Clinical trial · Interventional
Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
Phase I/II Trial of Letrozole (Femara) and Sorafenib (Nexavar) in Postmenopausal Women With Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer
- 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)
Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib and Letrozole
- interventionNames
- Drug: Sorafenib
- Drug: Letrozole
Primary outcomes (1)
- measure
- Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)
- timeFrame
- twenty eight days
- description
- The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.
Secondary outcomes (3)
- measure
- Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed invasive breast cancer 2. Stage IIIB, IIIC with T4 lesion or Stage IV disease 3. Breast cancer must be ER-positive and/or PR-positive 4. Age ³ 18 years of age 5. ECOG performance status 0, 1 or 2 6. Able to swallow and oral medication 7. Adequate end organ function 8. Written informed consent Exclusion Criteria: 1. Prior hormonal therapy for metastatic disease 2. Prior chemotherapy for metastatic disease 3. Prior treatment with sorafenib 4. Brain metastases or leptomeningeal disease 5. Evidence or history of bleeding 6. Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
References
Publications (0)
Data not yet available