A011202: A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3N1) Who Have Positive sentinel Lymph Node Disease after Neoadjuvant Chemotherapy

Study ID
STU 092013-073

Cancer Related

Healthy Volunteers

Study Sites

  • Zale Lipshy University Hospital

J Susan Armstrong

Principal Investigator
Ann Leitch


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. Level iii dissection is not required, but may be performed at the discretion of the surgeon.
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

4.1.1 Patients > 18 years of age.
4.1.2 Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by AJCC staging 7th edition.
4.1.3 No inflammatory breast cancer.
4.1.4 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.
4.1.5 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.
Note: Biopsy of intramammary nodes does not fulfill eligibvility criteria.
4.1.6 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.
Note: If HER2 status has not been clearly determined (i.e. equivocal/indeterminate), then patients should not be enrolled.
4.1.7 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 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.
Note: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of 6 cycles of neoadjuvant chemotherapy is administered. More than 6 cycles of NAC may be administered at the discretion of the treating medical oncologist.
4.1.8 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.
4.1.9 All patients must have a clinically negative axilla (no palpable lymph nodes or bulky
adenopathy) on physical examination documented at the completion of neoadjuvant
Note: An ultrasound of the axilla is not required at completion of neoadjuvant
chemotherapy. If performed, its findings do NOT impact eligibility.
4.1.10 No neoadjuvant endocrine therapy.
4.1.11 No neoadjuvant radiation therapy.
4.1.12 No SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to
or during neoadjuvant chemotherapy.
4.1.13 No prior history of ipsilateral breast cancer (invasive disease or DCIS). LCIS and benign
breast disease is allowed.
4.1.14 No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or
treatment of hidradenitis.
4.1.15 No history of prior or concurrent contralateral invasive breast cancer. Benign breast
disease, LCIS or DCIS of contralateral breast is allowed.
4.1.16 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.
4.1.18 Required pre-registration laboratory values:
Serum or urine [BETA]-HCG Negative in women of child-bearing potential