Breast Cancer Serum Samples

Bay Biosciences provides high quality, clinical grade fresh frozen (-80°) clinical grade Breast cancer human tumor tissue samples with matched serum (sera), plasma and peripheral blood mononuclear cells (PBMC) biofluid samples from unique Breast cancer patients.

Detailed clinical data and pathology annotations including patient’s corresponding diagnostic test values are provided to a valued pharmaceutical customer for research and drug discovery.

Detailed clinical data including patient’s age, sex, race, corresponding smoking and alcohol use and Estrogen Receptor (ER), Progesterone (PR) and HER2 status, BRCA1 and BRCA2 information associated with tumor tissue samples with matched serum (sera), plasma and PBMC biofluid samples is provided to a valued pharmaceutical customer for research, development and discovery.

Breast Cancer Overview

Cancer begins when healthy cells in the breast change and grow out of control, forming a mass or sheet of cells called a tumor. A tumor can be cancerous or benign. A cancerous tumor is malignant, which means it can grow and spread to other parts of the body. A benign tumor means that the tumor can grow but will not spread to other parts of the body. Breast cancer spreads when the cancer grows into adjacent organs or other parts of the body or when breast cancer cells move to other parts of the body through the blood vessels and/or lymph vessels. This is called a metastasis.

Non-invasive breast cancer (stage 0) is a cancer which is just starting. Early-stage and locally advanced invasive breast cancer, which includes stages I, II, and III. The breast-cancer-stages describes how much the cancer has grown, and if or where it has spread.

Although breast cancer most commonly spreads to nearby lymph nodes, it can also spread further through the body to areas such as the bones, lungs, liver, and brain. This is called metastatic or stage IV breast cancer and is the most advanced type of breast cancer. However, the involvement of lymph nodes alone is generally not IV breast cancer. If breast cancer comes back after initial treatment, it can recur locally, meaning in the same breast and/or regional lymph nodes. It can also recur elsewhere in the body, called a distant recurrence or metastatic recurrence.

Types of Breast Cancer

Breast cancer can be invasive or non-invasive. Invasive breast cancer is a cancer that spreads into surrounding tissues and/or distant organs. Non-invasive breast cancer does not go beyond the milk ducts or lobules in the breast. Most breast cancers start in the ducts or lobes and are called ductal carcinoma or lobular carcinoma:

• Ductal carcinoma. These cancers start in the cells lining the milk ducts and make up the majority of breast cancers.
  • Ductal carcinoma in situ (DCIS). This is a non-invasive cancer that is located only in the duct and has not spread outside the duct.
  • Invasive or infiltrating ductal carcinoma. This is cancer that has spread outside of the duct.
• Invasive lobular carcinoma. This is cancer that started in the lobules and has spread outside of the lobules.

Less common types of breast cancer include:

• Medullary Breast Carcinoma
• Mucinous (Colloid) Breast Cancer
• Tubular Breast Cancer
• Metaplastic Breast Cancer
• Papillary Carcinoma of the Breast
• Inflammatory Breast cancer is an aggressive type of cancer that accounts for about 1% to 5% of all breast cancers.
• Paget’s disease of the Breast is a type of breast cancer that begins in the ducts of the nipple. Although it is usually non-invasive, it can also be an invasive cancer.
  

Breast cancer subtypes

There are three main subtypes of breast cancer that are determined by doing specific tests on a sample of the tumor. These tests will help your doctor learn more about your cancer and recommend the most effective treatment plan.

