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

Summary

Treatment arms:
arm 1: axillary lymph node dissection + nodal radiation therapy
Surgery: For patients randomized to aLnD, it is recommended that a complete level i and ii dissection with resection of minimum of a total of 8 lymph nodes (SLn and aLnD together) be done.
Radiation therapy: Treatment will be given 5 days a week over 5 x 6 weeks.

arm 2: axillary and nodal radiation therapy only
Radiation therapy: Treatment will be given 5 days a week over 5 x 6 weeks.

Participant Eligibility


* Patients > 18 years of age.

* Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant
chemotherapy) by AJCC staging 7th edition.

* No inflammatory breast cancer.

* No other malignancy within 5 years of registration with the exception of basal cell or
squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ
of the cervix.

* 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 neoadjuvant chemotherapy.

* Patients must have had estrogen receptor, progesterone receptor and HER2 status (by IHC or FISH) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy.

* Patients must have completed all planned chemotherapy prior to surgery. Sandwich
chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery).

* Patients must have completed at least 6 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.

* Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab,
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.

* All patients must have a clinically negative axilla (no palpable lymph nodes or bulky
adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy.

* No neoadjuvant endocrine therapy.

* No neoadjuvant radiation therapy.

* No SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to
or during neoadjuvant chemotherapy.

* No prior history of ipsilateral breast cancer (invasive disease or DCIS). LCIS and benign
breast disease is allowed.

* No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or
treatment of hidradenitis.

* No history of prior or concurrent contralateral invasive breast cancer. Benign breast
disease, LCIS or DCIS of contralateral breast is allowed.

* Patients must not be pregnant or nursing. A negative pregnancy test is required prior to
registration for women of childbearing potential.

Note: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of
childbearing potential.

* ECOG (Zubrod) Performance Status 0-1.

* Required pre-registration laboratory values: