Functional Precision Oncology for HER2 Negative or Non-amplified Metastatic or Recurrent, Unresectable Breast Cancer, FORESEE study

Inclusion Criteria

• STEP 1 REGISTRATION CRITERIA:
• PATIENTS: Male or female subject aged >= 18 years
• PATIENTS: Her2 negative on immunohistochemistry or nonamplified breast cancer
• PATIENTS: Metastatic or recurrent unresectable breast cancer: * Patients with triple-negative breast cancer without prior treatment in the metastatic setting OR * Patients with hormone receptor-positive breast cancer that: ** Has exhausted or refused all endocrine monotherapy or endocrine therapeutic combinatorial options; AND ** Has not yet been treated with chemotherapy in the metastatic settings, but or for whom chemotherapy is indicated
• PATIENTS: Willing and capable (per treating investigator’s assessment) to undergo a baseline tumor collection. Tumor collection may include a solid tumor tissue sample or a fluid sample containing tumor cells
• PATIENTS: Patient can safely undergo tumor collection: * The tumor is reasonably accessible to tumor collection * The tumor is amenable to tumor collection, e.g. does not abut neurovascular structures * If the patient receives anticoagulation, anticoagulation can be safely withheld to accommodate for tissue acquisition * The patient does not have a medical condition that would render a tumor acquisition a high-risk procedure (e.g. tumor material acquisition from lung metastases in a patient with emphysema)
• PATIENTS: Life expectancy of >= 6 months as assessed by the treating investigator
• PATIENTS: Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• PATIENTS: Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: * Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have estradiol and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy) * Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
• PATIENTS: Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
• PATIENTS: At least one lesion (measurable or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), plain X-ray, or physical examination
• PHYSICIANS: Physician is the treating medical oncologist for a patient who meets all of the inclusion criteria and none of the exclusion criteria
• PHYSICIANS: Willing and able to answer the physician questionnaires at the protocol required time points
• PHYSICIANS: Willing and able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
• STEP 2 REGISTRATION CRITERIA
• PATIENTS: Patient continues to meet step 1 registration criteria
• PATIENTS: Successful acquisition of a solid tumor biopsy sample containing >= 20% tumor content, or malignant fluid sample (e.g. pleural or pericardial effusion or ascites) confirmed to contain malignant cells
• PATIENTS: Sufficient material for Tempus commercial genomics testing and Welm lab genomics from the tumor collection; or sufficient archival tissue for Tempus and Welm lab genomics; or blood sample as allowed for liquid biopsy commercial assay
• PATIENTS: Sample from tumor collection is the type of sample that is feasible for organoid development as determined by the investigator

Exclusion Criteria

• PATIENTS: Diagnosis of any other malignancy with a life expectancy of < 5 years
• PATIENTS: The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: * Myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (> New York Heart Association classification class IIB) or a serious cardiac arrhythmia requiring medication * Renal or liver disease that prohibits the patient from receiving at least single-agent full recommended dose chemotherapy
• PATIENTS: The patient cannot safely undergo tumor collection for reasons including but not limited to: * Tumor is inaccessible * The patient requires anticoagulation which cannot be withheld * The patient has bleeding diathesis * Any other reason that would render acquisition a high-risk procedure
• PATIENTS: Patient cannot or is unwilling to receive chemotherapy
• PATIENTS: Known brain metastases or cranial epidural disease * Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before step 1 registration for study will be allowed on trial. Subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the step 1 registration for study
• PATIENTS: Patient’s only site amenable to tumor collection to generate organoids is hepatic metastases