BridgeMD
New treatment option for HER2-negative Breast Cancer
Official title Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)
ClinicalTrials.gov ID: NCT05660083
What this study is testing
What is L-NMMA?
L-NMMA is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for her2-negative breast cancer.
Also referred to as iNOS inhibitor.
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
- This is a research study to test the safety and effectiveness of using the drug alpelisib together with chemotherapy (nab-paclitaxel) and a drug called L-NMMA in patients with HER2 negative metastatic or locally advanced metaplastic breast cancer, who have not responded to previous treatments. Participants in this study in addition to the standard care chemotherapy will also receive the drug alpelisib and L-NMMA.
- Phase 2: a mid-size study of how well it works
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
You may be able to join if
- The patient (or legally acceptable representative if applicable) provides written informed consent for the study.
- At least 18 years of age on the day of informed consent signing.
- Histologically confirmed HER2 negative MpBC and/or Triple Negative Breast Cancer (TNBC) with squamous and/or sarcomatoid elements, including osseous...
- HER2 negative status as defined by the current American Society of Clinical Oncology and College of American Pathologists guidelines at time of study...
- Locally advanced inoperable or metastatic MpBC with measurable disease by RECIST 1.1 Both first- and second-line patients will be eligible for this...
You likely can't join if
- Concomitant use of strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4. The patient must have discontinued strong CYP3A4 inhibitors or...
- Currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis, or otherwise. Therapy with DOACs, heparin, low...
- Concurrent use of medications that interact with nitrate/nitrite levels (Examples included in Appendix 3).
- Received previous treatment with nab-paclitaxel, Pl3K inhibitor, AKT inhibitor, or mTOR inhibitor.
- Known history of Steven Johnson's syndrome or toxic epidermal necrolysis.
- Since HAART agents are metabolized by CYP3A4, HIV positive patients will be excluded from this trial.
See the full eligibility criteria
Who can join
- The patient (or legally acceptable representative if applicable) provides written informed consent for the study.
- At least 18 years of age on the day of informed consent signing.
- Histologically confirmed HER2 negative MpBC and/or Triple Negative Breast Cancer (TNBC) with squamous and/or sarcomatoid elements, including osseous, chondroid, and spindle morphology.
- HER2 negative status as defined by the current American Society of Clinical Oncology and College of American Pathologists guidelines at time of study entry.
- Locally advanced inoperable or metastatic MpBC with measurable disease by RECIST 1.1 Both first- and second-line patients will be eligible for this trial. Patients may have received prior immunotherapy, per standard of...
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ and marrow function as defined below:
- Hemoglobin ≥9.0 g/dl (without blood transfusion within 2 weeks of laboratory test used to determine eligibility)
- Absolute neutrophil count ≥1000/μL (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
- Platelet count ≥100,000/μL (without transfusion within 2 weeks of laboratory test used to determine eligibility)
- Serum total bilirubin (TB) ≤1.5 x institutional upper limit of normal (ULN; In the case of known Gilbert's syndrome, a higher serum TB [\>1.5 x ULN] is allowed),
- Aspartate transaminase/alanine transaminase ≤5 x institutional ULN
- Creatinine ≤1.5X the ULN or measured creatinine clearance ≥ 60 mL/min/1.
- Fasting blood glucose of ≤140 mg/dl and HgbA1c ≤7.0.
- Ability to swallow oral medication.
- Ability to take aspirin.
- Women of childbearing potential must agree to use contraception for the duration of the study through 90 days after the last dose of study treatment. A condom is required for all sexually active male participants to...
- If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting the study treatment.
- Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
What rules you out
- Concomitant use of strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4. The patient must have discontinued strong CYP3A4 inhibitors or strong CYP3A4 inducers for at least 1 week prior to study treatment...
- Currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis, or otherwise. Therapy with DOACs, heparin, low molecular weight heparin, direct oral anticoagulants or fondaparinux is...
- Concurrent use of medications that interact with nitrate/nitrite levels (Examples included in Appendix 3).
- Received previous treatment with nab-paclitaxel, Pl3K inhibitor, AKT inhibitor, or mTOR inhibitor.
- Known history of Steven Johnson's syndrome or toxic epidermal necrolysis.
- Since HAART agents are metabolized by CYP3A4, HIV positive patients will be excluded from this trial.
- Poorly controlled hypertension at baseline (defined as systolic blood pressure \>150 mm Hg). Isolated, unconfirmed systolic BP elevations will NOT exclude participation. Patients with medication-controlled hypertension...
- Has any of the following cardiac abnormalities:
- Symptomatic congestive heart failure
- History of documented congestive heart failure (New York Heart Association functional classification III-IV)
- Documented cardiomyopathy
- Left ventricular ejection fraction \<50% as determined by multigated acquisition scan or echocardiogram
- Myocardial infarction \~6 months prior to enrollment
- Unstable angina pectoris
- Serious uncontrolled cardiac arrhythmia
- Symptomatic pericarditis
- History of congenital QT prolongation
- Absolute corrected QT interval of \>480 msec in the presence of potassium \>4.0 mEq/L and magnesium \>1.8 mg/dl.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks prior to study treatment administration. NOTE: Patients who have entered the...
- Known or suspected hypersensitivity to any component or excipient of the proposed regimen (nab-paclitaxel, alpelisib, iNOS inhibitor, aspirin).
- Known additional malignancy that requires active treatment.
- Pneumonitis/ interstitial lung disease on baseline CT scan of the chest or moderate to severe chronic lung disease
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal surgery disease, or an unknown reason.
- Symptomatic/untreated metastatic central nervous system disease.
- Type I diabetes mellitus irrespective of Hgb A1c OR uncontrolled type II diabetes mellitus defined as hemoglobin A1c \>7%.
- Uncontrolled gastric ulcer
- ≥ Grade 2 sensory neuropathy
- Osteonecrosis of jaw
- Pancreatitis
- Pregnant, breastfeeding or expecting to conceive children within the projected duration of the study, starting with the prescreening or screening visit through 30 days after the last dose of study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
- Houston, 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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States; Houston, 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.