Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT04123704
Eligibility Criteria:
Inclusion Criteria:
* Women or men age 18 and older
* Metastatic or locally advanced inoperable breast cancer (beyond curative management) that is measurable according to RECIST 1.1 criteria. Note: Patients with bone-only disease are eligible if there is at least 1 lytic lesion that can be followed for response.
* Tumor is estrogen receptor (ER) negative and progesterone receptor (PR) negative per the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) Guidelines of 2010.
* Tumor is HER2neu negative per ASCO/CAP Guidelines of 2018
* Patient has archival tissue from metastatic or locally advanced breast cancer for the analysis of PTPN12 status
* At least one prior line of chemotherapy with or without a PD-L1 or PD-1 antibody in the metastatic setting
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
* Normal organ and marrow function as defined below:
* Absolute neutrophil count \> 1000/mcL
* Hemoglobin \> 11 g/dL
* Platelets \> 100,000/mcL
* Total bilirubin \< 1.5 X normal institutional limits
* Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \< 2.5 X institutional ULN or ≤ 5.0 × ULN for patients with documented liver metastases.
* Creatinine within normal institutional limits
* Creatinine clearance ≥ 30 mL/min
* Normal left ventricular ejection (LVEF) function defined as normal left ventricular wall motion and ejection fraction of ≥ 50%.
* If patient has brain metastasis, documented treatment and stability for at least 30 days by scans and off steroids at the time of enrollment
* Women of child bearing age and actively menstruating must have a negative pregnancy test prior to starting study treatment.
* If sexually active in a way that could lead to pregnancy, participant must agree to use a highly effective method of birth control starting at the time of informed consent and continuing throughout the study and for at least 3 months after the final dose of sitravatinib.
* Ability to understand and the willingness to give informed consent
Exclusion Criteria:
* Uncontrolled hypertension defined as systolic blood pressure \> 150 and/or diastolic blood pressure \> 100, on two or more occasions within 30 days prior to enrollment.
* Imaging suggestive of Lymphangitic carcinomatosis in the lung, or use of home oxygen
* Untreated brain metastases.
* Women who are pregnant or nursing
* Concurrent metastatic disease of another tumor type
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of sitravatinib
* History of stroke, pulmonary embolus (PE), or myocardial infarction (MI)
* Known proteinuria of ≥ 2 g urinary protein/24 h
* HIV-positive participants
* History of Hepatitis C or Hepatitis B infection
* History of congestive heart failure (CHF), and/or LVEF less than 50%
* Concurrent use of medications that prolong QTc (listed in Section 9, Table 11). These medications need to be discontinued at least 2 weeks prior to starting study treatment.
* Concurrent medical condition that, in the sole judgment of the principal investigator, would make the patient inappropriate for trial participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04123704
Study Brief:
Protocol Section:
NCT04123704