Breast Cancer Clinical Trials

Research is discovering and making improvements for care in some cancers 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.  They are the only scientific way to prove whether a new treatment works better than current treatments.

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, and less commonly in the connective tissues of the breast. Invasive lobular carcinoma (ILC) can spread (metastasize) to other parts of the body, can be more challenging to detect via miammogram, and occurs in about 1 in 10 invasive breast cancers. Ductal carcinoma is either “in situ” (DCIS) or invasive (IDC).  Non-invasive DCIS is due to cells that have changed to resemble cancer cells but have not invaded into other breast tissue.  DCIS occurs in about 1 in 5 new breast cancer cases making it the most common type of breast cancer, and nearly all can be cured at this stage. Invasive (also called “infiltrating”) ductal carcinoma (IDC) invades through the duct wall and into the tissue of the breast, and 8 of 10 invasive breast cancers are of this type. Learn More from the National Cancer Institute

ILC or IDC cells can invade nearby healthy tissue and then into the underarm lymph nodes, which are located in close proximity, and provide an easy pathway 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 origin and 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 and 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 education efforts.
  • Breast cancer risk doubles if a woman has a first-degree relative (mother, sister, daughter) who has had breast cancer. Approximately 15% of cases had a diagnosed family member.
  • About 5-10% of breast cancers can be linked to gene mutations (abnormal changes) inherited from one’s mother or father. BRCA1 and BRCA2 mutationsare most common. BRCA1 mutations result in a 55-65% lifetime risk of developing breast cancer, and for BRCA2 mutations, the risk is 45%. These mutations are more common in younger women and are 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

Breast cancer, unlike other cancers that are more internally located, is more visible when advanced and therefore caught attention over the ages.  It can be traced back to ancient Egypt in 1600 BC where 8 cases of breast tumors were written about on papyrus.  Over the centuries, theories of cause were generally related to “fluid imbalances.” Other theories, up until recently, 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

The mid-1700’s saw the onset of localized breast surgery and surgeons performing early procedures removing breast tissue, underlying muscle and lymph nodes, which became the precursors to the radical mastectomy, which was devised by William Halsted in 1882. Halsted’s development of  the radical total mastectomy, which removed both breasts, lymph nodes and underlying muscles all together, was the treatment standard until breast-sparing treatments began to be developed in the 1950s. The 20th century brought the discovery of the role of DNA in breast cancer and the knowledge that breast cancer was a local vs. systemic disease, and therefore could be controlled if caught early. Drug therapies, including hormone blocking therapy, chemotherapy, and monoclonal antibody therapy were developed to be used with surgery or without, in addition to radiation. Learn more from the American Society of Clinical Oncology

Preventative measures such as the drugs tamoxifen (Novaldex) and raloxifene (Evista), as well as propholactic surgeries, have been proven to reduce the risk of breast cancer in women at high risk. Gene expression testing, hormonal therapy, less-invasive surgery, and changes in diet and lifestyle became the most recent focus in breast cancer treatment and prevention. However, one of the most impactful advances was the realization that early detection could save lives, which gave rise to the powerful and active advocacy groups that promote education and stress self-examination and the importance of having regular mammograms, which helped reverse the trend in death rates for breast cancer 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 develop for breast cancer, and the role of individual mutations vs. multiple mutations is being further explored.  Additional breast cancer mutations are being identified, such as a mutation in the PIK3CA gene, and researchers are determining how these newly discovered mutations affect cancer progression and treatment.  New preventative treatments are under study, such drugs in the retinoid (Vitamin A family) and aromatase inhbitors.  Advanced cancer is very challenging as it can become resistant, and recently trials have shown that PARP inhibitors that target BRCA mutations may be successful in patients both with and without BRCA mutations.  Targeted therapies have been recognized across many cancers as being very beneficial, as they target specific genetic changes with a reduction in side effects, and several are currently on the market with others in clinical trials. Combination therapies continue to be explored, and there are current trials of both approved and experimental combination therapies.  Immunotherapy is another newer therapy being researched, that has garnered a lot of interest.  One type is a vaccine that is comprised of cancer cells or parts, that can stimulates the body’s immune system to attack and kill cancer cells.  Learn more from the Susan G. Komen Foundation

Breast cancer has seen tremendous progress – long gone are the days believing that it was a systemic disease, disease due to clothing choices or sexual practices.  Therapies range from preventative drug and surgical options, to therapeutic minimally invasive surgical techinques 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 that regular self-examinations and mammograms are crucial to catching the disease early and improving mortality rates.

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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.  Through our Clinical Trial Exchange, Cure Forward collects data on clinical trials and studies from multiple sources making it easier to find all the options that are available for you or your loved one.  We work directly with clinical trial recruiters to help introduce their trials to potential candidates.  We update the trials frequently to help bring current, active studies directly to you.

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