Testing the tumor sample can find out if the cancer is:

• Hormone Receptor Positive : Breast cancers expressing estrogen receptors (ER) and/or progesterone receptors (PR) are called hormone receptor positive. These receptors are proteins found in cells. Tumors that have estrogen receptors are called ER positive. tumors that have progesterone receptors are called PR positive. Only one of these receptors needs to be positive for a cancer to be called hormone receptor positive. This type of cancer may depend on the hormone estrogen and/or progesterone to grow. Hormone receptor-positive cancers can occur at any age, but are more common in women who have gone through menopause. About two-thirds of breast cancers have estrogen and/or progesterone receptors. Cancer without these receptors are called hormone receptor negative.
• HER2 Positive: About 20% of breast cancers depend on the gene called human epidermal growth factor receptor 2 (HER2) to grow. These cancers are called HER2 positive and have many copies of the HER2 gene or high levels of the HER2 protein. These proteins are also called receptors. The HER2 gene makes the HER2 protein, which is found on the cancer cells and is important for tumor cell growth. HER2-positive breast cancers grow more quickly. They can also be either hormone receptor positive or hormone receptor negative. Cancers that have no or low levels of the HER2 protein and/or few copies of the HER2 gene are called HER2 negative.
• Triple Negative Breast Cancer (TNBC): If a tumor does not express ER, PR, and HER2, the tumor is called triple negative. Triple-negative breast cancer (TNBC) makes up about 15% of invasive breast cancers. Triple-negative breast cancer (TNBC) seems to be more common among younger women, particularly younger Black and Hispanic women. Triple-negative breast cancer (TNBC) is also more common in women with a mutation in the BRCA1 gene. Experts recommend that all people with triple-negative breast cancer (TNBC) younger than 60 be tested for BRCA gene mutations.

Signs and Symptoms of Breast Cancer

The majority of women patients with breast cancer do not have any body changes (signs) or symptoms when they are first diagnosed with breast cancer. Even though patients report symptoms, many times, the cause of a symptom may be a different medical condition that is not cancer. Following are the common signs and symptoms reported by breast cancer patients:

• A lump that feels like a hard knot or a thickening in the breast or under the arm. It is important to feel the same area in the other breast to make sure the change is not a part of healthy breast tissue in that area.
• Change in the size or shape of the breast
• Nipple discharge that occurs suddenly, is bloody, or occurs in only one of the breast
• Physical changes, such as a nipple turned inward or a sore located around the nipple area
• Skin irritation or changes, such as puckering, dimpling, scaling, or new creases on the breast
• A warm, red, swollen breast with or without a rash with dimpling resembling the skin of an orange, called Peau d’Orange.
• Pain in the breast, particularly breast pain that does not go away. Pain is not usually a symptom of breast cancer, but it should be reported to a doctor.

Causes of of Breast Cancer

Breast cancer occurs when some breast cells begin to grow abnormally. These cells divide more rapidly than healthy cells do and continue to accumulate, forming a lump or mass. Cells may spread (metastasize) through the breast to the lymph nodes or to other parts of the body. Breast cancer most often begins with cells in the milk-producing ducts (invasive ductal carcinoma). Breast cancer may also begin in the glandular tissue called lobules (invasive lobular carcinoma) or in other cells or tissue within the breast.

Researchers have identified hormonal, lifestyle and environmental factors that may increase the risk of developing breast cancer. It is not clear why some patients who have no risk factors develop cancer, yet other people with risk factors never do. It’s likely that breast cancer is caused by a complex interaction of the patients genetic makeup and the environment.

Inherited Breast Cancer

It is estimated that about 5 to 10 percent of breast cancers are linked to gene mutations passed through generations of a family. A number of inherited mutated genes that can increase the likelihood of breast cancer have been identified. The most well-known are breast cancer gene1 (BRCA1) and breast cancer gene 2 (BRCA1), both of which significantly increase the risk of both breast and ovarian cancer. If you have a strong family history of breast cancer or other cancers, your doctor may recommend a blood test to help identify specific mutations in BRCA or other genes that are being passed through your family.

Risk factors of of Breast Cancer

A breast cancer risk factor is anything that makes it more likely you’ll get breast cancer. But having one or even several breast cancer risk factors doesn’t necessarily mean you’ll develop breast cancer. Many women patients who develop breast cancer have no known risk factors other than simply being women.

