An Open Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER-2 Negative Breast Cancer Patients Selected with a Test Measuring Live Cell HER2 Signaling Transduction (FACT 1)

August 1, 2022

Protocol: NSABP-FB-12

SCHEMA FB-12

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!

Patient Guidelines:

  1. Medical oncologist has indicated the intention to administer doxorubicin/cyclophosphamide followed by paclitaxel.
  2. Co-morbid conditions should be taken into consideration, but not the diagnosis of breast cancer.
  3. 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

Eligibility:

  1. Patients must be female.
  2. Patients must be ≥ 18 years old.
  3. Patient must have an ECOG performance status of 0 or 1.
  4. The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
  5. The primary breast tumor must be palpable and measure ≥ 2.0 cm on physical exam.
  6. The regional lymph nodes can be cN0, cN1, or cN2a.
  7. Histological grade II or III tumor.
  8. 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.
  9. 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.

Ineligibility:

  1. T4 tumors including inflammatory breast cancer.
  2. FNA alone to diagnose the breast cancer.
  3. Excisional biopsy or lumpectomy performed prior to initiating chemotherapy.
  4. Surgical axillary staging procedure prior to initiating chemotherapy. Pre-neoadjuvant therapy sentinel node biopsy is not permitted. (FNA or core biopsy is acceptable.)
  5. Definitive clinical or radiologic evidence of metastatic disease. Required imaging studies must have been performed within 6 weeks prior to initiating chemotherapy.
  6. Synchronous bilateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
  7. Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
  8. Previous therapy with anthracycline, taxanes, trastuzumab, or other HER2 targeted therapies for any malignancy.
  9. 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.

Genesys Hurley Cancer Institute

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