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Clinical

GEN-22-TTD0602 - /clinical/breast

In season 3, episode 3 of Targeted Talks, William J. Gradishar, MD, chief of Hematology and Oncology in the Department of Medicine, Betsy Bramsen professor of Breast Oncology, and professor of Medicine (Hematology and Oncology) at Northwestern Medicine, Feinberg School of Medicine, discusses the latest version of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for managing early-stage breast cancer.

Patients with early-stage breast cancer have more options than ever before, but the biggest recent updates have been for patients with estrogen receptor-positive disease, says Gradishar. This is a patient population with a high risk of recurrence, and 2 new therapies with different mechanisms of action have demonstrated the ability to reduce the risk of recurrence.

First, based on the phase monarchE clinical trial (NCT03155997), the FDA granted approval to abemaciclib (Verzenio), in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20% in October of 2021. The study showed that CDK4/6 inhibition is effective for this patient subgroup, according to Gradishar.


For the subgroup of patients with BRCA-mutated tumors, the recent FDA approval of olaparib (Lynparza) for the adjuvant treatment for patients with 

-mutated HER2-negative high-risk early breast cancer that were previously treated with chemotherapy before or after surgery is another important update to the NCCN guideline. Approval of the PARP inhibitor was supported by findings from the phase 3 OlympiA trial (NCT02032823).


Looking ahead, Gradishar still sees room for improving early-stage breast cancer management. Ongoing drug development may offer more promising options for select subgroups in the near future.

In season 3, episode 3 of Targeted Talks, William J. Gradishar, MD, discusses the latest version of the NCCN Clinical Practice Guideline for managing early-stage breast cancer.

Unpacking the New Recommendations for Early-Stage Breast Cancer Management

In season 1, episode 3 of Targeted Talks, the importance of precision medicine in breast cancer, and how that vitally differs in community oncology compared with academic settings, is the topic of discussion. Stephanie L. Graff, MD, director of the Breast Program at the Sarah Cannon Cancer Institute HCA Midwest Health and associate director of the Breast Cancer Research Program at Sarah Cannon Research Institute in Nashville, Tennessee, leads the discussion with Gabriel N. Hortobagyi, MD, FACP, professor of medicine, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, in Houston. The experts concluded from their conversation that the future of precision medicine in breast cancer currently lies with antibody-drug conjugates.

The conversation begins with both doctors explaining the history and the current state of precision medicine in breast cancer as well as the need for targeted therapies in this space to continue the growth of precision medicine. Graff and Hortobagyi also cover the role of genomic testing in aiding in the process of giving individualized care to patients with breast cancer. Ongoing research around targeted therapies in the space was a significant part of the genomic testing conversation, as is the unanswered questions around how to perform testing on these patients in both the community and in academic settings.

The in-depth part of the talk focuses on the novel targeted therapies that are being explored in clinical trials or are newly available in the clinical setting. The doctors specifically touch upon kinase inhibitor research and its use in practice, including drugs like lapatinib (Tykerb), neratinib (Nerlynx), tucatinib (Tukysa), and alpelisib (Piqray), as well as antibody-drug conjugates like ado-trastuzumab emtansine (T-DM1; Kadcyla), sacituzumab govitecan-hziy (Trodely), and trastuzumab deruxtecan (Enhertu). Targeted therapy combinations are also mentioned.

In season 1, episode 3 of Targeted Talks, the importance of precision medicine in breast cancer, and how that vitally differs in community oncology compared with academic settings, is the topic of discussion.

Breast Cancer Leans into the Decade of Antibody-Drug Conjugates, Experts Discuss

Results from a new study could lead to the development of biomarkers for predicting treatment response and the implementation of strategies to address acquired resistance of CDK4/6 inhibitors in HR-positive/HER2-negative breast cancer.

Biological Factors Affect CDK4/6 Inhibitor Response in Breast Cancer

During a Targeted Oncology™ Case-Based Roundtable™ event, Tiffany A. Traina, MD, reviewed data from the TROPiCS-02 and DESTINY-Breast04 and discussed using antibody-drug conjugates in patients with metastatic breast cancer. 

