Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer

OBJECTIVES:

- Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node
micrometastases detected by immunohistochemistry in women with stage I or IIA breast
cancer.

- Estimate the prevalence and evaluate the prognostic significance of bone marrow
micrometastases detected by immunocytochemistry in these patients.

- Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are
negative by hematoxylin and eosin (H&E) staining.

- Provide a mechanism for identifying women whose sentinel nodes contain metastases
detected by H&E so that these women can be considered as candidates for ACOSOG-Z0011.

Inclusion Criteria:

1. Patient must be female.

2. Patient's clinical stage must be I or II (T1 or T2 N0 M0) and the tumor must be
amenable to segmental mastectomy (lumpectomy).

3. Patient must have a tissue diagnosis of invasive breast carcinoma. Note: A patient
can be registered to this study if they have a cytologic diagnosis suggestive of
carcinoma from a fine needle aspiration (FNA) of a palpable or non-palpable breast
lesion and the investigator believes the breast lesion is clinically suspicious for
invasive breast carcinoma.

4. The date of the patient's first tissue diagnosis of invasive breast carcinoma or
cytologic diagnosis of breast carcinoma must be no more than 60 days prior to SLND.

5. The patient who had segmental mastectomy (lumpectomy) performed previously, and is
now referred to the local investigator for SLND, is eligible if the lumpectomy was
less than or equal to 60 days prior to the SLND. Copies of the operative and
pathology reports must be submitted as a part of the registration process.

6. Patient must have ECOG/Zubrod status of ≤2, as documented in patient's medical
record.

7. Patient must be available for follow-up.

8. The patient with a history of a previous malignancy is eligible for this study as
long as the patient meets the following criteria for a cancer survivor. A cancer
survivor is eligible provided that the following criteria are met:

1. The patient has undergone potentially curative therapy for all prior
malignancies.

2. There has been no evidence of any prior malignancies for at least five years
with no evidence of recurrence (except for effectively treated basal cell or
squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been
effectively treated by surgery alone, or lobular carcinoma in-situ of the
ipsilateral or contralateral breast treated by surgery alone), and

3. The patient is deemed by their treating physician to be at low risk for
recurrence from prior malignancies.

9. Signed and dated informed consent is obtained prior to patient registration.

10. Patients of childbearing potential must have a negative serum or urine pregnancy test
within 14 days of beginning study interventions.

11. Patient must be able to physically undergo bilateral anterior iliac crest bone marrow
aspiration.

Exclusion Criteria:

1. Patient is lactating (breastfeeding).

2. Patient has been previously treated with chemotherapy, estrogen receptor antagonists
(i.e. Tamoxifen) or selective estrogen receptor modulators (SERMs, i.e. Raloxifene)
for this invasive breast cancer.

3. Patient has a previously placed pre-pectoral breast implant. NOTE: A subpectoral
implant is allowed.

4. Patient is considered a poor surgical risk due to a non-malignant systemic disease
(cardiovascular, renal, etc.), which would preclude the treatment options.

5. Patient has concurrent bilateral invasive breast malignancies.

6. Patient is not able to undergo and does not have access to radiation therapy as
describedin Adjuvant Radiation Therapy in the Interventions section of the protocol.

Patients with active connective tissue disorders and those that live too far from a
radiation treatment center, for example, would not be eligible.

7. Patient has clinically and radiologically identified multi-centric disease that is
not amenable to a single lumpectomy.

8. Patient has had previous ipsilateral axillary surgery such as excisional biopsy of
lymph node(s), treatment of hidradenitis.