Is NCT06525766 recruiting in Scottsdale, AZ?

Yes, NCT06525766 is currently recruiting participants at its Scottsdale, AZ location. This anatomic stage iv breast cancer ajcc v8 clinical trial is actively enrolling qualified participants.

Is participation in this Scottsdale clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial in Scottsdale, AZ

Q: How do I join the anatomic stage iv breast cancer ajcc v8 clinical trial in Scottsdale?

To join this clinical trial in Scottsdale, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Anatomic Stage IV Breast Cancer AJCC v8 Study in Scottsdale

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.

Sponsor: Mayo Clinic

Who Can Participate

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)

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

Ability to undergo re-staging CT scans as required by the protocol

Willing to return to enrolling institution at the specified frequency for follow-up (during the active monitoring phase of the study)

Exclusion Criteria

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

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

History of severe hypersensitivity reactions to fluorouracil or capecitabine

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Scottsdale?

Yes, this clinical trial (NCT06525766) has an active research site in Scottsdale, AZ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Anatomic Stage IV Breast Cancer AJCC v8 Treatment Options in Scottsdale, AZ

If you're searching for anatomic stage iv breast cancer ajcc v8 treatment options in Scottsdale, AZ, this clinical trial (NCT06525766) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Scottsdale research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced anatomic stage iv breast cancer ajcc v8 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all anatomic stage iv breast cancer ajcc v8 clinical trials near you to find additional studies recruiting in your area.

Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial in Scottsdale, AZ

Expert Care in Scottsdale

IRB Approved

No-Cost Care

Apply for This Scottsdale Location

Why Participate?

Simple Process