Traina Reviews Current Data for Antibody-Drug Conjugates in Breast Cancer

In the second article of a 2-part series, Aditya Bardia, MD, MPH, leads a discussion on the practice-changing use of sacituzumab govitecan and trastuzumab deruxtecan for patients with advanced breast cancer. 

Adjusting to Practice Changing ADCs in Advanced Breast Cancer

Fertility preservation should be offered to anyone who is interested in becoming pregnant after chemotherapy for breast cancer. 

Fertility and Overtreatment of Premenopausal Breast Cancer

During a Targeted Oncology™ Case-Based Roundtable™ event, Aditya Bardia, MD, MPH, discussed treatment approaches for a patient with hormone receptor–positive, HER2- negative metastatic breast cancer?

Bardia Discusses Importance of SERDs in Patients With HR+/HER2– Metastatic Breast Cancer

Sara Tolaney, MD, MPH, associate director of the Susan F. Smith Center for Women’s Cancers; director of Clinical Trials, Breast Oncology; and senior physician at Dana-Farber Cancer Institute, and assistant professor of medicine at Harvard Medical School, discusses key takeaways from the TROPiCS-02 (NCT03901339) study of sacituzumab govitecan-hziy (Trodelvy) for patients with hormone receptor (HR)-positive/HER2-negative metastatic breast cancer, and highlights other trials evaluating the agent.

According to Tolaney, sacituzumab is an effective and safe treatment option for this patient population, thus 

FDA approval was granted based on findings from the phase 3 stud

Now, experts are further evaluating sacituzumab and trying to move treatment up in earlier settings.

 I think now seeing with longer follow-up that there continues to be improvement in both progression-free and overall survival, favoring sacituzumab over standard chemotherapy, it reinforces that fact that sacituzumab is a very effective treatment option for patients with pretreated metastatic hormone receptor-positive disease.

There's definitely an interest in trying to move sacituzumab up even earlier. Obviously, this was a very pretreated setting with a median of 3 lines of chemotherapy in the metastatic setting and we all would wonder how sacituzumab would do if given earlier. There is a trial called ASCENT-07 [NCT05840211] which is looking at sacituzumab compared with chemotherapy in the first-line of chemotherapy for metastatic hormone receptor-positive disease.

There are also ongoing trials looking at sacituzumab in the first-line, metastatic triple negative breast cancer space, so ASCENT-03 [NCT05382299] and ASCENT-04 [NCT05382286], looking at it in the PD-L1-negative population as well as in the PD-L1-positive population. Then, there's even a trial looking at sacituzumab in early breast cancer. That trial is ASCENT-05 [NCT05633654], looking at patients who had preoperative therapy for triple negative breast cancer and have residual disease. Then, they get randomized to get sacituzumab with pembrolizumab [Keytruda] or to get pembrolizumab plus capcitabine per physicians choice.

Videos

Sara Tolaney, MD, MPH, discusses key takeaways from the TROPiCS-02 study of sacituzumab govitecan-hziy for patients with hormone receptor-positive/HER2-negative metastatic breast cancer, and highlights other trials evaluating the agent.


News

Trials Investigate Sacituzumab as Earlier Treatment for Breast Cancer 

Andreas Varkaris, MD, PhD, attending physician and investigator, Termeer Center for Targeted Therapies, Massachusetts General Hospital, talks about targeting 

signaling in breast cancer and the novel therapies being developed to treat these tumors.

 mutations in patients with breast cancer, especially in those with hormone-receptor, HER2-negative disease, many agents are under clinical development to improve outcomes for patients with 

-mutated breast cancer. There is only 1 drug currently FDA-approved to treat these patient, alpelisib (Piqray), which underscores the need for new drugs.

Varkaris says that newer studies are even beginning to look at PI3K inhibitors in combination with other effective agents to improve the chances of good outcomes for patients with 

-mutated breast cancer. This includes a phase 1 study for which Varkaris is an investigator, (

 mutations are relatively common. They're seen in 14% of all solid tumors. But there are some subtypes of solid tumors that we find 

 more commonly, for example, breast cancer tumors, especially hormone receptor-positive/ HER2-negative, advanced breast cancer tumors, express 

 mutations in up to 40% of the cases. In the past, we have been able to treat these patients with altered generations of PI3K inhibitors. We have an FDA approved drug called alpelisib, which is equally potent against the mutant, the wild-type enzyme, and has prolonged the life of patients with metastatic breast cancer with these mutations.

