Limited stage disease patients, with disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes* Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes are not eligible* Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are not eligible unless they have a negative thoracentesis* Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray, are not eligible
If radiologic evaluation of a lymph node is interpreted as positive, this must be evaluated further either by lymphadenectomy or by percutaneous needle biopsy; patients with histologically or cytologically confirmed node metastases will not be eligible
Evidence of distant metastases or histologically or cytologically proven lymph node metastases
Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph nodes dissection (ALND); patients must have at least one, but no more than three known positive lymph nodes (pN1a, pN1b or pN1c); patients with micrometastases as the only nodal involvement (pN1mi) are not eligible; patients with positive sentinel node are not required to undergo full axillary lymph node dissection; this is at the discretion of the treating physician; axillary node evaluation is to be performed per the standard of care at each institution
Patients status post a negative lymph node dissection are not eligible
Surgical axillary staging procedure prior to first definitive breast operation; Note: fine-needle aspiration (FNA) or core needle biopsy of axillary node is permitted
Patients must be high risk by belonging to one of the following risk groups:* Completion of adjuvant chemotherapy and pathologically negative lymph nodes, and a tumor measuring >= 2 cm in greatest diameter, and an Oncotype DX recurrence score > 25 (completed as standard of care) or a MammaPrint assay (completed as standard of care) in the high-risk category; patients with micrometastases as the only nodal involvement (pN1mi) are eligible, and will be categorized as node-negative * Completion of adjuvant chemotherapy, and pathologically 1-3 positive lymph nodes, and either an Oncotype DX recurrence score > 25, MammaPrint assay in the high-risk category (completed as standard of care), or tumor tissue with pathological grade III following local practice; if Oncotype DX is done, then RS must be > 25, similarly if the MammaPrint assay is performed it has to be high-risk; if the test is not done, but the patient has grade III disease then the patient is eligible and Oncotype DX or MammaPrint does not need to be performed* Completion of adjuvant chemotherapy and pathologically 4 or more positive lymph nodes* Completion of neoadjuvant chemotherapy and 1 or more positive nodes pathologically determined after chemotherapy* NOTE: patients who receive both the neoadjuvant and adjuvant chemotherapy may be registered in the neoadjuvant therapy risk group, provided they meet all the criteria above for that risk group* NOTE: in the lymph node positive groups, at least one metastasis >= 2.0 mm must be present; patients with micrometastases as the only nodal involvement (pN1mi) are eligible and will be categorized as node-negative
Patients must have undergone axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND)* For patients with 1-3 positive lymph nodes, sentinel node biopsy alone is allowed provided that the patient completed either whole breast or chest wall radiation and the primary tumor is < 5 cm* All patients with >= 4 positive lymph nodes must have completed ALND (with or without prior sentinel node biopsy)
Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive fine needle aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma); the FNA or core needle biopsy can be performed either by palpation or by image guidance; documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted
At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer; acceptable procedures for assessment of axillary nodal status at the time of surgery include:* Axillary node dissection* Sentinel node biopsy alone provided that at least 2 sentinel lymph nodes are removed; removal of at least 3 sentinel lymph nodes and use of dual tracer for lymphatic mapping are strongly recommended or* Sentinel node biopsy followed by axillary node dissectionNote: patients are eligible whether there is residual invasive carcinoma in the surgical breast specimen or whether there is evidence of pathologic complete response; patients who are found to be pathologically node-positive at the time of surgery, based on sentinel node biopsy alone, are candidates for A011202, a study developed by the Alliance in Oncology, an National Cancer Institute (NCI) Cooperative Group; if A011202 is open at the investigator's institution, patients should be approached about participating in the A011202 study
Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone
Patients with histologically positive axillary nodes post neoadjuvant therapy
Contralateral hilar node involvement
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
No SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy
No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis
Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of the last dose of neoadjuvant chemotherapy
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
