Chemotherapy-Resistant Breast Cancer: BEAUTY2 Study

Judy C. Boughey, M.D.

BEAUTY2 Study Co-Chair

Matthew P. Goetz, M.D.

BEAUTY2 Study Co-Chair

The Breast Cancer Genome-Guided Therapy Study 2 (BEAUTY2) is an exciting group of studies designed to test new drugs for women with chemotherapy-resistant breast cancer. The first drug being tested is abemaciclib — an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) with the brand name Verzenio.

Neoadjuvant chemotherapy is the standard treatment for women with certain types of breast cancer.

For patients with no cancer after standard chemotherapy, the prognosis is excellent. However, for patients with residual cancer after standard chemotherapy, additional therapy to eradicate disease may reduce the risk of future breast cancer events.

Abemaciclib has been approved in the U.S. by the Food and Drug Administration for the treatment of metastatic breast cancer that is resistant to estrogen-targeted therapies. Based on scientific findings from the first BEAUTY study, BEAUTY2 is testing the effects of abemaciclib in patients who have tumors that are estrogen receptor negative and who have residual disease after neoadjuvant chemotherapy.

Participation

All women with triple-negative invasive breast cancer treated with anthracycline- and taxane-based chemotherapy are eligible to participate in this trial, as long as they:

  • Have completed chemotherapy and not yet had surgery
  • Are not pregnant or breast-feeding

After completion of standard chemotherapy, each participant will be assessed by breast imaging and a breast biopsy to see how well the tumor has responded to the chemotherapy treatment. Participants with disease remaining will be treated with abemaciclib, which has shown promise for treating triple-negative breast cancer that is resistant to chemotherapy. Participants who have no or minimal residual disease, as determined by the imaging and biopsy, will proceed to surgery.

View a complete list of preregistration and registration inclusion and exclusion criteria.

Overview of BEAUTY2 study

Contact

Patients and referring physicians can contact the Clinical Trials Referral Office at Mayo Clinic for more information at 855-776-0015 (toll-free).

Contact form

BEAUTY2 study clinical trial page

BEAUTY2 brochure

You can also contact the Center for Individualized Medicine for information on other studies and trials.

BEAUTY2 Study for Chemotherapy-Resistant Breast Cancer

Dr. Boughey: Hello, my name is Judy Boughey and I'm a breast surgeon at Mayo Clinic in Rochester.

Dr. Goetz: And I'm Matthew Goetz, a breast medical oncologist.

Dr. Boughey: We are the leaders of the BEAUTY2 clinical trial. I want to take a few moments to describe this impactful study and the opportunity it provides.

Dr. Goetz: BEAUTY2 is a clinical trial that is focused on patients who have completed chemotherapy for a diagnosis of triple negative breast cancer and are planning to undergo surgery. This trial is focused on those women who likely have some cancer remaining in the breast prior to surgery. This group of women is at high risk of recurrence, and our focus is to improve the outcome for these women.

Dr. Boughey: The BEAUTY2 clinical trial is designed to test a drug called abemacyclib.

Dr. Goetz: Abemaciclib is a CDK4 and 6 inhibitor which is FDA approved for women with a diagnosis of estrogen receptor positive breast cancer that has spread. Importantly, abemacyclib has been shown to prolong the survival in women whose breast cancer is resistant to standard endocrine therapies.

Dr. Boughey: At this time you may ask why are we studying a drug for estrogen receptor positive breast cancer in women with triple negative breast cancer?

Dr. Goetz: Well, in our previous study from the BEAUTY team, BEAUTY1, we determined that CDK4 and 6 inhibitors had a new and previously unidentified anti-cancer effect, inhibiting the metastatic spread of triple negative breast cancer. Additional work has shown that abemaciclib may also activate the immune system. Also, there are data demonstrating that abemacyclib may inhibit the growth of certain triple negative breast cancers.

Dr. Boughey: So the goal of BEAUTY2 is to study this drug, abemacyclib, for women with triple negative breast cancer who have disease remaining in the breast after standard chemotherapy. The overall goal of our study is to determine whether abemacyclib is able to activate the immune system and inhibit the proteins critical to the metastatic spread of triple negative breast cancer.

Dr. Goetz: This is a study where you would take abemacyclib, an oral tablet, twice a day for two to three weeks in the window between finishing chemotherapy and your surgery. It will not delay your surgery.

Dr. Boughey: We are looking for women with triple negative breast cancer who may have some cancer remaining in the breast after chemotherapy based on imaging such as mammogram, ultrasound or MRI performed after chemotherapy was completed.

Dr. Goetz: In order to find out more information about this study, please look at the following website that is shown on your screen. Fill out a contact form or leave a message for our study team at 855-776-0015. You may feel more comfortable having your medical oncologist contact the BEAUTY2 team, and this is fine also. Patients on this study need to have their surgery at Mayo Clinic in Rochester, Minnesota; Jacksonville, Florida; or Phoenix, Arizona.

Dr. Boughey: If you are interested, contact the BEAUTY team while you are on chemotherapy for your triple negative breast cancer so we can coordinate your optimal care while being a part of this breast cancer study.

Dr. Goetz: Thank you for your interest in BEAUTY2.