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Clinical Trial 18356

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT01901094

Phase: Phase III
Principal Investigator: Diaz, Roberto

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients who have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

Summary

The purpose of this study is to examine whether removing some of the lymph nodes from the arm pit, but not removing them all, followed with radiation therapy (experimental) will be as good as having the majority of the lymph nodes from the arm pit removed during breast surgery followed with radiation (the usual treatment also called standard of care).

Objective

Primary Objective: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy.

Treatments

Therapies

Radiotherapy; Surgery

Medications

Inclusion Criteria

Inclusion Criteria:

PRE-REGISTRATION:

> 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

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.

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.

Have completed all planned chemotherapy prior to surgery. Sandwich chemotherapy is not allowed (i.e., chemotherapy planned to be given after surgery). 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.

Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen). Therapy must be 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.

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.

No more than 8 weeks of neoadjuvant endocrine therapy prior to the start of neoadjuvant chemotherapy.

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.

Not pregnant or nursing. A negative pregnancy test is required for women 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 Criteria apply

Exclusion Criteria

Exclusion Criteria:

Do not meet Inclusion Criteria

INTRA-OPERATIVE REGISTRATION/RANDOMIZATION:

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

A minimum of 1 sentinel node and a maximum of 8 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+). Axillary lymph node dissection [ALND] is not to be performed prior to Registration/Randomization.

POST-OPERATIVE REGISTRATION/RANDOMIZATION:

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 84 days of the completion of neoadjuvant chemotherapy. No additional chemo and no radiation therapy are allowed in the intervening 84 days. Endocrine therapy as a bridge between cytotoxic and surgical treatments are allowed. No experimental agents are allowed during this time. 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). 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.

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