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Information ⬇

Synonym/Acronym

N/A

Rationale

To assist in establishing a diagnosis of breast disease; in the presence of breast cancer, this test is also used to assist in evaluating prognosis and management of response to therapy.

Patient Preparation

There are no activity restrictions unless by medical direction. Instruct the patient that to reduce the risk of aspiration related to nausea and vomiting, solid food and milk or milk products are restricted for at least 6 hr, and clear liquids are restricted for at least 2 hr prior to general anesthesia, regional anesthesia, or sedation/analgesia (monitored anesthesia). The patient may be required to be NPO after midnight. The American Society of Anesthesiologists has fasting guidelines for risk levels according to patient status. More information can be located at https://pubs.asahq.org/anesthesiology/article/126/3/376/19733/.

Regarding the patient’s risk for bleeding, the patient should be instructed to avoid taking natural products and medications with known anticoagulant, antiplatelet, or thrombolytic properties or to reduce dosage, as ordered, prior to the procedure. Number of days to withhold medication is dependent on the type of anticoagulant. Note the last time and dose of medication taken. Protocols may vary among facilities.

Patients on beta blockers before the surgical procedure should be instructed to take their medication as ordered during the perioperative period.

Normal Findings

(Method: Macroscopic and microscopic examination of tissue for biopsy; cytochemical or immunohistochemical for estrogen and progesterone receptors Ki67, PCNA, TP53; flow cytometry for DNA ploidy and S-phase fraction; immunohistochemical or FISH for Her-2/neu) Fluorescence in situ hybridization (FISH) is a cytogenic technique that uses fluorescent-labeled DNA probes to detect specific chromosome abnormalities. Favorable findings:

  • Biopsy: No abnormal cells or tissue.
  • DNA ploidy: Majority diploid cell population.
  • SPF: Low fraction of replicating cells in total cell population.
  • Her-2/neu, Ki67, PCNA, and TP53: Negative to low percentage of stained cells.
  • Estrogen and progesterone receptors: High percentage of stained cells.

Critical Findings and Potential Interventions ⬆ ⬇

Timely notification to the requesting health-care provider (HCP) of any critical findings and related symptoms is a role expectation of the professional nurse. A listing of these findings varies among facilities.

Overview ⬆ ⬇

(Study type: Tissue and cell microscopy, breast tissue or cells; related body system: Immune and reproductive systems.) Label the appropriate specimen containers with the corresponding patient demographics, initials of the person collecting the specimen, date and time of collection, and site location, especially right or left breast.

Breast cancer is the most common newly diagnosed cancer in American women. It is the second leading cause of cancer-related death.

Biopsy (Bx) is the excision of a sample of tissue that can be analyzed microscopically to determine cell morphology and the presence of tissue abnormalities. Fine-needle and open biopsies of the breast have become more commonly ordered in recent years as increasing emphasis on early detection of breast cancer has become stronger. Breast biopsies are used to assist in the identification and prognosis of breast cancer. A number of tests can be performed on breast tissue to assist in identification and management of breast cancer.

Liquid biopsy is a rapidly developing area of research for the diagnosis and management of cancers to include breast and prostate. Blood samples are collected by venipuncture, a process that is less invasive than tissue biopsy. The liquid biopsy samples are evaluated either for known biomarkers of cell tumor DNA (ctDNA) or for intact circulating tumor cells (CTC) shed by the tumor into the bloodstream. For additional information regarding blood-based markers associated with breast cancer, refer to the study titled “Cancer Markers.”

Estrogen and progesterone receptor assays (ER and PR) are used to identify patients with a type of breast cancer that may be more responsive than other types of tumors to estrogen-deprivation (antiestrogen) therapy or removal of the ovaries. Patients with these types of tumors generally have a better prognosis.

