Breast imaging should include imaging of the ipsilateral axilla; for subjects with a clinically negative axilla, a sentinel lymph node biopsy will be performed either up front or after preoperative therapy at the discretion of the subject’s physicians; for subjects with a clinically positive axilla, a needle aspiration, core biopsy or sentinel lymph node (SLN) procedure will be performed prior to registration to confirm the presence of metastatic disease in the lymph nodes; while not mandated by the protocol, it is strongly recommended that participants with positive lymph nodes undergo a level I and II lymph node dissection at the time of definitive surgery; participants with axillary adenopathy only are not eligible for this study
All subjects (both adjuvant and neoadjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection, as per pre-specified institutional guidelines
Patients must have undergone axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND)\r\n* 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\r\n* All patients with >= 4 positive lymph nodes must have completed ALND (with or without prior sentinel node biopsy)
The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below.\r\n* Sentinel lymphadenectomy alone:\r\n** If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b;\r\n** 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\r\n* Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or\r\n* Axillary lymphadenectomy with or without SN isolation procedure
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\r\n* Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+)\r\n* Note: If on final pathology, more than 8 lymph nodes are seen pathologically, then the patient should discontinue study\r\n* 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; \r\n* Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+)
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:\r\n* Axillary node dissection\r\n* 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\r\n* Sentinel node biopsy followed by axillary node dissection\r\nNote: 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
Completed adequate axilla surgery defined as:\r\n* ADJUVANT CHEMOTHERAPY PATIENTS:\r\n** Sentinel lymph node biopsy alone if negative or if lymph node(s) only contain micrometastases (=< 2.0 mm) OR \r\n** Positive sentinel lymph node biopsy followed by axillary nodal dissection or radiotherapy as per local guidelines OR\r\n** Axillary dissection\r\n* NEOADJUVANT CHEMOTHERAPY PATIENTS:\r\n** Sentinel lymph node biopsy performed before neoadjuvant chemotherapy:\r\n*** If negative or if lymph node(s) only contain micrometastases (=< 2.0 mm), additional axillary surgery is not required\r\n*** If positive, axillary node dissection or axillary nodal radiotherapy should follow completion of neoadjuvant chemotherapy\r\n** Sentinel lymph node biopsy performed after neoadjuvant chemotherapy:\r\n*** If negative, additional axillary surgery not mandated\r\n*** 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\r\n** Axillary dissection
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):\r\n* 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)\r\n* 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\r\n** 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
Complete resection of known breast disease by one of the following surgeries:\r\n* Lumpectomy with sentinel lymph node or axillary lymph node dissection\r\n* Mastectomy alone with sentinel lymph node or axillary lymph node dissection\r\n* Mastectomy plus reconstruction with sentinel lymph node or axillary lymph node dissection
Previous excisional biopsy of the breast cancer or sentinel lymph node biopsy
Surgical axillary staging procedure prior to randomization. Exception: FNA or core biopsy of an axillary node is permitted for any patient. A pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is prohibited.
