Tag Archive for: Breast Cancer Awareness

Triple-Negative Breast Cancer: Sharon’s Clinical Trial Profile

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Breast cancer patient Sharon was diagnosed with triple-negative invasive lobular carcinoma after she found a lump after working out. Watch as she shares her breast cancer journey through two stages along with treatment – and what she learned and experienced with clinical trials and her advice to other patients. In Sharon’s words, “I do think that patients should be given all of their options upfront. I don’t think that clinical trials should be the last resort.”

Immunotherapy vs. Breast Cancer

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Immunotherapy vs. Breast Cancer.  In a landmark study, a patient’s advanced breast cancer regressed completely after treatment with immune cells that recognized products of mutations specific to her cancer.

Immunotherapy vs. Breast Cancer

At the top of the image are cells isolated from a patient’s tumor directly after it was removed by surgery. The sample includes a combination of dark tumor cells, tumor-infiltrating lymphocytes (TILs) and other inflammatory cells. Below, the same culture is shown after two to three weeks of growth. This is a pure sample of TILs and is used to select lymphocytes that are able to identify the products of mutations unique to the patient’s tumor. Once multiplied, TILs are then infused into the patient. Credit: James Yang, CCR, NCI, NIH.

In an ongoing NCI-led clinical trial at the NIH Clinical Center, a patient with metastatic breast cancer has experienced complete regression of her disease after treatment with an experimental immunotherapy developed in CCR. Despite multiple prior cancer treatments, her cancer continued to enlarge and spread until she received this new treatment. The case report, published in Nature Medicine, highlights the potential of immunotherapy for difficult-to-treat solid tumors.

Although cancer immunotherapies have brought about complete regression of disease in some patients, certain types of cancer, including breast cancer, have been difficult to treat with these approaches. The experimental approach being tested in the current trial, developed by CCR Surgery Branch Chief Steven A. Rosenberg, M.D., Ph.D., and colleagues, uses immune cells selected for their ability to recognize cells with mutations specific to a patient’s tumor to fight their disease—a strategy that Rosenberg says may serve as a blueprint to treat many cancers.

This type of immunotherapy, called adoptive cell transfer (ACT), uses cancer-fighting cells from a patient’s own immune system that are grown in large numbers in the laboratory and then infused into the patient. The specific form of ACT being investigated uses immune cells that have been isolated directly from a patient’s tumor, known as tumor-infiltrating lymphocytes (TILs). The key to this approach is the identification and use of only TILs that specifically recognize proteins encoded by genetic mutations present in the patient’s cancer.

Steven A. Rosenberg, M.D., Ph.D.

Steven A. Rosenberg, M.D., Ph.D.

The TILs used to successfully treat this patient’s breast cancer were selected after researchers compared the DNA and RNA from one of her tumors to her normal tissue and identified 62 mutations unique to her cancer. Next, the TILs isolated from her tumor were tested for their ability to recognize the products of these mutations. TILs recognizing proteins encoded by four different cancer-specific mutations were then selected for treatment. Along with the tumor-specific immune cells, the patient was given pembrolizumab, an immune system checkpoint inhibitor that allows cancer-fighting cells to remain active in the microenvironment of a tumor, and interleukin-2, which promotes immune cell growth.

More than three years after the treatment, the patient’s breast cancer has not returned. The team has also seen this type of immunotherapy trigger tumor regression in patients with liver cancer, colorectal cancer and cervical cancer, offering hope that it might be a broadly effective treatment strategy.

Selected References

Zacharakis N, et al. Nat Med. 2018 Jun;24(6):724-730.

FDA Urges Inclusion of Men in Breast Cancer Clinical Trials

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From Forbes
August 28, 2019
by Victoria Forster

FCA Recommends that men be included in breast cancer clinical trials. Men with breast cancer make up less than one percent of all breast cancer cases, but they are more likely than women to be diagnosed at a later stage of disease and at an older age, which can make treating the cancer more challenging. However, because the disease is relatively rare in men, they are often excluded from clinical trials to explore new treatments. Now a new document released by the FDA is urging companies to change this and include men in their trials.

“Today we issued a draft guidance encouraging the inclusion of male patients in breast cancer clinical trials,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “When finalized, the recommendations in the draft guidance will provide clarity for industry regarding how additional data to support efficacy and safety for male patients with breast cancer can be generated through a variety of trial designs using different data sources, including studies using real-world data,” he added.

Similarly to women with the disease, the survival rates for men vary depending on a number of factors, such as how early the tumor is diagnosed and whether it has spread from the breast to another site in the body.  But because of a lack of trials involving men, there are fewer approved therapies and men can more quickly run out of options if their cancer stops responding to the limited number of approved drugs.

“I couldn’t find a breast cancer trial in Australia, and there were very few in the US that that guys I know with this disease could participate in,” said Rod Ritchie, a 68 year-old patient advocate for men with breast cancer and a National Breast Cancer Coalition Project LEAD graduate, designed to help train breast cancer advocates. “I eventually recently joined an online study on the use of Tamoxifen which was based in the US and which accepted all nationalities and genders,” he added.

Tamoxifen, which has been credited with significantly improving the outcomes of women with hormone positive (HR+) breast cancer is often especially useful for men, 90 percent of which have HR+ breast cancer according to the American Cancer Society. Tamoxifen is reasonably well studied in men, but for those with hormone receptor negative breast cancer, or who do not respond or stop responding to tamoxifen, there are no other hormone targeting drugs which have been extensively studied in men.

The FDA document is aimed at industry and does not include any set rules for including men in breast cancer trials, so it will have to be seen whether companies developing new treatments take note of the new guidelines and open up their trials to men.

“We hope that the recommendations in the draft guidance issued today will, when finalized, encourage drug development for the treatment of male breast cancer and ultimately, provide additional FDA-approved treatment options for patients,” said Pazdur.

“We need awareness campaigns, especially for those of us with BRCA genes, and we need to de-gender all references to breast cancer. Later diagnoses to leading to poorer prognoses. We’re dying for a change,” said Ritchie.