Breast Cancer Clinical Trials

Groundbreaking research has led to new discoveries and improvements in cancer care. Some of the advances are unfolding very rapidly, so it is important you evaluate all of your options.   Clinical trials are research studies that evaluate whether a new drug, treatment, or combination of treatments is safe, effective and possibly better than the current standard-of-care. Clinical trials are the only scientific way to prove whether a new treatment works better than current treatments and the only route to regulatory approval.

For many, including those whose cancer has not responded to standard treatments, a clinical trial may be the best available treatment option.

About 5-10% of breast cancers can be linked to gene mutations (abnormal changes) inherited from one’s mother or father.

BRCA1 and BRCA2 mutations are most common.

Breast Cancer

Breast cancer is a malignant tumor in the breast that can begin in the milk-producing glands (lobules), in the ducts which drain milk from the lobules (ductal carcinoma), and less commonly in the connective tissues of the breast. Invasive lobular carcinoma (ILC), which occurs in about 1 in 10 invasive breast cancers,  can spread (metastasize) to other parts of the body and is considered more challenging to detect via mammogram, and. Ductal carcinoma is either “in situ” (DCIS) or invasive (IDC).  Non-invasive DCIS means that although the cells that have changed to resemble cancer cells, they are localized and havenot spread to other breast tissue.  DCIS occurs in about 1 in 5 new breast cancer cases making it the most common type of breast cancer. Nearly all DCIS cancers can be cured at this stage. Invasive (also called “infiltrating”) ductal carcinoma (IDC), which represents 8 of 10 invasive breast cancers, spreads through the duct wall  into surrounding breast tissue.

ILC or IDC cells can invade nearby healthy tissue and then spread into the underarm lymph nodes, which are located in close proximity, and provide an easy pathway for the cancer to spread into the rest of the body.  The number of lymph nodes with cancer cells indicates the likelihood of cancer in other organs and dictates the treatment path. Breast cancer is staged according to how far the cells have spread in the body from the original site. There are more than 18 recognized subtypes of breast cancer. Learn More from the National Cancer Institute

Some key breast cancer facts and statistics:

  • For women in the U.S., breast cancer death rates are higher than those for any other cancer, besides lung cancer.
  • About 1 in 8 U.S. women (about 12%) will develop invasive breast cancer in her lifetime.
  • Men can get breast cancer- about 2,350 new cases each year. A man’s risk of breast cancer is about 1 in 1,000.
  • About 40,000 women in the U.S. died last year from breast cancer. Breast cancer death rates have been decreasing since 1989, especially in women under 50 due to treatment advances, screening, and educational efforts.
  • Breast cancer risk doubles if a woman has a first-degree relative (mother, sister, daughter) who has had breast cancer. Approximately 15% of women who are diagnosed have a family member who was also diagnosed with breast cancer.
  • About 5-10% of breast cancers can be linked to gene mutations (abnormal changes) inherited from one’s mother or father. BRCA1 and BRCA2 mutations are the most common. BRCA1 mutations result in a 55-65% lifetime risk of developing breast cancer, while for BRCA2 mutations, the risk is 45%. These mutations are more common in younger women and are also associated with an increased ovarian cancer risk.
  • About 85% of breast cancers occur in women who have no family history of breast cancer. These occur due to genetic mutations that happen as a result of the aging process and other unknown factors.

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History of Breast Cancer Research

Unlike other cancers that are more internally located, advanced breast cancer is more visible, which is why it has been recognized as an illness for thousands of years.    There are records (on papyrus) dating back to 1600 BC in which Egyptian scribes wrote about 8 cases of women with breast tumors.  Over the centuries, there were various theories about the root cause of breast cancer—many of them  related to “fluid imbalances.” Other “theories,” up until recently, have included restrictive clothing, physical injury, blockages of the lymph nodes, sexual repression, too much sexual activity, and curdled breast milk. Learn more from the Maurer Foundation

In the mid-1700’s, surgeons started to perform rudimentary procedures in which the breast tissue, underlying muscle, and lymph nodes were removed. These early procedures were the precursor to the radical mastectomy, which was devised by William Halsted in 1882. Halsted’s radical total mastectomy involves removing both breasts, as well as the lymph nodes and underlying muscles, all at the same time. Until the 1950s when  breast-sparing treatments began to be developed, Halsted’s radical mastectomy was the standard of care.