DNA ploidy testing by flow cytometry may also be performed on suspicious tissue. Cancer is the unchecked proliferation of tumor cells that contain abnormal amounts of DNA. The higher the grade of tumor cells, the more likely abnormal DNA will be detected. The ploidy (number of chromosome sets in the nucleus) is an indication of the speed of cell replication and tumor growth. Cells synthesize DNA in the S phase of mitosis. S-phase fraction (SPF) is an indicator of the number of cells undergoing replication. Normal tissue has a higher percentage of resting diploid cells, or cells containing two chromosomes.

Aneuploid cells contain multiple chromosomes. Genes on the chromosomes are coded to produce specific proteins. Ki67 and proliferating cell nuclear antigen (PCNA) are examples of proteins that can be measured to indicate the degree of cell proliferation in biopsied tissue. Overexpression of a protein called human epidermal growth factor receptor 2 (HER-2/neu oncoprotein) is helpful in establishing histological evidence of metastatic breast cancer. Patients with metastatic breast cancer with high levels of HER-2/neu oncoprotein have a poor prognosis. They have rapid tumor progression, increased rate of recurrence, poor response to standard therapies, and a lower survival rate. Herceptin (trastuzumab) has been the treatment of choice for treatment of HER-2/neu overexpression; in 2022 a new drug, Enhertu, was approved by the U.S. Food and Drug Administration (FDA). Similar to Herceptin, Enhertu targets cells for treatment of HER-2/neu overexpression but it is also able to selectively act on tumor cells as it is released by IV administration into the patient’s bloodstream.

TP53 (tumor protein 53, also known as p53) is a suppressor protein that normally prevents cells with abnormal DNA from multiplying. Sequence variations in the TP53 gene cause the loss of TP53 functionality; the checkpoint is lost, and cancerous cells are allowed to proliferate.

Knowledge of genetics assists in identifying those who may benefit from additional education, risk assessment, and counseling. Genetics is the study and identification of genes, genetic sequence variations, and inheritance. For example, genetics provides some insight into the likelihood of inheriting a condition associated with a type of cancer such as breast cancer. Genomic studies evaluate the interaction of groups of genes. The combined activity or combined expression of groups of genes allows assumptions or predictions to be made. As an example, genomic studies measure the levels of activity in multiple genes to predict how they influence the development and growth of a tumor. Further information regarding inheritance of genes can be found in the study titled “Genetic Testing.” There are a number of genomic tests developed for breast cancer. The four FDA-approved tests included in this discussion are Oncotype DX breast cancer recurrence score, Oncotype DX Ductal carcinoma in situ (DCIS), MammaPrint, and Prosigna.

Fluid from breast cysts or nipple discharge may be collected by aspiration and examined microscopically for benign or cancerous findings. Mammography should be performed before aspiration of cyst fluid because of the potential interference to the mammogram from bleeding. Potential complications of fluid aspiration include infection, pneumothorax, and hematoma.

Sentinel lymph node biopsy (SLNB) may be considered to assist in the diagnosis of breast cancer. A sentinel lymph node (SLN) is the first lymph node to be infiltrated by cancer cells from the primary tumor, usually in the axilla or armpit area. To identify an SLN, the surgeon injects one or more tracers (such as technetium-99m and isosulfan blue dye) near the tumor, then uses a handheld gamma detector to locate the nodes emitting radioactivity or visually inspects the nearby nodes for any that are stained blue from the dye. Once the SLN is located, a small incision is made and the node is removed. The suspicious tissue is checked microscopically for the presence of cancer cells by a pathologist. Positive SLN samples may warrant immediate removal of additional lymph nodes or removal during a follow-up procedure. SLNB is used to assist in staging cancers, to estimate the risk of metastasis to other parts of the body, and in the case of negative SLN testing to avoid the unnecessary removal of nearby lymph nodes. Adverse effects of lymph node surgery include lymphedema, pain, and increased risk of infection in the affected area.