Following are the factors that are associated with an increased risk of breast cancer:

• Being female: Women are much more likely than men are to develop breast cancer.
• Increasing age: Your risk of breast cancer increases as you age.
• A personal history of breast conditions: If you’ve had a breast biopsy that found lobular carcinoma in situ (LCIS) or atypical hyperplasia of the breast, you have an increased risk of breast cancer.
• A personal history of breast cancer: If you’ve had breast cancer in one breast, you have an increased risk of developing cancer in the other breast.
• A family history of breast cancer: If any of your close relatives like your mother, sister or daughter was diagnosed with breast cancer, particularly at a young age, your risk of breast cancer is increased. Still, the majority of patients diagnosed with breast cancer have no family history of the disease.
• Inherited genes that increase cancer risk: Certain gene mutations that increase the risk of breast cancer can be passed from parents to children. The most well-known gene mutations are referred to as BRCA1 and BRCA2. These genes can greatly increase the risk of breast cancer and other cancers, but they don’t make cancer inevitable.
• Radiation exposure: If you received radiation treatments to your chest as a child or young adult, the risk of breast cancer is increased.
• Obesity: Being obese increases the risk of developing breast cancer.
• Starting your period at a younger age: Beginning the period before age 12 increases the risk of developing breast cancer.
• Beginning menopause at an older age: If you began menopause at an older age, you’re more likely to develop breast cancer.
• Having your first child at an older age: Women who give birth to their first child after age 30 may have an increased risk of breast cancer.
• Having never been pregnant: Women who have never been pregnant have a greater risk of breast cancer than do women who have had one or more pregnancies.
• Postmenopausal hormone therapy: Women who take hormone therapy medications that combine estrogen and progesterone to treat the signs and symptoms of menopause have an increased risk of breast cancer. The risk of breast cancer decreases when women stop taking these medications.
• Drinking alcohol: Drinking alcohol increases the risk of breast cancer.

Breast Cancer Diagnosis

For most types of cancer, a biopsy is the only sure way to know if an area of the body has cancer. In a biopsy, the doctor takes a small sample of tissue is taken from the affected area for testing in a laboratory. The series of diagnostic tests needed to evaluate a possible breast cancer usually begins when a woman or their doctor discover a mass or abnormal calcifications on a screening mammogram, or a lump or nodule in the breast during a clinical or self-examination. Less commonly, a patient might notice a red or swollen breast or a mass or nodule under the arm.

Following diagnostic tests may be used to diagnose breast cancer or for follow-up testing after a breast cancer diagnosis:

Breast Cancer Imaging Tests

Imaging tests show pictures of the inside of the body. The following imaging tests of the breast may be done to learn more about a suspicious area found in the breast during screening:

• Diagnostic Mammography: Diagnostic mammography is similar to screening mammography except that more pictures of the breast are taken. It is often used when a patient is experiencing signs, such as a new lump or nipple discharge. Diagnostic mammography may also be used if something suspicious is found on a screening mammogram.
• Ultrasound: An ultrasound uses sound waves to create a picture of the breast tissue. An ultrasound can distinguish between a solid mass, which may be cancer, and a fluid-filled cyst, which is usually not cancer.
• Magnetic resonance imaging (MRI): An MRI uses magnetic fields, not x-rays, to produce detailed images of the body. A special dye called a contrast medium is given before the scan to help create a clear picture of the possible cancer. This dye is injected into the patient’s vein. A breast MRI may be used after a woman has been diagnosed with cancer to find out how much the disease has grown throughout the breast or to check the other breast for cancer. Breast MRI is also a screening option, along with mammography, for some women with a very high risk of developing breast cancer and for some women who have a history of breast cancer. MRI may also be used if locally advanced breast cancer is diagnosed or if chemotherapy or endocrine therapy is being given first, followed by a repeated MRI for surgical planning. MRI may be used as a surveillance method following a breast cancer diagnosis and treatment.

