- Newly diagnosed clinical stage II or III breast cancer with complete surgical
excision of the breast cancer after neoadjuvant chemotherapy as the treatment goal.
- Patients with PR+ tumors are allowed.
- HER2 negative by FISH or IHC staining 0 or 1+.
- ER less than Allred score of 3 or less than 1% positive staining cells in the
invasive component of the tumor
- Tumor size at least 2cm in one dimension by clinical or radiographic exam (WHO
- At least 18 years of age.
- ECOG performance status 2
- Normal bone marrow and organ function as defined below:
- Leukocytes 3,000/mcL
- Absolute neutrophil count 1,500/mcl
- Platelets 100,000/mcl
- Serum bilirubin within (or under ) normal limits (OR total bilirubin 3.0 x
IULN with direct bilirubin within normal range in patients with well documented
- AST(SGOT)/ALT(SGPT) within (or under ) normal limits
- Creatinine within (or under) normal institutional limits OR creatinine clearance
60 mL/min/1.73 m2 for patients with creatinine levels above institutional
- Patients may be pre- or post-menopausal. Women of childbearing potential must agree
to use adequate contraception (hormonal or barrier method of birth control,
abstinence) prior to study entry and for the duration of study participation. Should
a woman become pregnant or suspect she is pregnant while participating in this study,
she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed
consent document (or that of legally authorized representative, if applicable).
- Prior systemic therapy for the indexed breast cancer.
- A history of other malignancy 5 years previous with the exception of basal cell or
squamous cell carcinoma of the skin which were treated with local resection only or
carcinoma in situ of the cervix.
- Patients with bilateral or inflammatory breast cancer.
- Currently receiving any other investigational agents.
- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to docetaxel or carboplatin.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
- Pregnant and/or breastfeeding. Patient must have a negative serum pregnancy test
within 7 days of study entry if premenopausal.
- Known HIV-positivity.
- Sentinel lymph node biopsy
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Female