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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Prior chemotherapy or use of antibody drug conjugate in the metastatic setting

Pregnant persons

Nursing persons

Persons of childbearing potential who are unwilling to employ adequate contraception

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Scan
  • Capecitabine
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Questionnaire Administration

Treatment groups

35 Participants
are divided into 1 treatment group

Sponsors and collaborators