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+)* Note: If on final pathology, more than 8 lymph nodes are seen pathologically, then the patient should discontinue study* Axillary lymph node dissection (ALND) is not to be performed prior to registration/randomization
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 lymph node (sentinel or non-sentinel) with metastasis greater than 0.2 mm OR 2) 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)
Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of the last dose of neoadjuvant chemotherapy; negative margin (by either breast conservation or mastectomy) on final pathology where negative margin is defined as no tumor on ink
At least one lymph node (sentinel or non-sentinel) with a metastasis greater than 0.2 mm in greatest dimension identified 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 lymph nodes (sentinel + 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+)
Surgical axillary staging procedure prior to study entry; Note: fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted
Completed adequate axilla surgery defined as:* ADJUVANT CHEMOTHERAPY PATIENTS:** Sentinel lymph node biopsy alone if negative or if lymph node(s) only contain micrometastases (=< 2.0 mm) OR ** Positive sentinel lymph node biopsy followed by axillary nodal dissection or radiotherapy as per local guidelines OR** Axillary dissection* NEOADJUVANT CHEMOTHERAPY PATIENTS:** Sentinel lymph node biopsy performed before neoadjuvant chemotherapy:*** If negative or if lymph node(s) only contain micrometastases (=< 2.0 mm), additional axillary surgery is not required*** If positive, axillary node dissection or axillary nodal radiotherapy should follow completion of neoadjuvant chemotherapy** Sentinel lymph node biopsy performed after neoadjuvant chemotherapy:*** If negative, additional axillary surgery not mandated*** If positive (micrometastases are regarded as positive), additional axillary surgery is required unless the patient is enrolled in a phase III multicenter clinical trials proposing radiotherapy as alternative treatment of the axilla; the trial must be pre-approved by the OlympiA Executive Committee** Axillary dissection
Number of allowable metastases:* =< 4 metastases seen on standard imaging within 60 days prior to registration when all metastatic disease is located within the following sites:** Peripheral lung ** Osseous (bone)** Spine** Central lung** Abdominal-pelvic metastases (lymph node/adrenal gland)** Liver** Mediastinal/cervical lymph node
Must have completed definitive resection of primary tumor* Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however patients with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy; patients with margins positive for lobular carcinoma in situ (LCIS) are eligible* Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable* Sentinel node biopsy either pre or post neoadjuvant chemotherapy (i.e. at the time of definitive surgery) are allowed; axillary dissection is encouraged in patients with lymph node involvement, but is not mandatory
The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below.* Sentinel lymphadenectomy alone:** If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b;** If pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1a and the patient has undergone breast conserving surgery (with planned breast radiotherapy), the primary tumor must be T1 or T2 by pathologic evaluation and the nodal involvement must be limited to 1 or 2 positive nodes* Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or* Axillary lymphadenectomy with or without SN isolation procedure
All subjects (both adjuvant and neoadjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection, as per pre-specified institutional guidelines
Pathologically proven to be lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [pNx])
Stage:* any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0, or;* any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0, or;* any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0
It is preferred that axillary lymph node sampling is performed after completion of neoadjuvant chemotherapy to allow more accurate assessment of pathologic response; patients must have a complete axillary lymph node dissection after neoadjuvant chemotherapy in the following situations (exceptions will be granted for patients participating in the Alliance A11202 trial):* Patients had documented pathologic involvement of the axillary nodes (fine needle aspiration [FNA] or core biopsy) before neoadjuvant chemotherapy and had sentinel node biopsy after neoadjuvant chemotherapy with positive sentinel node(s)* Patient had documented pathologic involvement of the axillary nodes (FNA or core biopsy) before neoadjuvant chemotherapy and had only 1 sentinel lymph node removed after neoadjuvant chemotherapy** NOTE: Patients who undergo sentinel node biopsy before starting neoadjuvant treatment and do not undergo post neoadjuvant assessment of the axillary nodes or who have negative axillary nodes on post neoadjuvant assessment must have >= 1 cm residual invasive cancer in the breast after completion of neoadjuvant chemotherapy
One of the following pathologic N-classifications: pN0, pNX* If a lymph node dissection is performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator versus (vs.) extended lymph node dissection) should be noted whenever possible