Could Your Patient Benefit? New Clinical Trials in Breast Cancer

Could Your Patient Benefit? New Clinical Trials in Breast Cancer

A number of phase 3 studies in breast cancer have opened in recent months. Maybe one of your patients could benefit from being enrolled?

Advanced HER2+ breast cancer. Patients with previously treated advanced or metastatic HER2+ breast cancer with and without brain metastases are sought for the DESTINY-B12 trial of trastuzumab deruxtecan (Enhertu). Patients will be treated for approximately 2.5 years, depending on the time to progression or death. Recruitment began on June 22, with the aim of recruiting 500 patients globally; US sites are in Massachusetts, North Carolina, and Virginia. Overall survival (OS) and quality of life (QoL) will be tracked. More details at clinical

This is an important study, says Medscape contributor Kathy Miller, MD, professor of oncology and medicine at the Indiana University School of Medicine, Indianapolis. “If positive [it] will change the standard of care and expand options for that subgroup of patients,” she said.

Locally recurrent or metastatic HR+, HER2- breast cancer. Patients with locally recurrent inoperable or metastatic HR+, HER2- breast cancer eligible for chemotherapy are being recruited for the KEYNOTE-B49 trial, which will look at adding pembrolizumab (Keytruda) onto chemotherapy. Patients will receive therapy for up to 2 years. Progression-free survival is the primary outcome measure, with OS and QoL as secondary measures. More details at clinical

“This study is based more on hope than preliminary data,” Miller said. “While immunotherapy has had some benefit in triple negative breast cancer (TNBC), there is little data to support benefit in ER+ disease. It would be great for our patients if I am wrong about this one.”

Locally advanced or metastatic HER2+, PD-L1+ breast cancer. Patients with locally advanced or metastatic HER2+, PD-L1+ breast cancer are sought for KATE3which is testing trastuzumab emtansine (T-DM1, Kadcyla) with atezolizumab (Tecentriq). Study sites are in California, Georgia, Missouri, New Mexico, New York, and Pennsylvania. Patients will be treated “until disease progression, unmanageable toxicity or study termination by the sponsor.” This is the only trial in the list for which OS is a primary outcome; clinically meaningful QoL will also be logged. More details at clinical

HR+, HER2- breast cancer. Premenopausal women with HR+, HER2- breast cancer, and men with HR+ breast cancer are being sought for the OVELIA trial, which is testing a new subcutaneous formulation of leuprolide acetate, known as TOL2506. All patients will receive the new product for the 48 weeks of this single-arm trial. After that period, patients can get expanded access until the drug is commercially available. Study sites are in Illinois, Kansas, Kentucky, and Michigan. The study outcome is suppression of ovarian function; researchers will not assess QoL or OS. More details at clinical

ER+, HER2- early breast cancer. Patients with medium- or high-risk ER+, HER2- early breast cancer are sought for the lidERA Breast Cancer study. This trial, based in California, Kansas, Montana, and Nevada, is looking at giredestrant, a new selective estrogen receptor downregulator (SERD). This oral therapy is a potential alternative to monthly intramuscular fulvestrant (Faslodex), the only SERD currently available in the United States. Patients will be treated for up to 5 years or until disease recurrence. The trial will measure OS and QoL, as well as the primary outcome of invasive-disease-free survival. More details at clinical

HR+, HER2- metastatic breast cancer. Patients with HR+, HER2- metastatic breast cancer who have not progressed during first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor are sought for the SERENA-6 trial. The trial is testing a new oral SERD (known only as AZD9833) in a protocol that is described by the sponsors as a “ctDNA-guided early-switch study.” Patients will be monitored for the development of an ESR1 mutation, a measure of acquired resistance to hormone therapy, and then switched to the study drug to see if it improves response. Patients will be treated until disease progression or death, whichever occurs first. The trial will also measure OS and QoL. More details at

Breast Cancer Facts


    • Approximately 2,200 men are diagnosed with breast cancer.
    • 63% of breast cancer cases are diagnosed at a localized stage.
    • Every 2 minutes, a woman in the United States is diagnosed with breast cancer.
    • 1 in 8 women will develop breast cancer in the US.