We look forward to a new generation of inhibitors that will allow us to inhibit the enzyme more potently, without affecting the normal cells, and increase the number of patients that we will be able to treat. Also, by having more targeted therapies, we'll be able to combine these new drugs with other targeted therapies, something that wasn't feasible in the past because of the toxicity profile.

Andreas Varkaris, MD, PhD, discusses PIK3CA mutations in breast cancer and the novel therapies being developed to treat these tumors. 

Targeting PIK3CA Mutations in Breast Cancer

Nicholas J. Robert, MD, chief medical officer of Ontada, discusses a study of the social determinants of a patient’s health related to the use of genomic testing in women with breast cancer.

The study explored the use of germline testing of women with triple-negative breast cancer (TNBC) who were patients in US Oncology Network practices.

 Germline testing is recommended for all patients with TNBC and can identify germline 

 mutations responsible for developing breast cancer. Genomic profiling of patients with TNBC can inform how physicians manage patients during breast cancer surveillance and treatment.

The investigators looked at a group of women aged 60 or younger and found 74% overall had received germline testing, which was significantly higher than the 24% who received it according to a study published in 2018. Robert says the higher rate of testing could be partially explained by surveying patients in practices with active genetic screening programs.

The investigators reported at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO) that only 67% of African American women received germline testing compared with 75% of white women. Other factors such as geographic region and socioeconomic conditions also impacted the rate of testing, with lower rates in the South and Midwest regions. Robert says they plan to analyze these data with a multivariate analysis to see precisely which factors affect how patients receive genomic testing.

According to Robert, this aspect of the study raised awareness that there is a greater need to identify all patients who should receive germline genetic testing and avoid excluding any patients who may be at higher risk during surveillance and treatment because of genetic factors.

We identified a group of women that included African Americans, and we identified testing rates for germline testing. We did find that overall, the group did very well, [over] 70% got germline testing, much higher than we would expect. Partly that was due because these patients were or are in practices that had a very active genetic screening program. But we did find that African American women were tested a bit less than White women. We did find some other factors, in terms of where the region they live, for example. This has been reported at ASCO, and we will subsequently do a what we call a multivariate analysis to see if there if we can understand this better. But it certainly has raised awareness within our network that we need to identify all patients that are appropriate for testing.

1. Reid RL, Dye J, Leong T, et al. The impact of social determinants of health (SDOH) on use of germline genetic testing for triple-negative breast cancer (TNBC) in the community oncology setting. 

 2023;41(suppl_16):1094. doi:10.1200/JCO.2023.41.16_suppl.1094

Nicholas J. Robert, MD, discusses a study of the social determinants of a patient’s health related to the use of genomic testing in women with breast cancer. 

Racial Disparity Seen in Use of Germline Testing in TNBC

Sara Tolaney, MD, MPH, associate director of the Susan F. Smith Center for Women’s Cancers; director of Clinical Trials, Breast Oncology; and senior physician at Dana-Farber Cancer Institute, and assistant professor of medicine at Harvard Medical School, discusses sacituzumab govitecan-hziy (Trodelvy) as an effective and safe treatment for patients with hormone receptor (HR)-positive/HER2-negative metastatic breast cancer.

Data from the final overall survival (OS) analysis of TROPiCS-02 (NCT03901339) revealed there to be a confirmed clinically meaningful OS benefit with sacituzumab govitecan vs with single-agent chemotherapy in this patient population, further supporting the FDA approval.

FDA granted approval to sacituzumab goviteca

TROPiCS-02 is a phase 3 study that compared sacituzumab govitecan to treatment of physicians choice chemotherapy in patients with metastatic hormone receptor-positive disease. Eligible patients were required to have had prior CDK4/6 inhibition, prior endocrine therapy, prior taxane, and also 2 to 4 prior lines of chemotherapy in the metastatic setting, and also needed measurable disease. They were then randomized in a 1:1 fashion to get sacituzumab govitecan given at the standard schedule of 10 mg/kg [intravenously] on days 1 and 8 of a 21 day cycle, or to get treatment of physicians choice chemotherapy. The primary end point was progression-free survival. Key secondary end points did include overall survival and objective response rate.