There are a number of risk factor tools that can be used to estimate an individuals’s risk of breast cancer. The tools cannot determine whether a person will get breast cancer. The tools are based on the average risk for a group of women with similar risk factors; the original tools were based on data from women of European ethnicity. Generally, an HCP will consider the number of risk factors a person has and how much each factor contributes to increasing the risk for breast cancer (e.g., a BRCA1 gene sequence variation contributes a significant amount of risk). The Gail model, commonly used by HCPs, calculates women’s short-term risk (within the next 5 yr) and long-term risk (within their lifetime, up to age 90 yr) of developing breast cancer. It is based on seven key risk factors.

  1. Current age
  2. Age at first menstrual period
  3. Age at the first birth of a child (or a person who has not given birth)
  4. Family history of breast cancer (mother, sister, daughter)
  5. Number of past breast biopsies
  6. Number of breast biopsies showing atypical hyperplasia
  7. Ethnicity
Women with a 5-yr risk of 1.67% or greater are classified as high risk, which is the FDA’s guideline for taking a drug such as tamoxifen or raloxifene to reduce the risk of developing breast cancer. Other commonly used tools include the Claus model and the Tyrer-Cuzick model.

Indications ⬆ ⬇

Contraindications ⬆ ⬇

Patients with bleeding disorders (related to the potential for prolonged bleeding from the biopsy site).

Interfering Factors ⬆ ⬇

Potential Medical Diagnosis: Clinical Significance of Results ⬆ ⬇

Positive Findings in

  • Cancer
  • Hormonal therapy (ER and PR)
  • Receptor-positive tumors (ER and PR)

Nursing Implications ⬆

Before the Study: Planning and Implementation

Teaching the Patient What to Expect

  • Review the procedure with the patient.
  • Discuss how this procedure can assist in evaluating breast health. Biopsy is performed under sterile conditions. Open biopsy takes about 20 to 30 min. Needle biopsy takes about 15 min. Sutures may be necessary to close the site.
  • Explain that prior to the procedure, laboratory testing may be required to determine the possibility of bleeding risk (coagulation testing) or to assess for impaired kidney function (creatinine level and estimated glomerular filtration rate) if use of iodinated contrast medium is anticipated. Pregnancy testing may be required.
  • Explain that the area of interest is marked with a surgical marking pen prior to the procedure. Address cultural issues regarding modesty.
  • Explain that reducing health-care-associated infections is an important patient safety goal, and a number of different safety practices will be implemented during their procedure. Hair near the incision site may be clipped or shaved and cleaned with an antiseptic solution to remove bacteria from the skin and reduce infection risk.
  • Discuss how there may be moments of discomfort or pain when the IV line or catheter is inserted allowing for infusion of fluids such as saline, anesthetics, sedatives, medications used in the procedure, or emergency medications. Prophylactic antibiotics may be administered before the procedure.

Procedural Information

  • Note: The World Health Organization, Centers for Disease Control and Prevention, and Association of periOperative Registered Nurses recommend that hair not be removed at all unless it interferes with the incision site or other aspects of the procedure because hair removal by any means is associated with increased infection rates.
  • Hair removal requires facilities to use a protocol that is based on scientific literature or the endorsement of a professional organization. Clipping immediately before the procedure and in a location outside the procedure area is preferred to shaving with a razor. Shaving creates a break in skin integrity and provides a way for bacteria on the skin to enter the incision site.
  • Baseline vital signs are monitored throughout the procedure. Continuous monitoring is performed to assess for complications related to the procedure (e.g., allergic reaction).
  • Positioning is in the supine position. The area of interest is marked with a surgical marking pen prior to the procedure, and the biopsy is performed under sterile conditions.
  • Protocols may vary among facilities.

Needle Biopsy

  • The site is protected with sterile drapes.
  • The patient is directed to take a deep breath, exhale forcefully, and hold their breath while the biopsy needle is inserted and rotated to obtain a core of breast tissue and not to breathe until the needle is removed.
  • After the needle is removed, pressure is applied to the site for 3 to 5 min and then a pressure dressing is applied over the incision site.
  • The specimens are labeled indicating site location and laterality, and promptly transported to the laboratory for processing and analysis.

