RecruitingPhase 2

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

Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years
  • Procedures mentioned: Questionnaires, Blood draws, CT scans, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Evaluate patient related outcomes by measuring quality of life and global health status of patients on AT using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 questionnaire EORTC QLQ C-30."
  • "Patients undergo blood sample collection every cycle and computed tomography (CT) every other cycle for disease response assessment."
  • "Additionally, patients undergo blood sample collection, CT or magnetic resonance imaging (MRI), and bone scan if indicated on study."
  • "After completion of study treatment, patients are followed up every 3 months for up to 3 years from time of registration."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests capecitabine, a cancer drug, for adults with breast cancer that has spread to other parts of the body. The cancer must use estrogen to grow (ER positive) and be HER2 negative. Researchers use scans and blood tests to adjust the dose and see how the cancer responds.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with confirmed ER-positive, HER2-negative breast cancer that has spread.
  • Have cancer that can be measured on scans. Cancer only in bones must also have a measurable area in nearby soft tissue.
  • Plan to start capecitabine within 14 days, or have started within the past 42 days with no more than two treatment cycles.
  • Be able to care for yourself and be up and about for at least half of your waking hours.
  • Meet blood count, liver, and kidney test limits. Have no blood transfusion within 14 days before joining.
  • Have a negative pregnancy test within 7 days before joining, if you could become pregnant.
  • Sign a consent form, complete surveys with or without help, give research blood samples, have required CT scans, and return for follow-up visits.
  • For group 2, scans after starting capecitabine must show that the cancer has stayed the same, shrunk, or disappeared. If already treated, the first CT scan must be within 28 days of the first dose.

Who can't join

  • Past chemotherapy or antibody-linked cancer drug treatment for cancer that has spread. Group 2 may have had up to two cycles of capecitabine.
  • Pregnant, breastfeeding, or able to become pregnant but unwilling to use birth control.
  • Major surgery within 3 weeks or radiation within 2 weeks before joining.
  • Cancer causing a severe organ crisis, threatening to press on the spinal cord, or uncontrolled cancer in the brain that needs treatment.
  • Uncontrolled illness, such as infection, serious heart or breathing problems, or mental health or social problems that prevent study participation. A heart attack within 6 months also rules you out.
  • Taking another experimental drug for this cancer, or certain treatments for a past cancer. Another active cancer within 3 years also rules you out, except certain skin cancers or early cancer limited to the cervix lining.
  • Known inherited DPYD gene changes that cause a complete lack of DPD activity, which helps the body break down this drug.
  • Past severe allergic reaction to fluorouracil or capecitabine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * PRE-REGISTRATION: Provide written informed consent Note: Pre-registration should occur prior to screening research blood draws being completed * PRE-REGISTRATION: Provider anticipates the patient will begin on capecitabine within 14 days or has started capecitabine within the past 42 days and has had a maximum of two cycles Note: Pre-registration should occur prior to screening research blood draws being completed REGISTRATION - INCLUSION CRITERIA * 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) * Calculated creatinine clearance ≥ 30 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 * Ability to undergo re-staging CT scans as required by the protocol * Note: for patients who have had up to two cycles of capecitabine prior to joining the study, they must have had their initial CT imaging completed within 28 days of their first dose of capecitabine * Willing to return to enrolling institution at the specified frequency for follow-up (during the active monitoring phase of the study) * Cohort 2 only: Stable disease, partial or complete response on imaging after beginning capecitabine Exclusion Criteria: * Prior chemotherapy or use of antibody drug conjugate in the metastatic setting * Note - Cohort 2 only: Patients can have had up to two cycles of capecitabine before joining the study * 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 * chronic oxygen dependence * respiratory failure * or psychiatric illness/social situations that would limit compliance with study requirements * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Other active malignancy ≤ 3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix * If there is a history of prior malignancy, they must not be receiving other cancer specific treatment. Except for antiestrogen treatment (aromatase inhibitors or selective estrogen modulators) for their cancer are permitted if they meet other eligibility criteria. Denosumab and zoledronic acid, are permitted as established adjunct therapies per guidelines * History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Patients known to have certain homozygous or compound heterozygous dihydropyrimidine dehydrogenase (DPYD) variants that result in complete absence of deoxypyridinoline (DPD) activity. Test results do not need to be available prior to registration * History of severe hypersensitivity reactions to fluorouracil or capecitabine

Study sites (1)

AZ