Clinical trial · Interventional
Phase II Study of Single Agent Lenvatinib
A Phase II Window-of-opportunity Study of Single Agent Lenvatinib in Estrogen Receptor Positive Early Stage Breast Cancer
NCT03168074CI-TRIAL-00028143unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Investigators hypothesize that single agent lenvatinib has biological activity in estrogen receptor positive breast cancer, and that the effects are more pronounced in patients with positive RET expression in the tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenvatinib | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lenvatinib
- description
- Eligible patients will be treated with approximately 2 weeks of single agent lenvatinib (range 10-28 days, depending on the date of breast cancer surgery; last dose of lenvatinib to be administered no later than 48 hours before surgery in patients who are planned to receive ≤14 days lenvatinib, and no later than 120 hours before surgery in patients who are planned to receive 15-28 days lenvatinib).
- interventionNames
- Drug: lenvatinib
Primary outcomes (6)
- measure
- Biological effects of short-course single agent lenvatinib in estrogen receptor positive breast cancer using a window-of-opportunity design
- timeFrame
- after 10-28 days of single agent lenvatinib
- description
- To evaluate Ki67 changes. The Ki-67 protein is a cellular marker for proliferation. It is strictly associated with cell proliferation. Ki67 has been shown to be a surrogate marker of biological activity and treatment response in estrogen receptor positive breast cancer treated with endocrine therapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria:
Patients must fulfill ALL the following inclusion criteria
* Female ≥18 years
* Histological or cytological diagnosis of breast carcinoma
* No prior treatment for current breast carcinoma
* Scheduled for upfront definitive breast cancer surgery (breast conserving surgery or mastectomy with or without sentinel lymph node biopsy or axillary lymph node clearance)
* Estrogen receptor positive (\>1%)
* Adequate bone marrow, renal and liver function
* Adequate organ function including the following:
* Bone marrow:
* Absolute neutrophil (segmented and bands) count (ANC) \>= 1.5 x 109/L
* Platelets \>= 100 x 109/L
* Hepatic:
* Bilirubin \< = 1.5 x upper limit of normal (ULN),
* ALT or AST \< = 2.5x ULN, (or \< = 5 X with liver metastases)
* Renal:
* Creatinine \< = 1.5x ULN
* Normal thyroid function
* Able to swallow pills
* Able to sign informed consent
* Able to comply with study-related procedures
Exclusion Criteria:
Patients will be excluded from the study for any of the following reasons:
* Scheduled for neoadjuvant systemic therapy
* Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
* Treatment within the last 28 days with any investigational drug.
* Major surgery within 28 days of study drug administration.
* Pregnancy.
* Breast feeding.
* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
* Poorly controlled diabetes mellitus.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
* Symptomatic brain metastasis.
* History of significant neurological or mental disorder, including seizures or dementia.References
Publications (3)
- BACKGROUNDBoulay A, Breuleux M, Stephan C, Fux C, Brisken C, Fiche M, Wartmann M, Stumm M, Lane HA, Hynes NE. The Ret receptor tyrosine kinase pathway functionally interacts with the ERalpha pathway in breast cancer. Cancer Res. 2008 May 15;68(10):3743-51. doi: 10.1158/0008-5472.CAN-07-5100. PMID 18483257
- BACKGROUNDPlaza-Menacho I, Morandi A, Robertson D, Pancholi S, Drury S, Dowsett M, Martin LA, Isacke CM. Targeting the receptor tyrosine kinase RET sensitizes breast cancer cells to tamoxifen treatment and reveals a role for RET in endocrine resistance. Oncogene. 2010 Aug 19;29(33):4648-57. doi: 10.1038/onc.2010.209. Epub 2010 Jun 7. PMID 20531297
- BACKGROUNDMorandi A, Martin LA, Gao Q, Pancholi S, Mackay A, Robertson D, Zvelebil M, Dowsett M, Plaza-Menacho I, Isacke CM. GDNF-RET signaling in ER-positive breast cancers is a key determinant of response and resistance to aromatase inhibitors. Cancer Res. 2013 Jun 15;73(12):3783-95. doi: 10.1158/0008-5472.CAN-12-4265. Epub 2013 May 6. PMID 23650283