Breast Cancer Biopsy

A biopsy is the removal of a small amount of tissue from the suspected area for examination under a microscope. Other tests can suggest that cancer is present, but only a biopsy can make a definite diagnosis. A pathologist then analyzes the sample(s). There are different types of biopsies, classified by the technique and/or size of needle used to collect the biopsy tissue sample.

• Fine Needle Aspiration (FNA) Biopsy: This type of biopsy uses a thin needle to remove a small sample of cells.
• Core Needle Biopsy: This type of biopsy uses a wider needle to remove a larger sample of tissue. This is usually the preferred biopsy technique for finding out whether an abnormality on a physical examination or an imaging test is invasive cancer and, if so, what the cancer biomarkers are, such as hormone receptor status Estrogen (ER) Progesterone (PR) and HER2 status. Biomarkers, sometimes called tumor markers, are substances in a patients blood, urine, or other body fluids that can also be found in or on the tumor. They are made by the tumor or by the body in response to the cancer. This information helps develop a treatment plan for the breast cancer patient. Local anesthesia, which is medication to block pain, is used to lessen the patient’s discomfort during the procedure.
  
• Surgical Biopsy: This type of biopsy removes the largest amount of tissue. Because surgery is best done after a cancer diagnosis has been made, a surgical biopsy is usually not the recommended way to diagnose breast cancer. Most often, non-surgical core needle biopsies are recommended to diagnose breast cancer in order to limit the amount of tissue removed. Since many people who are recommended to undergo breast biopsy are not diagnosed with cancer, using a needle biopsy for diagnosis reduces the number of people who have surgical procedure unnecessarily.
  
• Image-Guided Biopsy: During this procedure, a needle is guided to the location of the mass or calcifications with the help of an imaging technique, such as mammography, ultrasound, or MRI. A stereotactic biopsy is a type of image-guided biopsy that is done using mammography to help guide the needle. Your doctor will let you know what type of biopsy is best for your situation. A small metal clip is usually put into the breast at the time of biopsy to mark where the biopsy sample was taken, in case the tissue is cancerous and more surgery is needed. This clip is usually titanium so it will not cause problems with future imaging tests.
  
• Sentinel Lymph Node Biopsy: When cancer spreads through the lymphatic system, the lymph node or group of lymph nodes the cancer reaches first is called the sentinel lymph node. In breast cancer, these are usually the lymph nodes under the arms called the axillary lymph nodes. The sentinel lymph node biopsy procedure is a way to find out if there is cancer in the lymph nodes near the breast.

Breast Cancer Biopsy Analysis

Analyzing the biopsy sample(s) removed during the biopsy procedure can help learn about specific features of the cancer that helps determine the treatment options.

