Laboratory-Treated T Cells After Second-Line Chemotherapy in Treating Patients With HER2/Neu-Negative Metastatic Breast Cancer

Inclusion:

* Metastatic Breast Cancer. Histologically confirmed breast cancer with evidence of metastatic disease (need not be biopsy proven) or locally, advanced unresectable disease.
* Patients with 0-2+ HER2 expression as determined by immunohistochemistry staining and/or FISH ratio \<2.0, with the above pathologic criteria will be eligible.
* Hormone Therapy. Patients on prior hormonal therapy are eligible. Hormonal therapy will be stopped 2 weeks prior to leukopheresis. Hormone therapy may be restarted after leukopheresis
* Patients may have received any number of prior lines of chemotherapy providing Leukopheresis is done when the lymphocyte count has recovered to ≥500 cells/mm3 and there are no residual chemotoxicities that would prevent leukopheresis.
* Patients who have received Radiotherapy are eligible providing Leukopheresis is done at least 4 weeks after radiation to the axial skeleton.
* Patients who have received prior biological agents are eligible.
* Patients with measurable and non-measurable disease are eligible.
* Age \> or = to 18 years
* ECOG 0-1 or Karnofsky \> or = to 70%
* Life expectancy \> or = to 3 months
* Patients with treated brain metastases are eligible
* Required Laboratory Data Granulocytes \> 1,200/mm3 Platelet count \> 50,000/μl Hemoglobin ≥ 8 gm/dl BUN \< 1.5 times normal Serum creatinine \< 1.8 mg/dl Creatinine Cl ≥50 ml/mm (can be calculated utilizing the Cockcroft \& Gault equation: Creatinine Clearance (mL/min) = {(140 - Age)} x Wt \[kg\] (x 0.85 if Female}/ {72 x SCr \[mg/dL\]} Bilirubin \< 1.5 times normal ALT, AST and alkaline phosphatase \< 5 times upper normal Negative HIV Negaitve Hepatitis B surface antigen Negative Hepatitis C serology LVEF ≥ 45% at rest (MUGA or ECHO) PFT-FEV1, DLCO, and FVC ≥ 50% of predicted
* Negative serum test for pregnancy, unless male, prior hysterectomy, tubal ligation, or postmenopausal. (Note: postmenopausal is defined as age\>55 with amenorrhea for \>1 year or age \<55 years with amenorrhea for 2 years and FSH level within postmenopausal range of institutional parameters; patients requiring FSH level to determine menopausal status need not have this performed and may choose to proceed with serum pregnancy testing.)

Exclusion Criteria

* Patients with HER2 overexpression by immunohistochemistry (IHC) or overamplification by FISH are not eligible and are defined as follows: IHC staining of 3+ (uniform, intense membrane staining of \> 30% of invasive tumor cells), a fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus or a FISH ratio (HER2 gene signals to chromosome 17 signals) of more than 2.0.
* Patients with a history of another malignancy within 5 years of study entry are not eligible (except basal cell skin carcinoma and carcinoma-in-situ of the cervix).
* No serious medical or psychiatric illness which prevents informed consent or intensive treatment is allowed.
* Patients will be ineligible for treatment on this protocol if (prior to protocol entry):

  * There is a history of a recent myocardial infarction (within one year)
  * There is a history of a past myocardial infarction (more than one year ago) along with current coronary symptoms requiring medications and/or evidence of depressed left ventricular function (LVEF \< 45% by MUGA or ECHO)
  * There is a current history of angina/coronary symptoms requiring medications and/or evidence of depressed left ventricular function (LVEF \< 45% by MUGA or ECHO)
  * There is clinical evidence of congestive heart failure requiring medical management (irrespective of MUGA or ECHO results)
* Patients will be ineligible if there is recurrent pleural effusion or ascites requiring drainage (through thoracentesis, paracentesis, or indwelling device) more often than once every 4 weeks.
* Patients with clinical evidence of active CNS metastases are ineligible for therapy on this protocol.