Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!
- Medical oncologist has indicated the intention to administer doxorubicin/cyclophosphamide followed by paclitaxel.
- Co-morbid conditions should be taken into consideration, but not the diagnosis of breast cancer.
- All patients will be required to have a research core biopsy procedure to procure fresh tumor tissue for pre-entry central HER2 signaling testing by Celcuity
- Patients must be female.
- Patients must be ≥ 18 years old.
- Patient must have an ECOG performance status of 0 or 1.
- The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
- The primary breast tumor must be palpable and measure ≥ 2.0 cm on physical exam.
- The regional lymph nodes can be cN0, cN1, or cN2a.
- Histological grade II or III tumor.
- Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 6 weeks prior to initiating chemotherapy. If suspicious or abnormal, FNA or core biopsy is recommended, also within 6 weeks prior to initiating chemotherapy. Findings of these evaluations will be used to determine the nodal status prior to initiating chemotherapy.
- Tumor specimen obtained at the time of diagnosis must have ER and PgR analysis assessed by current ASCO/CAP Guidelines. Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors. Tumor specimen obtained at the time of diagnosis must have been determined to be HER2-negative.
- T4 tumors including inflammatory breast cancer.
- FNA alone to diagnose the breast cancer.
- Excisional biopsy or lumpectomy performed prior to initiating chemotherapy.
- Surgical axillary staging procedure prior to initiating chemotherapy. Pre-neoadjuvant therapy sentinel node biopsy is not permitted. (FNA or core biopsy is acceptable.)
- Definitive clinical or radiologic evidence of metastatic disease. Required imaging studies must have been performed within 6 weeks prior to initiating chemotherapy.
- Synchronous bilateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
- Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
- Previous therapy with anthracycline, taxanes, trastuzumab, or other HER2 targeted therapies for any malignancy.
- History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 2 years prior to initiating chemotherapy.