• Tumor Features: Examination of the tumor under the microscope is used to determine if it is invasive or non-invasive (in situ); ductal, lobular, or another type of breast cancer, and whether the cancer has spread to the lymph nodes. The margins or edges of the tumor are also examined, and the distance from the tumor to the edge of the tissue that was removed by the biopsy procedure is measured, which is called margin width.
• Estrogen (ER) and Progesterone (PR): Testing for ER and PR  helps determine both the patient’s risk of recurrence (risk of the cancer coming back) and the type of treatment that is most likely to lower the risk of recurrence. Generally, hormonal therapy, also called endocrine therapy, reduces the chance of recurrence of ER-positive and/or PR-positive cancers. Guidelines recommend that the ER and PR status should be tested on the breast tumor and/or areas of spread for everyone newly diagnosed with invasive breast cancer or a breast cancer recurrence. For those with DCIS, testing for ER status is recommended to find out if hormone therapy may reduce the risk of future breast cancer.
• Human Epidermal Growth Factor receptor 2 (HER2): The HER2 status of the cancer helps determine whether drugs that target the HER2 receptor, such as trastuzumab (Herceptin) and pertuzumab (Perjeta), might help treat the cancer. This test is only done on invasive cancers. Guidelines recommend that HER2 testing be done when the patient is first diagnosed with an invasive breast cancer. In addition, if the cancer has spread to another part of the body or comes back after treatment, testing should be done again on the new tumor or areas where the cancer has spread. HER2 tests are usually clearly positive or negative, meaning that your cancer has either a high or low level of HER2. If the test results are not clearly positive or negative, additional testing may need to be done, either on a different tumor sample or with a different test. Sometimes, even with repeated testing, the results may not be conclusive. If the cancer is HER2 positive, HER2-targeted therapy may be a recommended treatment option. If the cancer is HER2 negative, HER2-targeted therapy is not a treatment option, and other treatment options maybe recommended for the breast cancer.
• Tumor Grade: The tumor grade is also determined from a biopsy tissue. Grade refers to how different the cancer cells look from healthy cells, and whether they appear slower growing or faster growing. If the cancer looks similar to healthy tissue and has different cell groupings, it is called well differentiated or a low-grade tumor. If the cancerous tissue looks very different from healthy tissue, it is called poorly differentiated or a high-grade tumor. There are three grades: grade 1 (well differentiated), grade 2 (moderately differentiated), and grade 3 (poorly differentiated).

Breast Cancer Genomic Tests

Genomic Tests for breast cancer to look for specific genes or proteins, which are substances made by the genes, that are found in or on cancer cells. These tests helps better understand the unique features of each patient’s breast cancer. Genomic tests can also help estimate the risk of the cancer coming back after treatment. Knowing this information helps doctors and patients make decisions about specific treatments and can help some patients avoid unwanted side effects from a treatment that may not be needed.

Following genomic tests are done on a biopsy sample of the tumor that was already removed during the biopsy or surgical procedure. Most patients will not need an extra biopsy sample or more surgery for these tests.

• Oncotype Dx Test: This test is an option for people with Estrogen (ER) positive and/or Progesterone (PR) positive, HER2-negative breast cancer that has not spread to the lymph nodes as well as in some cases where the cancer has spread to the lymph nodes. This test can help patients and their doctors make decisions about whether chemotherapy should be added to hormonal therapy. This test looks at 16 cancer-related genes and 5 reference genes to calculate a recurrence score that estimates the risk of the cancer coming back outside of the breast or regional lymph nodes within 10 years after diagnosis, assuming a patient takes 5 years of hormonal therapy. The recurrence score is used to guide recommendations on the use of chemotherapy, which may also differ by age. The recommendations are listed by age group below.

For patients age 50 or younger

• • Recurrence score less than 16: Hormonal therapy is usually recommended, but chemotherapy is generally not needed
  • Recurrence score of 16 to 30: Chemotherapy may be recommended before hormonal therapy is given
  • Recurrence score of 31 or higher: Chemotherapy is usually recommended before hormonal therapy therapy is given

