Breast cancer is the second most common cancer among American women. Around 250,000 women and 2,300 men are diagnosed with breast cancer each year in the United States. Each year, breast cancer kills around 42000 women and 510 men in the United States.
With advancements in management options for breast cancer, the survival rate and quality of life of the affected patients have greatly improved. Clinical trials for breast cancer have played a pivotal role in these advancements. Clinical trials are the various research studies that involve people. These trials test the safety and benefits of new treatment modalities and how well new combinations or new dosages of already existing medications work. Clinical trials also explore various other aspects, such as breast cancer prevention, diagnosis, and screening strategies.
You can volunteer to get enrolled in a breast cancer clinical trial. Each trial enrolls people with certain conditions and symptoms. Enrolling in a breast cancer treatment trial will help you receive the treatment before it is widely available to the public. By participating in the trial, you would help develop the knowledge base to improve breast cancer care.
Clinical trials for breast cancer involve three main phases:
- Phase I: This is the initial phase that tests whether the new promising drugs effectively kill cancer cells in laboratory experiments. It tells about the safe dose for the drugs and their benefits in managing cancer. This phase generally enrolls fewer than 50 patients.
- Phase II: This phase starts when the safe dose of a drug has been established in the phase I trial. Phase II explores the potential benefit and side effects of the drug. Fewer than 100 patients are enrolled in this phase.
- Phase III: Phase III begins when the drug or regimen proves promising activity in the phase II trial. This phase involves comparing the new treatment with an existing standard treatment regimen. A comparison may also be done between the new treatment and placebo (such as a sugar pill). Hundreds of thousands of patients may be enrolled in this phase to know whether the new treatment is better than the standard treatment and warrants US FDA approval.
There are various clinical trials presently being conducted for breast cancer. A few of them are:
- Weight loss interventions in treating overweight and obese women with a higher risk for breast cancer recurrence: This is a phase III trial that is dedicated to finding out whether weight loss programs for obese and overweight women diagnosed with breast cancer lowers the risk for breast cancer recurrence.
- Aspirin in preventing the recurrence of cancer in patients with node-positive or high-risk node-negative and HER2-negative breast cancer after chemotherapy, surgery, and/or radiation therapy: This phase III clinical trial is exploring the effect of the drug Aspirin in preventing breast cancer recurrence.
- Doxorubicin hydrochloride and cyclophosphamide followed by Paclitaxel with or without Carboplatin in treating patients with triple-negative breast cancer: This phase III trial is exploring the role of the drugs Doxorubicin hydrochloride and Cyclophosphamide followed by Paclitaxel with or without Carboplatin in treating patients with triple-negative breast cancer.
- Testing the ability to decrease chemotherapy in patients with HER2-positive breast cancer who have no remaining cancer at surgery after limited pre-operative chemotherapy and HER2-targeted therapy: This trial explores the effect of the drugs paclitaxel, trastuzumab, and pertuzumab in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer, who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after preoperative chemotherapy and HER2-targeted therapy.
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Breast cancer is an invasive tumor that develops in the mammary gland. Breast cancer is detected via mammograms, breast self-examination (BSE), biopsy, and specialized testing on breast cancer tissue. Treatment of breast cancer may involve surgery, radiation, hormone therapy, chemotherapy, and targeted therapy. Breast cancer risk may be lowered by managing controllable risk factors.
What you should know about breast cancer
- Breast cancer is the most common cancer among American women.
- One in every eight women in the United States develops breast cancer.
- There are many types of breast cancer that differ in their capability of spreading (metastasize) to other body tissues.
- The causes of breast cancer are unknown, although medical professionals have identified a number of risk factors.
- There are many different types of breast cancer.
- Breast cancer symptoms and signs include
- a lump in the breast or armpit,
- bloody nipple discharge,
- inverted nipple,
- orange-peel texture or dimpling of the breast's skin (peau d'orange),
- breast pain or sore nipple,
- swollen lymph nodes in the neck or armpit, and
- a change in the size or shape of the breast or nipple.
- Breast cancer can also be symptom free, which makes following national screening recommendations an important practice.
- Breast cancer is diagnosed during a physical exam, by a self-exam of the breasts, mammography, ultrasound testing, and biopsy.
- Treatment of breast cancer depends on the type of cancer and its stage (0-IV) and may involve surgery, radiation, or chemotherapy.
Breast Cancer and Coping With StressBeing diagnosed with breast cancer is stressful. Learning relaxation techniques, exercising, eating well, getting adequate sleep, receiving psychotherapy, and maintaining a positive attitude can help you cope. Creating documents, such as an advance directive, living will, and durable power of attorney will outline your wishes in the event that you are no longer able to make decisions regarding your care.
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Clinical TrialsClinical trials are a form of clinical research that follow a defined protocol that has been carefully developed to evaluate a clinical question. Clinical research is a type of study of clinical or biomedical questions through the use of human subjects. Clinical trials are divided into five types: treatment trials, prevention trials, diagnostic trials, screening trials, and quality of life trial.
Enhertu (fam-trastuzumab deruxtecan-nxki)Enhertu is a prescription medicine used in adults to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of your body (metastatic), and who have received two or more prior anti-HER2 breast cancer treatments. Serious side effects of Enhertu include interstitial lung Disease (ILD) and pneumonitis including fatal cases), and embryo-fetal toxicity.
Faslodex (fulvestrant) InjectionFaslodex (fulvestrant) is a prescription medicine used to treat advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic). Serious side effects of Faslodex include injection site-related nerve damage. The most common side effects of Faslodex include injection site pain, nausea, muscle, joint, and bone pain; headache, back pain, tiredness, pain in arms, hands, legs, or feet; hot flashes, vomiting, and others.
Margenza (margetuximab-cmkb)Margenza (margetuximab-cmkb) is a HER2/neureceptor antagonist indicated, in combination with chemotherapy, to treat adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
What Is the Difference Between a Radical Mastectomy and Modified Radical Mastectomy?In a radical mastectomy, the entire breast tissue along with the nipple, covering skin, lymph nodes (filter organs for harmful substances) in the armpit and chest wall muscle under the breast is removed. It is known as a standard treatment for breast cancer. In a modified radical mastectomy (MRM), the entire breast is removed, including the skin, areola (surrounding the nipple), nipple and most armpit lymph nodes. The underlying chest wall muscles (the pecs) will be left intact. Additionally, the skin covering the chest wall may or may not be removed.
What Are the Risk Factors for Developing Breast Cancer?Breast cancer refers to the uncontrolled growth of cells within the breast. The risk factors for developing breast cancer include age, genetics, family history, personal history, menstrual history, breast density, previous radiation therapy, ethnicity, body weight, physical activity level, reproductive history, alcohol consumption and hormone pill use.
What Age Should a Woman Get a Mammogram?Regular mammography (X-ray breast imaging) helps in detecting breast cancer early, sometimes up to three years before a breast lump is noticeable in self-exam. Women should start getting a mammogram every year at age 45, assuming they have no risk factors that would require earlier screening, but may dial back to every couple years after 55 when the peak statistical risk of breast cancer has passed.