Page 12 - Delaware Medical Journal - November 2016

CANCER CLINICAL TRIAL
NCI PROTOCOL OF THE MONTH
Alliance A011202: A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who
Have Positive Sentinel Lymph Node Disease After Neoadjuvant
Chemotherapy The objectives of the trial are:
Pimary Objective:
To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy.
Secondary Objective:
To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy.
Correlative Objectives:
To estimate the incidence of arm lymphedema. To estimate the incidence of breast lymphedema for patients who underwent breast

Pre-Registration Eligibilty Criteria:
1. Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy).
2. All patients must have had an axillary ultrasound with FNA or core needle biopsy of axillary lymph nodes documenting axillary
metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy.
3. Patients must have had estrogen receptor, progesterone receptor and HER2 status (by IHC and/or ISH) evaluated on diagnostic
core biopsy prior to start of neoadjuvant chemotherapy.
4. Patients must have completed all chemotherapy prior to surgery. Sandwich chemotherapy is not allowed (i.e. chemotherapy
planned to be given after surgery). Patients must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of
an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes.
5. Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, or trastuzumab + pertuzumab, or other
approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen). Therapy must be FDA-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an IRB-approved clinical trial.
6. All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy.
7.
Treatment:
Arm 1: Axillary lymph node dissection + nodal radiation therapy (without XRT to dissected axilla)
Surgery: For patients randomized to ALND, it is recommended that a complete level I and II dissection with resection of minimum of a surgeon.
Radiation therapy: Radiation is delivered to the breast/chest wall, undissected axilla, supraclavicular nodes and internal mammary nodes
Note: If fewer than 8 lymph nodes (SLN and ALND together) are resected, then the patient will discontinue protocol treatment .
Arm 2: Axillary radiation and nodal radiation therapy only
Radiation therapy: Radiation is delivered to the breast/chest wall, full axilla including Levels I, II, III, supraclavicular nodes and internal
The Delaware Cancer Treatment Program (DCTP) provides medical insurance coverage to uninsured Delawareans for the treatment of cancer. Call 302-744-1040 for more information.
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
332 Del Med J | November 2016 | Vol. 88 | No. 11