During the 20th century, increasing knowledge about the role of DNA in breast cancer, as well as the understanding that breast cancer was a local as opposed to a  systemic disease, changed the approach to diagnosis. Researchers realized that if breast cancer could be caught earlier,  outcomes would be better.  Drug therapies, including hormone-blocking therapy, chemotherapy, radiation, and monoclonal antibody therapy were developed to be used with or without surgery Learn more from the American Society of Clinical Oncology

Preventative measures such as the drugs Novaldex (tamoxifen and  Evista (raloxifene), as well as prophylactic surgeries, in women with a genetic profile that renders them high risk, have been proven to reduce the risk of breast cancer in this population. Most recently, gene-expression testing, hormonal therapy, less invasive surgery, and changes in diet and lifestyle have become areas of  focus in breast cancer treatment and prevention.

One of the most impactful advances, however, was the realization that early detection could save lives. This evidence-based knowledge is a driver for powerful  advocacy groups that promote education and stress self-examination and having regular mammograms. These efforts have helped reverse the trend in breast cancer mortality rates worldwide.

The role of inherited and non-inherited mutations is better understood and has given rise to tailored therapies.

Current Breast Cancer Research

Genetic testing continues to evolve for breast cancer, with the role of individual mutations versus. multiple mutations being an area of particular concern. In addition to the well-known BRCA 1 and 2 genes, additional breast cancer mutations are being identified, such as thePIK3CA genetic mutation, and researchers are determining how these newly discovered mutations affect cancer progression and treatment.

New prevention studies are underway evaluating various drugs, such as drugs in the retinoid (Vitamin A family) and aromatase inhibitors. Researchers are also attempting to tackle the most advanced forms of breast cancer, which is especially challenging because it can become resistant to commonly used treatments. Recent trials have shown that PARP inhibitors that target BRCA mutations may be successful in patients both with and without BRCA mutations, and in patients who have failed other therapies

Targeted therapies are recognized as being very beneficial for treating many different types and subtypes of cancer, including breast cancer, because they target specific genetic mutations and generally have fewer side effects than traditional chemotherapy. There are many combination therapy approaches that have proven effective, and many others currently being studied in clinical trials. Immunotherapy, a relatively new therapy, is changing the standard of care in many different types of cancer and being developed for various applications. One type of immunotherapy is a vaccine comprised of cancer cells or parts of cancer cell, which can stimulate the body’s immune system to attack and kill cancer cells. Learn more from the Susan G. Komen Foundation

There has been tremendous progress in diagnosing and treating cancer. Long gone are the days when the medical community believed that breast cancer was a systemic disease that developed due to clothing choices or sexual practices. Therapies range from preventative drug and surgical options, to therapeutic minimally invasive surgical techniques and targeted drug therapies. The role of inherited and non-inherited mutations is better understood and has given rise to tailored therapies. Most importantly, women have learned to take charge of their health and now understand that regular self-examinations and mammograms are crucial to catching the disease early, improving outcomes, and decreasing the risk of disease-related mortality.

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Why Cure Forward?

We understand that finding information about specific breast cancer trials or studies related to other forms of cancer can be confusing and difficult.

We hope to make this process easier. When you get started with Cure Forward, your personal Clinical Trial Navigator will help you and your care team build a robust profile inclusive of your full medical history, personal preferences and molecular profile (when applicable), all at no cost. We are able to provide this free service, because we are experienced healthcare experts who focus on building robust profiles for patients, in order to maximize the chance that we can match patients with relevant and active clinical trial options, opening the door to advanced treatments and accelerating medical innovation. We work directly with clinical trial recruiters to help introduce their trials to potential candidates, and we update the trials frequently to help bring current, active studies directly to you.

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