October 8, 2020 Breast Neo-Adjuvant

Clinical Trial Information

Schema A011202

Protocol: Alliance – A011202

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

Eligibility:

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

 

 



April 8, 2020 Breast Neo-Adjuvant

Clinical Trial Information

Schema NSABP B-51

PROTOCOL: NSABP-B-51 – RTOG-1304

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

ELIGIBILITY:

  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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