---
title: Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
nct_id: NCT00634634
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Rutgers, The State University of New Jersey
study_type: INTERVENTIONAL
primary_condition: Metastatic Breast Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00634634.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00634634"
ct_last_update_post_date: 2023-11-09
last_seen_at: "2026-05-12T06:35:38.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer

**Official Title:** Phase I/II Trial of Letrozole (Femara) and Sorafenib (Nexavar) in Postmenopausal Women With Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer

**NCT ID:** [NCT00634634](https://clinicaltrials.gov/study/NCT00634634)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 52
- **Lead Sponsor:** Rutgers, The State University of New Jersey
- **Collaborators:** Rutgers Cancer Institute of New Jersey, National Cancer Institute (NCI), Bayer, Novartis Pharmaceuticals
- **Conditions:** Metastatic Breast Cancer
- **Start Date:** 2008-08-11
- **Completion Date:** 2023-04-28
- **CT.gov Last Update:** 2023-11-09

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Sorafenib and Letrozole** (EXPERIMENTAL)

## Interventions

- **Sorafenib** (DRUG) — sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
- **Letrozole** (DRUG) — Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28

## Primary Outcomes

- **Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)** _(time frame: twenty eight days)_ — 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

- **Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib** _(time frame: 6 months)_
- **Median Progressive-Free Survival (PFS)** _(time frame: Approximately 4.6 years)_
- **Overall Survival (OS) Assessed as Mean Months** _(time frame: Approximately 4.6 years)_

## Locations (4)

- Georgetown University Hospital, Washington D.C., District of Columbia, United States
- Emory University, Atlanta, Georgia, United States
- Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
- Cooper Hospital/University Medical Center, Voorhees Township, New Jersey, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.georgetown university hospital|washington d.c.|district of columbia|united states` — added _(2026-05-12)_
- `locations.emory university|atlanta|georgia|united states` — added _(2026-05-12)_
- `locations.rutgers cancer institute of new jersey|new brunswick|new jersey|united states` — added _(2026-05-12)_
- `locations.cooper hospital/university medical center|voorhees township|new jersey|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00634634.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00634634*  
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