Clinical trial NCT00542191: Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer
Official title: Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Triple negative (ER/PR negative; HER2 negative)
Lead sponsor: Leo W. Jenkins Cancer Center
Sponsor class: OTHER
First posted: 2007-10-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Women with a diagnosed "triple-negative" proxy of basal-like breast cancer confirmed on a core biopsy and larger than 2 cm will be treated neoadjuvantly with the Livingston metronomic regimen of 12 weeks of weekly doxorubicin 24 mg/m2 and daily oral cyclophosphamide 60 mg/m2 followed by 12 successive weeks of taxol 80 mg/m2 and carboplatin AUC 2. Although clinical response will be evaluated prior to surgery, the primary end-point is the pathologic response. Secondary end-points will be DFS and OS based upon standard of care surveillance. A pathologic complete response (pCR) will require no histologic evidence of residual malignant cells seen in the primary tumor area specimen or the lymph nodes. Standard of care surgery and radiation therapy will be undertaken.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 1) Pathologic Response
timeFrame: Upon completion therapy after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Brody School of Medicine at East Carolina University
state: North Carolina
Study officials:
affiliation: Brody School of Medicine at East Carolina University
name: Paul Walker, MD
role: PRINCIPAL_INVESTIGATOR
References:
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