Participant agreement to undergo appropriate surgical management including axillary lymph node surgery and partial or total mastectomy after completion of neoadjuvant treatment
Axillary lymph node dissection prior to initiation of neoadjuvant therapy
pStage T1-T4N0-N3M0 or ypStage T0-4N0-N3M0\r\n* Note: The axilla must be staged by sentinel node biopsy alone, sentinel node biopsy followed by axillary node dissection, or axillary lymph node dissection alone
Phase II: No prior chemotherapy, irradiation, or definitive therapeutic surgery (e.g., mastectomy or lumpectomy or axillary dissection) for this malignancy; patients who have had a prior sentinel lymph node biopsy for this malignancy are eligible
INCLUSION - TREATMENT: Patients are required to undergo lumpectomy with sentinel lymph node biopsy
Patients must have a negative sentinel lymph node biopsy
Phase I: patients must be candidates to receive paclitaxel chemotherapy in combination with trastuzumab and pertuzumab\r\n* Phase II: no prior chemotherapy, radiation, or definitive therapeutic surgery (e.g., mastectomy, lumpectomy or axillary dissection) for this malignancy; patients who have had a prior sentinel lymph node biopsy for this malignancy are eligible\r\n* Note: patients who receive equal to or less than 1 cycle of therapy (up to 4 weeks) will be allowed to enroll on this trial
Breast imaging should include imaging of the ipsilateral axilla; for subjects with a clinically negative axilla, a sentinel lymph node biopsy will be performed either before or after preoperative therapy at the discretion of the subject’s physicians; for subjects with a clinically positive axilla, a needle aspiration, core biopsy or sentinel lymph node (SLN) procedure will be performed to determine the presence of metastatic disease in the lymph nodes
Treatment with mastectomy or segmental mastectomy and axillary evaluation (sentinel node evaluation, axillary sampling, or axillary lymph node dissection); if the patient has T0 disease, breast surgery is not required
Patients with invasive disease are required to have axillary staging including: sentinel node biopsy alone if sentinel node is negative, sentinel node biopsy followed by axillary dissection with a minimum of 6 axillary nodes sampled if sentinel node is positive, or axillary dissection alone (with a minimum of 6 axillary nodes); patients with DCIS are not required to have axillary staging
Patients must be eligible to undergo surgery, either lumpectomy or mastectomy for local treatment of the breast cancer; surgical margins at discretion of surgeon per National Comprehensive Cancer Network (NCCN) guidelines; axillary exploration at discretion of surgeon but all patients minimally have sentinel lymph node evaluation at time of surgery
Prior axillary lymph node sampling (sentinel lymph node biopsy or axillary lymph node dissection); fine needle aspiration (FNA) of axillary lymph node is acceptable
Sentinel lymph node biopsy
Patients with clinically suspicious axillary lymph node involvement must have either aspiration cytology or biopsy prior to beginning therapy
No prior chemotherapy, irradiation, or definitive therapeutic surgery (eg, mastectomy or lumpectomy or axillary dissection) for this malignancy; patients who have had a prior sentinel lymph node biopsy for this malignancy are eligible
Patients must be node-negative (N0) or have only microscopic disease (=< 2 mm) in the nodes (N1mi); patients are required to have axillary staging; options for axillary staging include:\r\n* Negative sentinel lymph node biopsy (SLNB)\r\n* Level I-II axillary lymph node dissection (ALND) (6 or more nodes removed)\r\n* Positive SLNB followed by completion ALND (6 or more nodes removed)
Must be Stage 0, I, II (Tis, T1, or T2, N0, M0 per AJCC criteria 7th and/or 8th Ed.). If stage II, the tumor size must be < = 3.0 cm. A patient with invasive histology must have nodal stage pN0 by H&E stains on sentinel node biopsy or axillary lymph node dissection.
Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes); axillary staging is not required for patients with DCIS
Patients with a breast cancer diagnosis of any subtype and a biopsy-proven positive axillary lymph node who will be treated first with chemotherapy
Patients who have had previous axillary surgery, including sentinel lymph node biopsy
The patient must have undergone either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) demonstrating pathologic node-negativity (pN0); however, patients with immunohistochemical evidence of isolated tumor cells in a lymph node [pN0(i+)] are eligible if no deposit > 0.2 mm is identified
Patients who underwent partial excisional biopsy or lumpectomy, segmental mastectomy or modified radical mastectomy or sentinel node biopsy are not eligible
Participants must have a minimum of two intact lymph node basins (any combination of axillary and inguinal basins that have not undergone complete nodal dissection)
Participants does not have a minimum of two intact lymph node basins (any combination of axillary and inguinal basins that have not undergone complete nodal dissection)
Positive axillary node(s)
Surgical axillary staging procedure prior to randomization; pre-neoadjuvant therapy sentinel node biopsy is not permitted
Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (tumors < 5 mm in size do not require nodal assessment) or after mastectomy
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
Breast imaging should include imaging of the ipsilateral axilla; for subjects with a clinically negative axilla, a sentinel lymph node biopsy will be performed either before or after preoperative therapy at the discretion of the subject’s physicians; for subjects with a clinically positive axilla, a needle aspiration, core biopsy or sentinel lymph node (SLN) procedure will be performed to determine the presence of metastatic disease in the lymph nodes
Adequate surgical treatment including resection of all clinically evident disease and ipsilateral axillary lymph node dissection. Histologically complete resection (R0) of the invasive and ductal in situ tumor is required in case of breast conserving surgery as the final treatment. No evidence of gross residual disease (R2) is required after total mastectomy (R1 resection is acceptable). Axillary dissection is not required in patients with a negative sentinel-node biopsy before (pN0, pN+(mic)) or after (ypN0, ypN+(mic) neoadjuvant chemotherapy.
For Cohort A: include patients who have undergone sentinel lymph node biopsy (SLNB) without completion axillary lymph nodal dissection (ALND)
Status post segmental mastectomy or mastectomy and axillary node dissection with removal of at least 8 nodes
Axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy
Patients with DCIS do not require an axillary staging procedure; for patients with invasive breast cancer (except T1mi), an axillary staging procedure should be performed (either sentinel lymph node biopsy alone or axillary dissection and the axillary node must be pathologically negative) and they should be pathologically node negative; Note: Patients with N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e., if the tumor deposit is 0.2 mm or less as determined by immunohistochemistry or hematoxylin and eosin staining) will also be eligible
Stage I-III breast cancer with the following criteria met:\r\n* If node-negative or if node status unknown (because it was not assessed), tumor must be > 5 mm (T1b) of any hormone receptor subtype (document estrogen receptor/progesterone receptor [ER/PR] status: if some ER/PR staining is present, ER and PR negative are defined as being positive in < 10% cells [per local pathology read])\r\n* If node-positive (N1-N3), T1mi, T1a, T1b, T1c, T2, or T3 tumors are eligible\r\n** Definition of node-negative disease (when node status known): If the patient has had a negative sentinel node biopsy and/or a negative axillary dissection, then the patient is determined to be node-negative; axillary nodes with single cells or tumor clusters =< 0.2 mm by either hematoxylin and eosin (H&E) or IHC will be considered node-negative; any axillary lymph node with tumor clusters between 0.02 and 0.2 cm is considered a micrometastasis; patients with a micrometastasis are eligible; an axillary dissection is not required to be performed in patients with a positive sentinel node and management of the axilla will be left up to the treating provider; in cases where the specific pathologic size of lymph node involvement is subject to interpretation, the principal investigator will make the final determination as to eligibility; in these special situations, the investigator must document this approval in the patient medical record
Randomisation and the primary study intervention, including staging sentinel node biopsy, must be completed by 120 days of original diagnosis.
Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion.
Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including sentinel lymph node biopsy, of the index melanoma.
Patients who underwent partial excisional biopsy, lumpectomy, segmental mastectomy, modified radical mastectomy or sentinel node biopsy and, therefore cannot be assessed for pathologic response accurately
Patients must have HER2-positive stage I histologically confirmed invasive carcinoma of the breast; patients must have node-negative (N0) or micrometastases (N1mi) breast cancer according to the American Joint Committee on Cancer (AJCC) 7th edition\r\n* If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative; if an axillary dissection, without sentinel lymph node biopsy is performed to determine nodal status, at least 6 axillary lymph nodes must be removed and analyzed and negative for the patient to be considered node-negative; axillary nodes with single cells or tumor clusters =< 0.2 mm by either hematoxylin and eosin (H&E) or immunohistochemistry (IHC) will be considered node-negative\r\n* Any axillary lymph node with tumor clusters between 0.02 and 0.2 cm is considered a micrometastasis; patients with a micrometastasis are eligible; an axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation; in cases where the specific pathologic size of lymph node involvement is subject to interpretation, the principal investigator will make the final determination as to eligibility; the investigator must document approval in the patient medical record\r\n* Patients who have an area of a T1aN0, estrogen receptor positive (ER+), HER2 negative cancer in addition to their primary Her2 positive tumor are eligible
Eligible patients must have appropriate staging studies identifying them as American Joint Committee on Cancer (AJCC) stage T0 , T1 or T2 (=< 3 cm) treated with lumpectomy and axillary node dissection with at least 6 nodes sampled or sentinel node biopsy; patients with up to 3 positive nodes without microscopic or macroscopic evidence of extracapsular extension are eligible; patients with DCIS are not required to have axillary staging
Prior axillary lymph node sampling (sentinel lymph node biopsy or axillary lymph node dissection); NOTE: fine needle aspiration (FNA) of axillary lymph node is acceptable
Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.
Participants who have undergone excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy
At least 6 months postop from axillary lymph node dissection
Bilateral lymphedema or history of bilateral axillary lymph node dissection
Patients undergoing unilateral mastectomy with or without sentinel node biopsy or axillary dissection
Prior surgery including lumpectomy or mastectomy and sentinel node biopsy or axillary lymph node dissection
Scheduled to undergo one of the following elective breast cancer surgery at Barnes-Jewish Hospital: axillary dissection, modified radical mastectomy, mastectomy with same day reconstruction, sentinel lymph node biopsy (SLNB), partial mastectomy with SLNB, or simple mastectomy with SLNB
Previous surgery other than lumpectomy or sentinel lymph node biopsy on the surgical breast or axilla
Female clinical stage 0/1 breast cancers patients scheduled to undergo a unilateral, segmental mastectomy +/- sentinel lymph node dissection
Mastectomy type: skin-sparing or nipple-sparing mastectomy with or without sentinel lymph node biopsy; may be unilateral or bilateral mastectomy
Clinically N0 or pN0 including sentinel node negative
Unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)
All patients with a history of breast cancer surgery either lumpectomy, mastectomy, axillary node dissection or sentinel node biopsy at least one year ago and received either radiation therapy or chemotherapy or both
Status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive PMRT
Total mastectomy and axillary staging with sentinel lymph node dissection or axillary lymph node dissection (level I/II). Patients with a positive sentinel lymph node must have undergone a completion axillary lymph node dissection.
Breast conserving surgery (BCS) and axillary staging with sentinel lymph node dissection or axillary lymph node dissection. Patients undergoing surgery as a first intervention with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes. Patients receiving neoadjuvant chemotherapy that have a positive sentinel lymph node must have undergone a completion axillary lymph node dissection.
One of these 2 surgical treatments and axillary staging with sentinel lymph node dissection or axillary dissection level I/II:
Total mastectomy-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II
BCS (lumpectomy)-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes
Patients not consenting to axillary lymph node dissection (ALND)
Patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous malignancies, or oral cavity squamous cell carcinoma, that are candidates for sentinel lymph node biopsy\r\n* Newly diagnosed with clinically node negative head and neck cancer being staged with sentinel lymph node biopsy
Axillary lymph node metastasis with pathologic confirmation by needle biopsy
Clip placed in the sampled axillary lymph node at the time of the biopsy
Scheduled for targeted axillary dissection (defined as selective localization and removal of the clipped node and sentinel lymph node dissection [SLND])
Participant must be eligible for a groin sentinel lymph node (SLN) biopsy
Sentinel lymph node is deemed inaccessible to microscopic observation during the operative procedure (i.e. sentinel node maps to a deep location or area outside of the groin)
Participants must have undergone sentinel node mapping or axillary dissection
Participants who have evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion
Participants must have histologically confirmed melanoma and be deemed an appropriate surgical candidate with consent for a sentinel lymph node biopsy by their oncologic surgeon
Participant must have stage of disease conducive to sentinel lymph node biopsy as determined by his or her oncologic surgeon
Participants who choose not to proceed with sentinel lymph node biopsy
Patients with a confirmed diagnosis of clinical stage 1 or 2 breast cancer who are undergoing breast cancer surgery with lumpectomy or mastectomy and planned axillary sentinel node biopsy procedure will be eligible for the study
Tumor is accessible for local injection of the sentinel node tracer (for example oral cavity disease)
Has had previous sentinel lymph node biopsy
Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph node(s), treatment of hidradenitis
Have had a previous ipsilateral axillary dissection or lymph node biopsy
Subjects scheduled for surgical intervention, with a sentinel lymph node biopsy procedure being a part of the surgical plan.
Prior axillary lymph node surgery
Will have administration of methylene blue or any blue dye for sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the LUM Imaging Device.
Patients who have undergone either a total mastectomy or a lumpectomy are eligible; acceptable procedures for assessment of axillary nodal status at the time of surgery include:\r\n* Axillary node dissection;\r\n* Sentinel node biopsy alone; or\r\n* Sentinel node biopsy followed by axillary node dissection