^3 (obtained ≤ 14 days prior to registration)
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)
• Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained ≤ 14 days prior to registration)
• Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)
• Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Provide written informed consent
• Ability to complete questionnaire(s) by themselves or with assistance
• Willingness to provide mandatory blood specimens for correlative research

You may not qualify if:

• Prior chemotherapy or use of antibody drug conjugate in the metastatic setting
• Any of the following, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential who are unwilling to employ adequate contraception
• Any of the following prior therapies:
• Major surgery ≤ 3 weeks prior to registration
• Radiation therapy ≤ 2 weeks prior to registration
• Evidence of visceral crisis or impending cord compression
• Evidence of uncontrolled brain metastasis requiring whole brain irradiation or intervention
• Uncontrolled intercurrent illness including, but not limited to:
• ongoing or active infection
• symptomatic congestive heart failure
• unstable angina pectoris
• uncontrolled cardiac arrhythmia

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Specimen Handling; Capecitabine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Lida A. Mina, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

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

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 15, 2030
• Study Completion (Estimated): October 15, 2030
• Last Updated: October 3, 2025

Record last verified: 2025-10

Locations

US (1)