Open Biopsy

  • Adherence to organizational policies and the Centers for Medicare and Medicaid Services (CMS) quality measures is required regarding administration of ordered prophylactic antibiotics given 1 hr before the incision. Antibiotics used are consistent with current guidelines specific to the procedure.
  • After administration of general anesthetic and surgical preparation are completed, an incision is made, suspicious area(s) are located, and tissue samples are collected and placed in formalin solution.
  • The specimens are labeled indicating site location and laterality, and promptly transported to the laboratory for processing and analysis.

Potential Nursing Actions

Make sure a written and informed consent has been signed prior to the procedure and before administering any medications.

Safety Considerations

  • Anticoagulants, aspirin, and other salicylates should be discontinued by medical direction for the appropriate number of days prior to a procedure in which bleeding is a potential complication.
  • Ensure the patient is able to follow directions and lie still for the procedure.

After the Study: Implementation & Evaluation Potential Nursing Actions

Avoiding Complications

  • Monitor the patient for complications related to the procedure.
  • Establishing an IV site and tissue biopsy are invasive procedures that can cause rare complications. For additional information see Appendix A: Patient Preparation Specimen Collection, subsection: Potential Contraindications and Complications Associated With Diagnostic Procedures.
  • Instruct in the care and assessment of the biopsy site.
  • Observe/assess the biopsy site for bleeding, inflammation, or hematoma formation; advise reporting any fever, chills, redness, edema, bleeding, or pain at the biopsy site.
  • Bleeding (related to a bleeding disorder or the effects of natural products and medications with known anticoagulant, antiplatelet, or thrombolytic properties) or seeding of the biopsy tract with tumor cells are potential complications associated with breast biopsy.

Treatment Considerations

  • Follow postprocedure vital sign and assessment protocol.
  • Administer ordered antibiotic therapy and emphasize the importance of completing the entire antibiotic course. Discontinue prophylactic antibiotics within 24 hr after the conclusion of the procedure. Protocols may vary among facilities.
  • Assess for nausea and pain with administration of ordered antiemetic and analgesic medications.
  • Review breast cancer pathophysiology including ongoing treatment, screenings, and medical vs surgical options. Advise that a health-care specialist consult may be needed to manage the disease and therapeutic interventions.
  • Discuss the value of attending cancer support group meetings to help adjust to body changes and address intimacy concerns.

Safety Considerations

  • Assess the ability to swallow before allowing the patient to drink liquids or eat solid foods to decrease aspiration risk.
  • Instruct the patient to resume preoperative diet, as directed by the HCP.

Clinical Judgement

  • Consider how vulnerable it feels to have no control over a disease that may change the trajectory of your life. Then consider what you can do to mitigate that.

Follow-Up Evaluation and Desired Outcomes

  • Understands that decisions regarding the need for and frequency of breast self-examination, mammography, magnetic resonance imaging or ultrasound of the breast, or other cancer screening procedures should be made after consultation between the patient and HCP.
  • Acknowledges that the most current guidelines for breast cancer screening of the general population as well as of individuals with increased risk are available from the American Cancer Society (www.cancer.org), the American College of Obstetricians and Gynecologists (www.acog.org), and the American College of Radiology (www.acr.org). Screening guidelines vary depending on the age and health history of those at average risk and those at high risk for breast cancer. The ASCO recommends that regular physical examinations and mammography be used to identify recurrence of breast cancer. Guidelines may not always agree among organizations; therefore, it is important for patients to participate in their health care, be informed, ask questions, and follow their HCP’s recommendations regarding frequency and type of screening. For additional information regarding screening guidelines, refer to the study titled “Mammography.”
  • Demonstrates correct care of the surgical site. Agrees to a follow-up appointment for removal of sutures, if indicated.
  • Agrees to adhere to the therapeutic regimen, including self-administration of medication. Understands information about adverse effects and the option to review corresponding literature provided by a pharmacist.