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.”

TMIST Ramps Up to Illuminate Breast Cancer Screening

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TMIST (Tomosynthesis Mammographic Imaging Screening Trial), the large NCI screening study to learn about the best ways to find breast cancer in women who have no symptoms, is ramping up with 16,505 participants enrolled to date at 84 certified mammography clinics in the United States, Canada and Argentina.

Photo of Etta Pisano

Etta Pisano, MD, chief research officer at the American College of Radiology, and the principal investigator of TMIST

The number of women and sites participating is likely to increase rapidly in the months ahead. Etta Pisano, MD, chief research officer at the American College of Radiology, and the principal investigator of TMIST, heads the efforts to get clinics involved.  “We have 15 approved clinics working on the logistics to begin enrollment, and another 34 have committed to joining. We are pleased that there has been a great deal of interest from international sites and expect to bring on additional sites in Europe and Asia in the next 6 months,” Dr. Pisano said.

TMIST is a randomized phase 3 trial comparing standard digital mammography (2-D) with the newer tomosynthesis mammography (3-D). The goal is to follow all participants to see if they are diagnosed with breast cancer or a precancerous condition, and to record their treatment and outcomes from the time of randomization until the end of the study.

TMIST was designed to provide evidence about the role of mammography screening in reducing the incidence of life threatening, advanced breast cancers. This is a stand-in for breast cancer mortality, the usual endpoint for screening trials, because a trial using that endpoint would take many more years to complete.

All told, 164,946 healthy women ages 45 to 74 who are already planning to get routine mammograms will be enrolled. Women will be randomized to either 3-D or 2-D screening mammograms for 5 years. Each woman is assigned to a screening frequency of every 1 or every 2 years, based on her individual risks for developing breast cancer.

While Medicare and many private insurance programs provide full cost coverage for screening mammograms, with no co-pay, copays are still allowed for some mammograms in some states.  Based on requests from women taking part in TMIST, some states are now funding co-payments or completely covering the participants’ cost for mammograms, according to the American College of Radiology (ACR).  The study also has some funding for uninsured patients subject to the charity care policies of the participating institutions.

States with Laws that Mandate
NO Co-pay for Screening Mammograms		 States with Laws that Allow
Co-pays for Screening Mammograms
Arizona, Colorado, Connecticut, Illinois, Kansas, New Hampshire, New Jersey, New York, Oklahoma, Pennsylvania, Texas, Vermont, Washington Kentucky, Louisiana, Maryland, Montana

TMIST is supported by the NCI Community Oncology Research Program (NCORP) and co-led by the ECOG-ACRIN Cancer Research Group. “About 50 million screening mammograms occur every year in the U.S. and it’s important to note that despite the technology disbursement, there is a research study going on to inform the science and the clinical practice,” said NCORP Director Worta McCaskill-Stevens, MD, MS.

Toward Personalized Screening Recommendations

TMIST researchers also are collecting evidence of significant secondary endpoints including false positives, recall rates, biopsy rates, and overdiagnosis. Data is collected on the results of every mammogram, whether the imaging shows no signs of cancer, findings suspicious of cancer, or a breast cancer. Medical follow-ups, such as more imaging or biopsies, also are reported.

Portrait of Worta McCaskill-Stevens

NCORP Director Worta McCaskill-Stevens, MD, MS

“Any increase in sensitivity with a new technology could be of benefit, harm, or a mixture, but only a randomized trial can sort it out,” Dr. McCaskill-Stevens added. “The average-risk woman will need personalized guidance about screening tests to make informed decisions around potential risks and benefits in the future.”

A key component of the trial is a biorepository with detailed clinical annotations. The subsequent molecular characterization of specimens and accompanying demographic information could help advance a personalized approach to screening recommendations that determines mammography use and intervals for each person based on their genetics and individual risk factors for developing breast cancer.

“The molecular evidence is the first step to personalizing breast cancer screening recommendations,” Dr. McCaskill-Stevens said. “The resulting dataset of clinical images and biospecimens will help us tailor future screening to each woman’s individual risk.”

