Clinical trial · Interventional
Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
A Phase II Study of Adding the Multikinase Inhibitor Sorafenib (Nexavar) to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
NCT00525161CI-TRIAL-00016699terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual and loss of funding
Summary
Brief summary (as posted)
The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib & Endocrine Therapy
- description
- Sorafenib \& Endocrine Therapy
- interventionNames
- Drug: sorafenib
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 12 weeks after treatment & 8 weeks after initial documentation of response
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients were followed monthly for clinical and toxicity evaluation. Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All subjects must be female. * Age ≥ 18 years old. * Histologically proven carcinoma of the breast. * Estrogen receptor and/or Progesterone positive disease. * Metastatic or locally advanced disease. * Patients on a preexisting endocrine agent for at least 3 months before enrollment. * Have residual measurable disease after 1. maximal response to endocrine therapy or 2. no response to endocrine therapy or 3. progressive non-visceral disease on endocrine therapy. * Must be able to provide a tumor block from either the primary or metastatic site, if available. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. * Adequate organ function. Exclusion Criteria: * Patients with rapidly progressive disease on endocrine therapy who would otherwise be candidates for chemotherapy. * Other coexisting malignancies, with the exception of basal cell carcinoma or cervical carcinoma in situ. * Prior use of anti-angiogenic agents. * As judged by the investigator, uncontrolled intercurrent illness. * Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis. * Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment. * Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort. * Known or suspected allergy to sorafenib or any agent given in the course of this trial. * A serious non-healing wound or ulcer. * Evidence or history of bleeding diathesis or coagulopathy. * Major surgery, open biopsy or significant traumatic injury within the 4 weeks prior to the first dose of the study drug. * Pulmonary hemorrhage/bleeding event ≥ Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 within the 4 weeks prior to the first dose of study drug. * Pregnancy * Any condition that impairs patient's ability to swallow whole pills. * Documented malabsorption problem.
References
Publications (1)
- RESULTMassarweh S, Moss J, Wang C, Romond E, Slone S, Weiss H, Karabakhtsian RG, Napier D, Black EP. Impact of adding the multikinase inhibitor sorafenib to endocrine therapy in metastatic estrogen receptor-positive breast cancer. Future Oncol. 2014 Dec;10(15):2435-48. doi: 10.2217/fon.14.99. PMID 24826798