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

This is an interventional treatment trial for Breast Cancer focused on measuring HER2-negative breast cancer, stage IV breast cancer, recurrent breast cancer Read More

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.