At the time of this analysis, which again is a final exploratory overall survival analysis, there was a median follow-up time of 13 months. At this time, there were about 438 overall survival events. We did see that sacituzumab govitecan did improve overall survival. It was 14.5 months with sacituzumab govitecan compared with 11.2 months with treatment of physicians choice chemotherapy, with a hazard ratio of 0.79, suggesting statistically significant improvements in overall survival, but I think also clinically meaningful differences in overall survival.

Sara Tolaney, MD, MPH, discusses sacituzumab govitecan-hziy as an effective and safe treatment for patients with hormone receptor-positive/HER2-negative metastatic breast cancer.


Overview of TROPiCS-02 Study of Sacituzumab Govitecan in HR+/HER2- mBC

Nicholas J. Roberts, chief medical officer, Ontada, discusses real-world research around the adoption of germline testing for breast cancer, and the testing gap in certain racial groups.

 Ontada does a lot of real-world evidence. We’re a data analytic technology company within McKesson, and one of the things we felt that we should offer the physicians and US Oncology Network, is the opportunity to do what we call investigator-initiated studies. So, over a year ago, we sent out a proposal to our physicians to see if they would want to come up with a study that addressed the issues of social determinants of health.

 As everyone I think now knows, not everyone gets access to care, there are a number of barriers to care. We felt it was important to address in different cancers, whether social determinants of health were playing a role in maybe being a barrier to getting the appropriate care. We ended up with 3 studies, and 2 of the studies are around the issue of triple-negative breast cancer.

 So, triple negative breast cancer is an aggressive breast cancer. It affects disproportionately women that are African American. And we want to see if there was the appropriate standard of care in their management. So, we identified a group of women that were at triple-negative breast cancer, and we asked 2 questions. One is related to what we call germline testing. That's testing to see if someone has an inherent risk for getting breast cancer. And it turns out that triple-negative breast cancer, there is a concern that that may be at play. We identified a group of women that included African Americans, and we identified that testing rates for germline testing. And we did find that overall, the group did very well 70% plus got germline testing, much higher than we would expect. Partly, that was because these patients were in practices that had a very active genetic screening program. But we did find that African American women were tested a bit less than White women.

Nicholas J. Roberts, discusses real-world research around the adoption of germline testing for breast cancer, and the testing gap in certain racial groups.

Study Reveals Disparities in the Use of Germline Testing for Breast Cancer

Dennis J. Slamon, MD, director of clinical/translational research, UCLA Jonsson Comprehensive Cancer Center and chairman and executive director of Translational Research in Oncology, discusses the rationale of the phase 3 NATALEE trial (NCT03701334) and describes ribociclib (Kisqali) for the treatment of patients with hormone receptor (HR)-positive/HER2-negative early breast cancer.

The multicenter, randomized, open-label, phase 3 NATALEE trial compared treatment with ribociclib plus endocrine therapy with endocrine therapy alone in adult patients with HR-positive/HER2-negative early breast cancer. Patients were eligible for enrollment if they had an anatomic stage group II or III disease following surgical resection, an ECOG performance status of 1 or 0, and have available archival tissue from surgical resection.

In the study, patients were given ribociclib at a dose of 400 mg daily in a 3-weeks-on-1-week off manner for 3 years. Both arms of the study administered patients standard-of-care endocrine therapy which consisted of letrozole or anastrozole for a duration of at least 5 years plus goserelin.

The NATALEE trial is a study to assess the efficacy and safety of 1 of the 3 approved inhibitors of the CDK4/6 kinases in patients with early breast cancer when they're initially diagnosed. We know that this drug has a significant benefit in metastatic disease. The question is, will it benefit patients with early disease at the time of diagnosis? That's what the study was designed to answer.

 The drug itself is an oral drug that you take that will interact with these kinases. These are enzymes that are important in progressing cells through the cell cycle, allowing cells to divide in other words. Hormone receptor-positive HER2-negative breast cancer cells are using this pathway a lot. Blocking these enzymes appears to have a pretty important impact on those, and that's what the study was designed to assess in a clinical setting.

Dennis J. Slamon, MD, discusses the rationale of the phase 3 NATALEE trial and ribociclib for the treatment of patients with HR+/HER2- early breast cancer.


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