For patients older than 50

• • Recurrence score less than 26: Hormonal therapy is usually recommended, but chemotherapy is generally not needed
  • Recurrence score of 26 to 30: Chemotherapy may be recommended before hormonal therapy is given
  • Recurrence score of 31 or higher: Chemotherapy is usually recommended before hormonal therapy is given
• MammaPrint Test: : This test is an option for people with Estrogen (ER) positive and/or Progesterone (PR) positive, HER2-negative or HER2 positive breast cancer that has not spread to the lymph nodes or has only spread to 1 to 3 lymph nodes. This test uses information from 70 genes to estimate the risk of recurrence for early-stage breast cancer. For people with a high risk of the cancer coming back, this test can help patients and their doctors make decisions about whether chemotherapy should be added to hormonal therapy. This test is not recommended for patients with a low risk of the cancer coming back.
• Molecular Testing of the tumor: Additional tests may be recommend such as running other laboratory tests on a tumor sample to identify specific genes, proteins, and other factors unique to the tumor. If you have locally advanced or metastatic breast cancer, your may be recommend testing for the following molecular features:
  • PD-L1: PD-L1 is found on the surface of cancer cells and some of the body’s immune cells. This protein stops the body’s immune cells from destroying the cancer, especially in triple-negative breast cancer. 
  • Microsatellite instability-high (MSI-H) or DNA mismatch repair deficiency (dMMR): Tumors that have MSI-H or dMMR have difficulty repairing damage to their DNA. This means that they develop many mutations or changes. These changes make abnormal proteins on the tumor cells that make it easier for immune cells to find and attack the tumor.
  • NTRK gene fusions: This is a specific genetic change found in a range of cancer, including breast cancer.
  • PI3KCA gene mutation: This is a specific genetic change commonly found in breast cancer. 
• Additional Tests: There are additional tests that may be options for patients with Estrogen (ER) positive and/or Progesterone (PR) positive, HER2-negative breast cancer that has not spread to the lymph nodes. These tests include Prosigna Breast Cancer Prognostic Gene Signature Assay, EndoPredict test, Breast Cancer Index Test, and  uPA/PAI-1 biomarkers. These tests can be used to estimate how likely the cancer will spread to other parts of the body.

Breast Cancer Blood Tests

Breast cancer patients may also need to do several types of blood tests. Following blood tests tests may be done before or after the surgery:

• Complete Blood Count (CBC): A complete blood count (CBC) test is used to measure the number of different types of cells, such as red blood cells and white blood cells, in a sample of a patients blood. It is done to make sure that the patients bone marrow is functioning well.
• Blood Chemistry: This test evaluates how well the liver and kidneys are working.
• Hepatitis Virus Tests: While not currently the standard of care, these tests are occasionally used to check for evidence of prior exposure to hepatitis B and/or hepatitis C. If you have evidence of an active hepatitis B infection, you may need to take a special medication to suppress the virus before you receive chemotherapy. Without this medication, the chemotherapy can cause the virus to grow and damage the liver.

After diagnostic tests are completed, the doctor will review all of the results. If the diagnosis is cancer, these results also help the doctors describe the cancer, this is called staging. Depending on the stage of the cancer and the tumor biomarkers, additional imaging tests may be recommended. If there is a suspicious area found outside of the breast and nearby lymph nodes, you may need a biopsy of other parts of the body to find out if it is cancer.

Bay Biosciences is a global leader in providing researchers with high quality, clinical grade, fully characterized human tissue samples, bio-specimens and human bio-fluid collections from cancer (tumor) tissue, cancer serum, cancer plasma cancer PBMC and human tissue samples from most other therapeutic areas and diseases.

Bay Biosciences maintains and manages it’s own bio-repository, human tissue bank (biobank) consisting of thousands of diseased samples (specimens) and from normal healthy donors available in all formats and types. Our biobank procures and stores fully consented, deidentified and institutional review boards (IRB) approved human tissue samples and matched controls.

All our human human tissue collections, human specimens and human bio-fluids are provided with detailed samples associated patient’s clinical data. This critical patient’s clinical data includes information relating to their past and current disease, treatment history, lifestyle choices, biomarkers and genetic information. Patient’s data is extremely valuable for researchers and is used to help identify new effective treatments (drug discovery & development) in oncology, other therapeutic areas and diseases. This clinical information is critical to demonstrate their impact, monitor the safety of medicines, testing & diagnostics, and generate new knowledge about the causes of disease and illness. 

Bay Biosciences banks wide variety of human tissue samples and biological samples including cryogenically preserved -80°C, fresh, fresh frozen tissue samples, tumor tissue samples, FFPE’s, tissue slides, with matching human bio-fluids, whole blood and blood derived products such as serum, plasma and PBMC’s.

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