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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

find phase II dose of study drugs in pts w/hormone receptor-positive locally advanced or metastatic breast ca. find clinical benefit rate (pts who achieve a CR, PR, or SD in the first-line trt of postmenopausal pts.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Antoinette Tan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMDNJ/CINJ

Authority:

United States: Institutional Review Board

Study ID:

040706

NCT ID:

NCT00634634

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • breast cancer
  • Postmenopausal Women with Hormone Receptor-Positive Locally Advanced Breast Cancer
  • Breast Neoplasms

Name

Location

Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Emory UniversityAtlanta, Georgia  30322
Georgetown University HospitalWashington, District of Columbia  20007