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Breast
General Information
Study Name:
A011202: A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease after Neoadjuvant Chemotherapy
Age Group:
Adult
Protocol Number:
NCT01901094
Background Information:
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.
Offered at:
Inova Alexandria Hospital
4320 Seminary Road
Alexandria, VA 22304
Inova Fair Oaks Hospital
3600 Joseph Siewick Drive
Fairfax, VA 22033
Inova Schar Cancer Institute
3580 Joseph Siewick Drive Suite 403
Fairfax, VA 22033
Inova Medical Group – Breast Surgery
8318 Arlington Boulevard
Suite 305
Fairfax, VA 22031
2296 Opitz Boulevard
Suite 240
Woodbridge, VA 22191
Virginia Surgery Associates, PC
3620 Joseph Siewick Drive
Suite 406
Fairfax, VA 22033
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital
Eligibility Information
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, 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 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 (i.e. equivocal/indeterminate), then patients should not be enrolled.
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. NOTE: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of 6 cycles of neoadjuvant chemotherapy (NAC) is administered. More than 6 cycles of NAC may be administered at the discretion of the treating medical oncologist.
Additional eligibility in protocol
Ineligibility Information
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
Additional ineligibility criteria can be found in protocol.
Contact Information
Contact Name:
Inova Breast Cancer Research Team
Contact Phone:
571-472-0629
Contact Email:
breastcancerresearch@inova.org
Additional Information can be found at
https://clinicaltrials.gov/ct2/show/NCT01901094