Neratinib in Combination With Ruxolitinib in Patients With mTNBC
Pilot Clinical Trial Examining the Safety and Efficacy of Neratinib in Combination With Ruxolitinib in Patients With Chemotherapy-pretreated Metastatic Triple Negative Breast Cancer With Chest Wall Recurrence
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
- Female only
- 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
Not stated in the study description — ask the study team about visits and procedures.
- 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 how safe and effective neratinib and ruxolitinib are when taken together. It is for women with triple-negative breast cancer that has spread and has already been treated with chemotherapy.
The goal of this clinical trial is to assess the safety and efficacy of combined ruxolitinib and neratinib in patients with chemotherapy-pretreated metastatic triple negative breast cancer. This trial will evaluate one dosing schedule of neratinib in ruxolitinib in patients with metTNBC with locoregional recurrence.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 18 or older with triple-negative breast cancer that has spread. Some tumors with low estrogen receptor levels also qualify.
- Prior treatment with anthracycline, cyclophosphamide, and taxane chemotherapy. Prior doxorubicin is not required if it was unsafe for you.
- Usually no more than 4 past chemotherapy treatments for cancer that has spread. The study doctor may allow more.
- Cancer in the breast, chest wall, nearby lymph nodes, lungs, or liver that can be sampled with a needle. A skin sample or a doctor's exception may be allowed if sampling is unsafe.
- Able to do daily activities with little or no limits, with blood counts, liver tests, and kidney tests that meet study requirements.
- If cancer has spread to the brain, it must be treated and not getting worse. You must be off steroids before treatment and not need dexamethasone or seizure medicines.
- Able to attend treatment and follow-up visits, understand the study, and sign a consent form.
- If you can become pregnant, agree to use effective birth control during the study and for at least 3 months after the last dose.
Who can't join
- Pregnant or breastfeeding, or having another active cancer.
- A live or weakened-live vaccine within 30 days before study treatment. Killed vaccines are allowed.
- Moderate or worse nerve damage outside the brain and spinal cord, which may cause numbness, tingling, or pain.
- An active infection needing medicine that treats the whole body, or a known history of active tuberculosis.
- Serious heart disease, including certain levels of heart failure, or a heart attack, serious heart blood-flow problem, or heart artery procedure within 6 months.
- Severe or uncontrolled illness, including serious lung or liver disease, or another condition that the doctor believes makes participation unsafe or affects the study.
- Radiation for cancer that has spread or whole-body cancer treatment within 2 weeks before study treatment; an experimental drug or monoclonal antibody treatment within 4 weeks.
- Other experimental treatments or cancer treatments during the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * A patient will be considered for enrollment in this study if all the following criteria are met: 1. Female patients ≥18 years of age 2. Have a diagnosis of metastatic TNBC previously treated with standard anthracycline, cyclophosphamide, and taxane chemotherapy, unless there was a contraindication to doxorubicin, in which case prior treatment with this agent is not required. Note. TNBC defined as ER-negative tumors with ≤10% tumor nuclei immunoreactivity, or "ER Low Positive" as defined by the updated ASCO/CAP guidelines 2020. 3. Have not received more than 4 prior chemotherapy regimens for metastatic disease. Prior platinum and/or taxane therapy in the adjuvant or metastatic setting is permitted. Patients with more than 4 prior regimens may be allowed on study per physician discretion, if ECOG PS is 0-1. 4. Have locoregional (e.g., breast, chest wall, regional lymphatic) or pulmonary or hepatic metastatic disease that is amenable to core needle biopsy. If a research biopsy from a patient's metastatic disease cannot be safely obtained, a skin biopsy is permitted. If a skin biopsy cannot be safely obtained, patients may still be eligible, per physician discretion. 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Have adequate hematologic function, defined by: 1. Absolute neutrophil count (ANC) \>1500/µL 2. Platelet count ≥100,000/ µL 3. Hemoglobin ≥9 g/dL or ≥5.6 mmol/L 7. Have adequate liver function, defined by: 1. AST and ALT ≤2.5 x the upper limit of normal (ULN) or ≤5 x ULN in presence of liver metastases 2. Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels \>1.5 × ULN 8. Have adequate renal function, defined by: a. Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥30 mL/min 9. Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met: 10. Brain metastases which have been treated 11. Off-treatment with steroids before administration of the first dose of treatment 12. No ongoing requirement for dexamethasone or anti-epileptic drugs 13. No clinical or radiological evidence of progression of brain metastases 14. Patients must be accessible for treatment and follow-up. 15. All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry. Exclusion Criteria: * A patient will be ineligible for inclusion in this study any of the following criteria are met: 1. Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study treatment. Administration of killed vaccines is allowed. 2. Has peripheral neuropathy ≥grade 2 3. Has completed previous radiotherapy for metastatic disease \<2 weeks prior to study treatment initiation 4. Has an active infection requiring systemic therapy 5. Has significant cardiovascular disease, such as: 1. History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the last 6 months 2. Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV, or history of CHF NYHA class III or IV. 6. Has a known history of active tuberculosis 7. Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug. 8. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as: 1. severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air 2. liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C). 9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's full participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Treating Physician. 10. Has received prior systemic anti-cancer therapy within 2 weeks prior to study treatment. 11. Has received investigational agents within 4 weeks prior to study treatment. Monoclonal antibody agents should have a 4-week (28 day) washout period. 12. Any other investigational or anti-cancer treatments while participating in this study 13. Any other active malignancy
Study sites (1)
TX
- Baylor University Medical Center, Baylor Charles A Sammons Cancer Center · Dallas, TX 75246Page E Blas, MA · Study contact · 214-820-5424 · page.blas@bswhealth.orgJoyce A O'Shaughnessy, MD · Principal investigatorMore trials in Dallas