Dr Grinshpun on Ultra-Sensitive ctDNA Detection in HR+ Early Breast Cancer

"This clinical trial offers an opportunity for patients to receive a targeted therapy like lasofoxifene along with abemaciclib, which is a very unique CDK4/6 inhibitor that has shown a clinical response beyond progression on frontline CDK4/6 therapy."

Sagar D. Sardesai, MBBS, breast medical oncologist, Division of Medical Oncology, The Ohio State University (OSU); member, Cancer Control Program, Ohio State University Comprehensive Cancer Center–James, discusses the phase 3 ELAINEIII trial (NCT05696626) evaluating lasofoxifene in combination with abemaciclib (Verzenio) for patients with 

-mutant, estrogen receptor (ER)–positive, HER2-negative locally advanced or metastatic breast cancer.

To enroll in this open-label, multicenter, global randomized study, patients must have received frontline therapy with an aromatase inhibitor and a CDK4/6 inhibitor other than abemaciclib and have tumors harboring an activating 

 mutation, a key eligibility criterion, Sardesai details. The study aims to compare the progression-free survival (PFS) outcomes of 2 treatment regimens: the oral next-generation selective estrogen receptor modulator and antagonist lasofoxifene combined with abemaciclib, vs fulvestrant (Faslodex) in combination with abemaciclib, he says.

Elacestrant (Orserdu) is currently the only FDA-approved endocrine therapy available for patients with ER-positive, HER2-negative metastatic breast cancer and 

 mutations, Sardesai states. Although elacestrant demonstrates meaningful clinical benefit in terms of survival and response rates for some patients, no approved combination regimens exist for this population, he notes. ELAINEIII represents a unique opportunity to assess targeted combination therapy with lasofoxifene, an oral agent with a novel mechanism of action, alongside abemaciclib, a CDK4/6 inhibitor that has demonstrated clinical activity beyond progression on frontline CDK4/6 inhibitor therapy, Sardesai explains.

Abemaciclib has distinct characteristics compared with other CDK4/6 inhibitors, as it has shown efficacy in patients whose disease progressed following prior CDK4/6-based therapy, Sardesai continues. By pairing abemaciclib with lasofoxifene, the trial explores a potentially more effective strategy for managing resistance driven by 

 mutations. This combination may offer patients prolonged disease control and clinical benefit compared with the current standard of fulvestrant and abemaciclib, Sardesai adds.

Positive outcomes from this study could provide an alternative therapeutic option and further define the role of lasofoxifene in combination with abemaciclib for this patient population, Sardesai concludes.

Videos

Sagar D. Sardesai, MBBS, discusses the phase 3 ELAINE-3 trial evaluating lasofoxifene plus abemaciclib in ESR1-mutant, ER-positive, HER2-negative breast cancer.

Dr Sardesai on Lasofoxifene Plus Abemaciclib in ESR1-Mutant, ER+/HER2– Breast Cancer  

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In today’s episode, we had the pleasure of speaking with Sagar D. Sardesai, MBBS, about the phase 3 ELAINE-3 trial (NCT05696626) and its evaluation of lasofoxifene in combination with abemaciclib (Verzenio) for patients with 

-mutant, estrogen receptor (ER)–positive, HER2-negative locally advanced or metastatic breast cancer. Dr Sardesai is a breast medical oncologist and researcher in the Division of Medical Oncology at The Ohio State University (OSU) and a member of the Cancer Control Program at OSU Comprehensive Cancer Center – James in Columbus.

The trial aims to compare progression-free survival (PFS) outcomes for lasofoxifene plus abemaciclib vs fluvestrant (Faslodex) plus abemaciclib in patients who have previously received a frontline aromatase inhibitor in combination with a CDK4/6 inhibitor other than abemaciclib.

In our exclusive interview, Dr Sardesai provided insights into ELAINE-3's objectives, the challenges of patient enrollment, and the potential implications for lasofoxifene in clinical practice. He emphasized the importance of personalized treatment approaches, especially in patients harboring 

 mutations, and how the combination therapy with lasofoxifene and abemaciclib could potentially address the unmet need for effective, targeted therapies.

That’s all we have for today! Thank you for listening to this episode of 

 On Air. Check back on Mondays and Thursdays for exclusive interviews with leading experts in the oncology field.

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Podcasts

Sagar D. Sardesai, MBBS, discusses the phase 3 ELAINE-3 trial evaluating lasofoxifene plus abemaciclib in ESR1-mutant, ER+/HER2- metastatic breast cancer.

Sagar D. Sardesai, MBBS

Articles

Dr Sardesai on Lasofoxifene Plus Abemaciclib in ESR1-Mutant, ER+/HER2– Breast Cancer

Exploring Lasofoxifene Plus Abemaciclib in ESR1+ Breast Cancer: Insights from ELAINE-3 With Sagar D. Sardesai, MBBS