More information and a list of participating sites is available from NCI and ECOG-ACRIN. For a discussion about the science involved in the study, see the article “Why I choose to play a dual role in TMIST” by Dr. McCaskill-Stevens in The Cancer Letter. “TMIST Trial Aims to Provide Clarity on Breast Cancer Screening Approaches” in the NCI Cancer Currents Blog offers more background on 2-D vs 3-D technology.

For more information about cancer clinical trials near you, click here.

 TMIST Ramps Up to Illuminate Breast Cancer Screening was originally published by the National Cancer Institute.

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.

FirstHealth joins National Breast Cancer Awareness Month

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FirstHealth of the Carolinas supports Breast Cancer Awareness 2019 Pinehurst, NCLaurinburg Exchange
 October 1, 2019

PINEHURST – The American Cancer Society estimates that by the year’s end in the United States 268,600 new cases of invasive breast cancer will be diagnosed in women and 41,760 will die from the disease. In North Carolina, where breast cancer ranks at the top of all new cancer diagnoses, that breaks down to 8,870 new cases and 1,390 deaths.

“There is a one in eight chance that a woman will be diagnosed with invasive breast cancer during her lifetime,” said Sushma Patel, M.D., a radiation oncologist with FirstHealth of the Carolinas. “While rates of death due to breast cancer are declining due to better screening and improved treatment options, we still have a long way to go.”

To aid in the battle against breast cancer, FirstHealth of the Carolinas joins National Breast Cancer Awareness Month, a campaign held every October to increase awareness of the disease and the importance of early detection.

“Early detection of breast cancer, when it’s small and contained, is the key to improved survival,” said Patel. “It’s essential that women have an annual mammogram, conduct a (monthly) self-exam and watch for changes in their breasts, including swelling, skin thickening or redness, breast warmth or itching and nipple discharge.”

ACS recommends women with an average risk of breast cancer to have yearly mammograms by age 45, but women at a high risk for the disease should talk with their physicians about starting mammograms earlier. Contributing factors to a higher risk include a family history of the disease; a known BRCA1 or BRCA2 gene mutation in the patient or in a first-degree relative (parent, brother, sister or child); radiation therapy to the chest between the ages of 10 and 30 years; or have Li-Fraumeni syndrome, Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome, or first-degree relatives with one of these syndromes.

As men have breast tissue, they are also at risk for the disease, although at a much lesser rate; their lifetime risk is 1 in 833. The ACS estimates that by the end of 2019 about 2,670 new cases of invasive breast cancer will be diagnosed in American men and 500 will die from the disease.

Fortunately for patients in the Sandhills, the FirstHealth Cancer Care team offers comprehensive breast cancer care including screening and diagnostic imaging, breast biopsies, breast cancer surgery, medical and radiation oncology, genetic testing and clinical trials. For patients with any cancer diagnosis, a deep and wide array of support services is at the ready, including oncology nurse navigators who support and guide patients through their cancer journey, a financial navigator, nutritionists, social workers, support groups and spiritual counseling, cancer wellness programs, CareNet volunteers and many other supports that patients are referred to as necessary.

“Patients need to focus on getting well, not worry about barriers to care,” said Lynn Lanier, MSN, R.N., ONN-CG, an oncology nurse navigator at the FirstHealth Outpatient Cancer Center. “These supports are carefully designed to help lessen the anxiety associated with a cancer diagnosis and treatment.”

Sandhills residents can join FirstHealth in the fight against breast cancer in a number of ways:

— Participate in the 1in8k Run for Moore, a 1k fun run and 8k run/walk on Saturday, October 12. This annual community event in the Village of Pinehurst raises funds to fight breast cancer, increases public awareness and allows individuals to honor and support those who have battled or are currently battling the disease. Information is available at www.firsthealth.org/1in8k.

— Get a mammogram at any FirstHealth facility in October and receive a free pink lunch bag. Find locations at www.firsthealth.org/imaging and call (866) 415-2778 to schedule.

“I am looking forward to the day when the ‘1 in 8’ statistic changes to ‘1 in a million’,” said Patel. “We just need to keep working to achieve that goal.”

FirstHealth of the Carolinas is a SCOR member site located in the Pinehurst, NC area.

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.