Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    III What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Jacksonville, Florida: 13-006433
    • Rochester, Minnesota: 13-006433
  • NCT ID:

    NCT01901094
  • Sponsor Protocol Number:

    A011202

About this study

This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy alone in treating patients with node-positive breast cancer previously treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Pre-Registration Eligibility Criteria:

  • Patients ≥ 18 years of age
  • Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (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 fine needle aspiration (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 human epidermal growth factor receptor 2 (HER2) status by immunohistochemistry [IHC] or fluorescence in situ hybridization [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 Food and Drug Administration (FDA)-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an Institutional Review Board (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 sentinel lymph node (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 ductal carcinoma in situ [DCIS]). Lobular carcinoma in situ (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.
  • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1.
  • Required Pre-Registration Laboratory Values:
    • Serum or urine beta-human chorionic gonadotropin (ß-HCG)
    • Negative in women of child-bearing potential

Intra-Operative Registration/Randomization Criteria:

  • Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of neoadjuvant chemotherapy.
  • A minimum of 2 or a maximum of 6 sentinel nodes are identified and excised by the surgeon. Patients who do not have an identifiable sentinel lymph node will not proceed to Registration/Randomization.
  • At least one sentinel lymph node with a metastasis greater than 0.2 mm in greatest dimension identified on intra-operative pathologic assessment. Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+). Axillary lymph node dissection [ALND] is not to be performed prior to Registration/Randomization.

Post-Operative Registration/Randomization Criteria:

  • For cases where ALND has not been performed and one of the following is true:
    1. intra-operative evaluation of sentinel lymph node could not be/was not performed and final pathology identified a positive SLN with metastasis greater than 0.2 mm on hematoxylin and eosin stain (H & E) OR
    2. sentinel lymph node on intra-operative evaluation considered negative was found to be positive on final pathology (with metastasis greater than 0.2 mm on H & E).
  • Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of neoadjuvant chemotherapy.
  • At least one lymph node with a metastasis greater than 0.2 mm in greatest dimension identified by H&E staining on final pathology (for cases where intra-operative evaluation was not performed, or was negative and complete dissection was not performed).
  • Among the minimum of 2 and the maximum of 6 sentinel nodes identified and excised by the surgeon, no more than 8 lymph nodes (sentinel and non-sentinel) were found by the pathologists to have been actually excised. Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+).
  • For those patients who also undergo contralateral breast surgery, if invasive disease is found in the contralateral breast, the patient is not eligible for registration/randomization.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Judy Boughey, M.D.

Open for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Judy Boughey, M.D.

Open for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015