October 8, 2020 Breast Neo-Adjuvant

Clinical Trial Information

Protocol: Alliance – A011202

SCHEMA A011202

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


Pre-registration requirements (Step 0)

  1. If the patient underwent SLN surgery (but not an ALND) where at least one lymph node (sentinel or non-sentinel) was identified on final pathology, to be positive for a metastasis greater than 0.2 mm in size, the patient may be pre-registered. Pre-registration must occur within 28 days of sentinel lymph node surgery

Registration requirements (Step 1)

  1. Registration to any required or optional companion studies will be done at the same time as registration/randomization to the treatment study. Registration to treatment and companion studies will not be completed if eligibility requirements are not met for all selected trials (treatment and companions). Patients who pre-register after SLN surgery are not eligible to participate in A011202-SI1 (since pre-SLN surgery arm measurements are not available). Therefore, patients who pre-register after SLN surgery will be unable to register to A011202-SI1.

Confirmation of Evaluability (Step 2)

  1. For all patients pre-registered after the release of Update #09, the Alliance Statistics and Data Center (SDC) will review source documentation submitted during the period between surgery and the end of radiation therapy for each patient. Evaluability will be determined based on the below criteria after the patient completes radiation therapy:
  • • Surgery was completed within 84 days after completion of neoadjuvant chemotherapy
    • Negative margins were achieved at surgery
    • No invasive disease was found in the contralateral breast
    • At least one positive lymph node with metastasis greater than 0.2 mm was identified at SLN surgery
    • No more than 8 lymph nodes (sentinel + non-sentinel) were seen on final pathology
    • Arm 1 only, after randomization: a minimum of 8 lymph nodes (SLN + ALND) were resected
    • Radiation therapy was initiated within 3-12 weeks after surgery

2.  cT Stage at Diagnosis:
1) Stages 1, 2
2) Stage 3
 Type of Surgery:
1) Lumpectomy
2) Mastectomy
Histologic Subtype at Diagnosis
1) Triple Negative: ER negative; PgR negative; HER2 negative

A tumor is considered HER2 negative if one of the following holds:
(a) 2+ by IHC and ISH negative
(b) IHC: 0 or 1+ and ISH: negative or not performed
2) HER2 positive
A tumor is considered HER2 positive if 3+ by IHC or ISH positive
3) ER and/or PgR positive; HER2 negative



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