Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer
18 Years
75 Years
Female
Breast Cancer
Trial Information
Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
1) Pathologic response
Outcome Time Frame:
within 3 weeks of completing neoadjuvant chemotherapy
Safety Issue:
No
Principal Investigator
Paul Walker, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Brody School of Medicine at East Carolina University
Authority:
United States: Institutional Review Board
Study ID:
LJCC 07-03
NCT ID:
NCT00542191
Start Date:
July 2007
Completion Date:
June 2018
Related Keywords:
- Breast Cancer
- Triple negative (ER/PR negative; HER2 negative)
- Breast Neoplasms
Name | Location |
|---|---|
| Brody School of Medicine at East Carolina University | Greenville, North Carolina 27858 |
