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New treatment option for Triple Negative Breast Cancer
Official title Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)
ClinicalTrials.gov ID: NCT04427293
What this study is testing
What is Lenvatinib?
Lenvatinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for triple negative breast cancer.
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 single arm study of a window of opportunity in which participants with previously untreated triple negative breast cancers (TNBC) who are candidates for potentially curative surgery will receive lenvatinib 12 mg daily for 7 and pembrolizumab 200 mg IV on day 1 prior to surgery
- 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
- Age ≥ 18 years of age at time of consent
- Histologically confirmed invasive breast carcinoma documented by core needle biopsy or incisional biopsy (excisional biopsy is not allowed). AJCC 8th...
- Must be candidates for curative surgical resection
- Have an FFPE diagnostic core biopsy specimen available that is determined by the study pathologist to be adequate for planned analyses
- Definitive surgical excision of the primary breast tumor (either partial mastectomy or total mastectomy) and ipsilateral axillary lymph node sampling...
You likely can't join if
- Active infection requiring systemic therapy
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)
- Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor...
- Previous treatment with lenvatinib or any immune checkpoint inhibitor within the past 2 years
- Treatment with any investigational drug within 14 days prior to registration or within 5 half-lives of the investigational product, whichever is...
- Major surgery within 14 days prior to registration or has not recovered from major side effects of a major surgery (tumor biopsy and placement of an...
See the full eligibility criteria
Who can join
- Age ≥ 18 years of age at time of consent
- Histologically confirmed invasive breast carcinoma documented by core needle biopsy or incisional biopsy (excisional biopsy is not allowed). AJCC 8th edition clinical stage T1b-T3/N0-N3/M0 by physical exam or radiologic...
- Must be candidates for curative surgical resection
- Have an FFPE diagnostic core biopsy specimen available that is determined by the study pathologist to be adequate for planned analyses
- Definitive surgical excision of the primary breast tumor (either partial mastectomy or total mastectomy) and ipsilateral axillary lymph node sampling (sentinel lymph node biopsy or axillary dissection) is planned...
- Estrogen Receptor (ER)- and Progesterone Receptor (PR)-negative as determined by immunohistochemistry (IHC), and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast...
- Less than or equal to 10% of tumor cells staining for ER and for PR by immunohistochemistry (IHC)
- HER2-negative, as defined by ASCO/CAP guidelines55
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 30 days prior to study registration
- Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 30 days prior to registration Hematological Leukocytes ≥2,500/mm3 Platelet count ≥ 100,000/mm3 Absolute...
- No evidence of distant metastases (M0 as per AJCC staging guidelines)
- Provided written informed consent and HIPAA authorization for release of personal health information, approved by an Institutional Review Board (IRB)
- NOTE: HIPAA authorization may be included in the informed consent or obtained separately
- Women of childbearing potential (WOCP) must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required within 14 days of study registration. If the urine test cannot be confirmed as...
- Women of childbearing potential (WOCP) must be willing to use two effective methods of birth control such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), use of...
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
What rules you out
- Active infection requiring systemic therapy
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)
- Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with...
- Previous treatment with lenvatinib or any immune checkpoint inhibitor within the past 2 years
- Treatment with any investigational drug within 14 days prior to registration or within 5 half-lives of the investigational product, whichever is longer
- Major surgery within 14 days prior to registration or has not recovered from major side effects of a major surgery (tumor biopsy and placement of an indwelling venous access device are not considered major surgery)
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of this investigational regimen, as determined by the treating Medical...
- Known history of AIDS (HIV testing is not mandatory). HIV-positive individuals on active HARRT therapy with virologic suppression (defined as an HIV-1 RNA level below the lower limit of detection of the assay used)...
- . people with any of the following conditions:
- History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 28 days prior to registration
- History of cerebrovascular accident (CVA) or transient ischemic attack within 6 months prior to registration
- History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to registration
- Symptomatic congestive heart failure (New York Heart Association III-IV) or documented current left ventricular (LV) systolic dysfunction with left ventricular ejection fraction (LVEF) \<50% on most recent assessment of...
- Clinically significant cardiac ventricular arrhythmias (e.g. sustained ventricular tachycardia/ventricular fibrillation) or high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block) unless...
- Any concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate subject participation in the clinical study or compromise...
- Any condition that, in the opinion of the investigator, might jeopardize the safety of the patient or interfere with protocol compliance
- Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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 Chicago, Illinois, 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.