Trial Search Results

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

This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Procedure: Axillary Lymph Node Dissection (ALND)
  • Radiation: Nodal Radiation Therapy
  • Radiation: Axillary Radiation Therapy

Phase:

Phase 3

Eligibility


Pre-Registration Eligibility Criteria:

   1. Patients ≥ 18 years of age

   2. 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

   3. No inflammatory breast cancer

   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

   5. 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 or at most 14 days after starting neoadjuvant chemotherapy.
   Note: Biopsy of intramammary nodes does not fulfill eligibility criteria.

   6. Patients must have had estrogen receptor, progesterone receptor and human epidermal
   growth factor receptor 2 (HER2) status by immunohistochemistry [IHC] and/or
   fluorescence in situ hybridization [FISH] evaluated on diagnostic core biopsy prior to
   start of neoadjuvant chemotherapy. Note: If HER2 status has not been clearly
   determined (ie equivocal/indeterminate), then patients should not be enrolled.

   7. 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 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. NOTE: Delays/dose modifications due to
   toxicities/adverse events are allowed as long as a minimum of 4 cycles of neoadjuvant
   chemotherapy is administered. More than 4 cycles of NAC may be administered at the
   discretion of the treating medical oncologist.

   8. 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 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.

   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
   chemotherapy. NOTE: An ultrasound of the axilla is not required at completion of
   neoadjuvant chemotherapy. If performed, its findings do NOT impact eligibility.

10. No neoadjuvant endocrine therapy

11. No neoadjuvant radiation therapy

12. No sentinel lymph node (SLN) surgery/excisional biopsy for pathological confirmation
   of axillary status prior to or during neoadjuvant chemotherapy

13. 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.

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

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

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.

17. Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1.

18. 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:

   1. Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be
   completed within 56 days of the completion of neoadjuvant chemotherapy.

   2. A minimum of 1 sentinel node and a maximum of 6 total nodes (sentinel + non-sentinel)
   are identified and excised by the surgeon. Patients who do not have an identifiable
   sentinel lymph node will not proceed to Registration/Randomization.

   3. At least one lymph node (sentinel or non-sentinel) 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:

1. For cases where ALND has not been performed and one of the following is true:

   - intra-operative evaluation of sentinel lymph node could not be/was not performed and
   final pathology identified a positive lymph node (sentinel or non-sentinel) with
   metastasis greater than 0.2 mm on hematoxylin and eosin stain (H & E) OR

   - lymph node (sentinel or non-sentinel) considered negative on intra-operative
   evaluation 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 (sentinel or non-sentinel) 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
      completion dissection was not performed).

      - Among the minimum of 1 and the maximum of 6 nodes (sentinel or non-sentinel)
      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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting