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New treatment option for Metastatic Triple-Negative Breast Carcinoma
Official title Neratinib in Combination With Ruxolitinib in Patients With mTNBC
ClinicalTrials.gov ID: NCT06008275
What this study is testing
What is Neratinib Oral Tablet?
Neratinib Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic triple-negative breast carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- A patient will be considered for enrollment in this study if all the following criteria are met:
- Female patients ≥18 years of age
- Have a diagnosis of metastatic TNBC previously treated with standard anthracycline, cyclophosphamide, and taxane chemotherapy, unless there was a...
- Have not received more than 4 prior chemotherapy regimens for metastatic disease. Prior platinum and/or taxane therapy in the adjuvant or metastatic...
- Have locoregional (e.g., breast, chest wall, regional lymphatic) or pulmonary or hepatic metastatic disease that is amenable to core needle biopsy...
You likely can't join if
- A patient will be ineligible for inclusion in this study any of the following criteria are met:
- Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study treatment. Administration of killed vaccines is...
- Has peripheral neuropathy ≥grade 2
- Has completed previous radiotherapy for metastatic disease \<2 weeks prior to study treatment initiation
- Has an active infection requiring systemic therapy
- Has significant cardiovascular disease, such as:
See the full eligibility criteria
- A patient will be considered for enrollment in this study if all the following criteria are met:
- Female patients ≥18 years of age
- 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...
- 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...
- 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...
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Have adequate hematologic function, defined by:
- Absolute neutrophil count (ANC) \>1500/µL
- Platelet count ≥100,000/ µL
- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
- Have adequate liver function, defined by:
- AST and ALT ≤2.5 x the upper limit of normal (ULN) or ≤5 x ULN in presence of liver metastases
- Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels \>1.5 × ULN
- Have adequate renal function, defined by: a. Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥30 mL/min
- Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met:
- Brain metastases which have been treated
- Off-treatment with steroids before administration of the first dose of treatment
- No ongoing requirement for dexamethasone or anti-epileptic drugs
- No clinical or radiological evidence of progression of brain metastases
- Patients must be accessible for treatment and follow-up.
- All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.
- A patient will be ineligible for inclusion in this study any of the following criteria are met:
- 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.
- Has peripheral neuropathy ≥grade 2
- Has completed previous radiotherapy for metastatic disease \<2 weeks prior to study treatment initiation
- Has an active infection requiring systemic therapy
- Has significant cardiovascular disease, such as:
- History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the last 6 months
- Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV, or history of CHF NYHA class III or IV.
- Has a known history of active tuberculosis
- 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.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
- 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
- liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
- 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...
- Has received prior systemic anti-cancer therapy within 2 weeks prior to study treatment.
- Has received investigational agents within 4 weeks prior to study treatment. Monoclonal antibody agents should have a 4-week (28 day) washout period.
- Any other investigational or anti-cancer treatments while participating in this study
- Any other active malignancy
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.