April 8, 2020 Breast Neo-Adjuvant

Clinical Trial Information



Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.


  1. The patient must be female and must be ≥ 18 years old.
  2. The patient must have an ECOG performance status of 0 or 1.
  3. Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy). Clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, MRI, PET scan, or PET/CT scan.
  4. Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma).
    The FNA or core needle biopsy can be performed either by palpation or by image guidance. Documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted.
  5. Patients must have had ER analysis performed on the primary breast tumor before neoadjuvant therapy. If negative for ER, assessment of PgR must also be performed .
  6. Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy. Patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible.
  7. Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen.
  8. 0 For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization. (If treatment delays occur, chemotherapy must be completed within
    14 weeks.) The dose and schedule of the adjuvant chemotherapy are at the investigator’s discretion. Note: It is preferred that all intended chemotherapy be administered in the neoadjuvant setting.
  9. Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.
  10. At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer.
  11. Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible.
  12. Patient who have undergone either a total mastectomy or a lumpectomy are eligible. (Patients who have had a nipple-sparing mastectomy are eligible.).
  13. For patients who undergo lumpectomy, the margins of the resected specimen or reexcision must be histologically free of invasive tumor and DCIS as determined by the local pathologist. Additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.).
  14. For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor.
  15. The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 70 days. Also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization
    must be no more than 70 days.
  16.  No definitive clinical or radiologic evidence of metastatic disease.
  17.  No T4 tumors including inflammatory breast cancer.
  18.  No N2 or N3 disease detected clinically or by imaging.
  19. Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node
    biopsy alone is an ineligibility.
  20.  No histologically positive axillary nodes post neoadjuvant therapy.
  21.  No microscopic positive margins after definitive surgery.
  22.  No synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with
    synchronous and/or previous contralateral LCIS are eligible.)
  23.  No radiation therapy for the currently diagnosed breast cancer prior to randomization.
  24.  No prior breast or thoracic RT for any condition.

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Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium


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