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Completed

NCT Number: NCT00634634

Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Georgetown University Hospital, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed invasive breast cancer
  • Stage IIIB, IIIC with T4 lesion or Stage IV disease
  • Breast cancer must be ER-positive and/or PR-positive
  • Age ³ 18 years of age
  • ECOG performance status 0, 1 or 2
  • Able to swallow and oral medication
  • Adequate end organ function
  • Written informed consent

Exclusion criteria

  • Prior hormonal therapy for metastatic disease
  • Prior chemotherapy for metastatic disease
  • Prior treatment with sorafenib
  • Brain metastases or leptomeningeal disease
  • Evidence or history of bleeding
  • Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months

Treatment and study plan

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.

Other names: Nexavar

letrozole

Drug

Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28

Other names: Femara

Primary outcomes

  1. 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

  1. Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib

    Time frame: 6 months

    Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the malignant lymph nodes are used for tumor measurements. Included will be: complete response, partial response or stable disease of letrozole and sorafenib in the treatment of postmenopausal participants with hormone receptor- positive locally advanced or metastatic breast cancer.

    Clinical Benefit Rate (CBR) = Progressive Free (PF) + Stable Disease (SD)

  2. Median Progressive-Free Survival (PFS)

    Time frame: Approximately 4.6 years

    PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1,0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0f or target lesions, PD is at least a 20% increase in sum LD of target lesions, taken as reference the smallest sum LD recorded at treatment started. Based on the time between the first day of treatment and and the date of disease progression.

  3. Overall Survival (OS) Assessed as Mean Months

    Time frame: Approximately 4.6 years

    From the start of treatment to the end of the study (three years) that participants are still alive. Measured by the mean number.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Bayer
  • National Cancer Institute (NCI)
  • Novartis Pharmaceuticals
  • Rutgers Cancer Institute of New Jersey

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2019
Study completion
2023
First posted
Mar 13, 2008
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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