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Clinical Trials in Mexico / NCT01901094
Active, not recruiting Phase 3

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

NCT01901094 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2014-02-24
Last updated
2026-08-31

Condition(s) studied

Stage II Breast CancerStage IIIA Breast Cancer

Investigational drug(s) / intervention(s)

Axillary Lymph Node Dissection (ALND)Nodal Radiation TherapyAxillary Radiation Therapy

Study summary

This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and 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 or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Pre-Registration Eligibility Criteria: * 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 * Patients \>= 18 years of age * 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 or at most 14 days after starting neoadjuvant chemotherapy \* Note: Biopsy of intramammary nodes does not fulfill eligibility criteria * Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry \[IHC\] and/or in situ hybridization \[ISH\]) 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 * Patients must have completed all planned neoadjuvant chemotherapy prior to surgery; sandwich chemotherapy is not allowed (i.e. anthracycline/cytoxan or taxane 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 neoadjuvant chemotherapy (NAC) may be administered at the discretion of the treating medical oncologist * 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 * All patients must have a clinically negative axilla (no 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 * No more than 8 weeks of neoadjuvant endocrine therapy prior to the start of neoadjuvant chemotherapy * No neoadjuvant radiation therapy * No 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 \* 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 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 the last dose of neoadjuvant chemotherapy * A minimum of 1 sentinel node and a maximum of 8 total nodes (sentinel + non-sentinel) are identified and excised; more than 8 nodes identified by either surgeon or pathologist is NOT allowed Note: 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) excised during sentinel lymph node surgery 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 * Note: Patients for whom no positive lymph nodes (sentinel or non-sentinel) are found during sentinel lymph node surgery will not proceed to registration/randomization and can be considered for discussion of the NRG NSABP B-51/RTOG 1304 study "A Randomized Phase III Clinical Trial Evaluating the Role of Post-mastectomy Chest Wall and Regional Nodal XRT and Post-lumpectomy Regional Nodal XRT in Patients with Documented Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy" 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 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) * At least one and no more than 8 lymph nodes (sentinel and non-sentinel) were found by the pathologists to have been actually excised during sentinel lymph node procedure 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

Primary outcome measure(s)

Trial sites (1246)

FacilityCityRegionStatus
Southern Cancer Center PC-Daphne Daphne Alabama
Mobile Infirmary Medical Center Mobile Alabama
Southern Cancer Center PC-Mobile Mobile Alabama
Southern Cancer Center PC-Providence Mobile Alabama
Southern Cancer Center PC-Springhill Mobile Alabama
University of South Alabama Mitchell Cancer Institute Mobile Alabama
Anchorage Associates in Radiation Medicine Anchorage Alaska
Anchorage Radiation Therapy Center Anchorage Alaska
Alaska Breast Care and Surgery LLC Anchorage Alaska
Alaska Oncology and Hematology LLC Anchorage Alaska
Alaska Regional Hospital Anchorage Alaska
Alaska Women's Cancer Care Anchorage Alaska
Anchorage Oncology Centre Anchorage Alaska
Katmai Oncology Group Anchorage Alaska
Providence Alaska Medical Center Anchorage Alaska
Fairbanks Memorial Hospital Fairbanks Alaska
Arizona Breast Cancer Specialists-Gilbert Gilbert Arizona
Virginia G Piper Cancer Care-Glendale Glendale Arizona
Arizona Center for Cancer Care-Peoria Peoria Arizona
Cancer Center at Saint Joseph's Phoenix Arizona
Arizona Breast Cancer Specialists-Phoenix Phoenix Arizona
Arizona Breast Cancer Specialists Scottsdale Arizona
Arizona Breast Cancer Specialists-Scottsdale Scottsdale Arizona
Virginia G Piper Cancer Care-Del Camino Scottsdale Arizona
Arizona Center for Cancer Care-Surprise Surprise Arizona
Banner University Medical Center - Tucson Tucson Arizona
University of Arizona Cancer Center-North Campus Tucson Arizona
Mercy Hospital Fort Smith Fort Smith Arkansas
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
University of Arkansas for Medical Sciences Little Rock Arkansas
Kaiser Permanente-Deer Valley Medical Center Antioch California
PCR Oncology Arroyo Grande California
Sutter Auburn Faith Hospital Auburn California
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
AIS Cancer Center at San Joaquin Community Hospital Bakersfield California
Alta Bates Summit Medical Center-Herrick Campus Berkeley California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
Mills-Peninsula Medical Center Burlingame California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California

+ 1206 more sites — see the full list on the official registry below.

More Alliance for Clinical Trials in Oncology trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01901094 on ClinicalTrials.gov ↗ ← All trials in Mexico