Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials.

Key facts

Study ID

NCT00542191

Run by

Leo W. Jenkins Cancer Center

People needed

30

Starts

2007-07-01

Expected to finish

2016-08-02

Last updated by the study team

2021-05-26

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with Estrogen Receptor (ER), Progesterone Receptor (PR),and HER2 negative invasive breast cancer confirmed on core biopsy.(Note: HER2 negative by FISH preferred; HER2 0 or 1+ by IHC acceptable)
• Primary tumor size 2cm or greater by physical exam or radiographic measurements.(Note: Locally advanced T4 or inflammatory breast cancer is eligible.)
• Assessment of pre-treatment axillary lymph nodal status (Note: FNA biopsy if palpable or sentinel lymph node biopsy (SLNB) if not palpable preferred; clinical exam acceptable.)
• Absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3
• Normal myocardial left ventricular function
• Serum creatinine < 2.0 mg/dl
• Total bilirubin and AST < 3X upper limits normal

You may not qualify if…

• Recurrent or metastatic breast cancer findings (Note: If oncologically felt to be a second breast primary, patient eligible for this protocol)
• Another active cancer present
• Medical contraindications to chemotherapy or surgery
• First trimester pregnancy
• Breast feeding

Where it is running

• Brody School of Medicine at East Carolina University — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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