Source: National Breast Cancer Org

Breast Cancer Awareness


Breast Cancer Awareness

This October, we are raising awareness for National Breast Cancer Awareness Month. Breast cancer is when malignant cells form in the breast tissue. The exact cause of breast cancer is not known. This month we want to raise awareness for early detection, possible causes, and treatment.

Most breast cancer symptoms are visible signs but still need professional screening for a diagnosis. Some early/visible symptoms include a lump on the breast, nipple discoloration, or nipple discharge. If you detect any of these symptoms, we suggest you seek healthcare professional.

To date, the cause of breast cancer is still unknown. There might be genetic factors that come into play. The TNM (tumor, lymph node, metastasis) system helps health professionals figure out the breast cancer stage of each individual. Generally, there are five types of treatments. It often includes a combination of chemotherapy, surgery, radiation, and targeted therapies.

Join us this October to raise awareness and support breast cancer patients and survivors.

Big Data Helps Identify Better Way to Research Breast Cancer’s Spread

Big Data Helps Identify Better Way to Research Breast Cancer’s Spread

Scientists are using a lot of genomic data to identify medical issues sooner in patients, but they’re also using it to assist their scientific counterparts in researching diseases better.

In a new study, Michigan State University researchers are analyzing large volumes of data, often referred to as big data, to determine better research models to fight the spread of breast cancer and test potential drugs. Current models used in the lab frequently involve culturing cells on flat dishes, or cell lines, to model tumor growth in patients.

The study is published in Nature Communications.

This spreading, or metastasis, is the most common cause of cancer-related death, with around 90% of patients not surviving. To date, few drugs can treat cancer metastasis, and knowing which step could go wrong in the drug discovery process can be a shot in the dark.

“The differences between cell lines and tumor samples have raised the critical question to what extent cell lines can capture the makeup of tumors,” Bin Chen, senior author and assistant professor in the College of Human Medicine, said.

To answer this question, Chen and Ke Liu, first author of the study and a postdoctoral scholar, performed an integrative analysis of data taken from genomic databases including The Cancer Genome Atlas, Cancer Cell Line Encyclopedia, Gene Expression Omnibus, and the database of Genotypes and Phenotypes.

“Leveraging open genomic data to discover new cancer therapies is our ultimate goal,” Chen, who is part of MSU’s Global Impact Initiative, said. “But before we begin to pour a significant amount of money into expensive experiments, we need to evaluate early research models and choose the appropriate one for drug testing based on genomic features.”

By using this data, the researchers found substantial differences between lab-created breast cancer cell lines and actual advanced, or metastatic, breast cancer tumor samples. Surprisingly, MDA-MB-231, a cancer cell line used in nearly all metastatic breast cancer research, showed little genomic similarities to patient tumor samples.

“I couldn’t believe the result,” Chen said. “All evidence pointed to large differences between the two. But, on the flip side, we were able to identify other cell lines that closely resembled the tumors and could be considered, along with other criteria, as better options for this research.”

The organoid model was found to most likely mirror patient samples. This newly developed technology uses 3D tissue cultures and can capture more of the complexities of how tumors form and grow.

“Studies have shown that organoids can preserve the structural and genetic makeup of the original tumor,” Chen said. “We found at the gene expression level, it was able to do this, more so than cancer cell lines.”

However, Chen and Liu added that both the organoids and cell lines couldn’t adequately model the immediate molecular landscape surrounding a tumor found at different sites in the body.

They said knowing all these factors will help scientists interpret results, especially unexpected ones, and urge the scientific community to develop more sophisticated research models.

“Our study demonstrates the power of leveraging open data to gain insights on cancer,” Chen said. “Any advances we can make in early research will help us facilitate the discovery of better therapies for people with breast cancer down the road.”

Source: Drug&DiscoveryTrends