The American Society of Clinical Oncology (ASCO) is an international organization representing nearly 45,000 physicians and other healthcare professionals in oncology—including many BCRF investigators. ASCO recently held its annual meeting, convening its members in Chicago to share findings and discuss the rapidly changing cancer research landscape. BCRF investigators presented many of the meeting’s most exciting sessions on breast cancer and several received top awards.
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Here, BCRF highlights the most noteworthy breast cancer news that came out of ASCO earlier this month.
BCRF investigator Dr. Sara Tolaney presented the potentially practice-changing results from two ongoing trials:
Dr. Erica Hamilton of Sarah Cannon Research Institute presented the results from the VERITAC-2 trial testing an experimental drug called a PROTAC (proteolysis-targeting chimera), which acts by degrading its target. The drug, vepdegestrant, was compared to fulvestrant (Faslodex®) in patients with metastatic hormone receptor (HR)–positive/HER2-negative breast cancer with ESR1 mutations that had stopped responding to hormone and CDK4/6 inhibitor treatment.
Progression-free survival (the amount of time during and after treatment when a patient lives with a disease) was five months for those treated with vepdegestrant versus two months with fulvestrant. The overall response rate for those treated with vepdegestrant was about 19 percent compared to four percent with fulvestrant. And patients treated with vepdegestrant had better progression-free survival than those who received fulvestrant.
The INAVO120 trial was presented by BCRF investigator Dr. Nicholas Turner. In patients with advanced HR-positive/ HER2-negative breast cancer with a PIK3CA mutation that progressed on or after hormone therapy, adding inavolisib (Itovebi®) to palbociclib (Ibrance®) and fulvestrant improved overall survival by about seven months and delayed the need for chemotherapy by nearly two years. Adding inavolisib also significantly improved the number of cancers that shrank by more than 30 percent in response to treatment.
Circulating tumor DNA (ctDNA), bits of tumor DNA found in the blood through liquid biopsy, has intrigued the breast cancer community for decades. What can it tell us about how a patient will respond to treatment or if their cancer will return? Researchers shared new studies that may help answer these questions and support the use of ctDNA in breast cancer care.
BCRF investigator Dr. Nicholas Turner presented the results of SERENA 6, which demonstrated the clinical utility of using ctDNA to detect emerging treatment resistance ahead of disease progression—a major development.
Patients with advanced HR-positive/HER2-negative breast cancers are often prescribed a combination of an aromatase inhibitor plus a CDK4/6 inhibitor. One of the most common reasons that these patients stop responding to this treatment combination is because their cancer develops mutations in the estrogen receptor (ER) known as ESR1 mutations (ESR1m).
Dr. Turner and his team found that ESR1m could be picked up by ctDNA analysis. By doing regular ctDNA analysis on these patients, researchers could track the emergence of ESR1m and CDK4/6 inhibitor resistance in real time—allowing clinicians to change treatments at the first sign of resistance and not months later after standard-of-care scans. This was particularly significant in this study because the team could switch to camizestrant, an experimental drug known to work in tumors regardless of ESR1m status.
Dr. Natasha Hunter of the University of Washington presented the first results from the PREDICT-DNA trial, supported by BCRF through the Translational Breast Cancer Research Consortium. The trial included patients with stage 2/3 TNBC and those with HER2-positive breast cancer. Researchers examined invasive disease-free survival (the amount of time a patient has no symptoms) by breast cancer subtype and correlated it with ctDNA presence after neoadjuvant therapy (post-surgery), and pathologic complete response (pCR; no evidence of disease), when no evidence of disease is found.
They found that the lack of ctDNA detection after neoadjuvant therapy and before surgery did not predict pCR. However, the initial analysis suggests that ctDNA-negative patients before surgery have an excellent prognosis regardless of pCR, particularly in TNBC. This suggests that ctDNA may be a better biomarker for long-term clinical outcomes than pCR, but more research is necessary.
BCRF investigator Dr. Lajos Pusztai presented preliminary results from the DARE trial, a prospective, multicenter, randomized ctDNA interventional trial in patients with ER-positive/HER2-negative breast cancer who are at a high risk of relapse. They used ctDNA to identify these high-risk patients and examined the dynamics of ctDNA during treatment. Dr. Pusztai showed that 99 percent of patients who did not have ctDNA in their blood achieved relapse-free survival (RFS) after a median follow-up of 27.4 months. This provides further evidence that ctDNA monitoring and ctDNA dynamics can predict patient outcomes.
What if patients could take smaller doses of certain drugs and still see the same survival benefits? What if ramping up doses over a few weeks helped patients stay on lifesaving treatments and experience fewer side effects? These questions were top of mind throughout the conference, as researchers presented results from studies that looked at different dosing strategies.
BCRF investigator Dr. Andrea DeCensi presented findings from the phase 3 TAM01 trial of low-dose tamoxifen (babyTam) in women with high-risk lesions, including ductal carcinoma in situ, atypical ductal hyperplasia, and lobular carcinoma in situ. Patients with these noninvasive forms of breast cancer have a five to 10 times higher risk of developing invasive breast cancer compared to the general population.
Dr. DeCensi reported that babyTAM at doses of one and five milligrams is as effective as 20 milligrams, with a slight increase in hot flashes but no significant increase in other common side effects. A follow-up of seven years showed that these women still saw a significant reduction in progression to invasive breast cancer. Ongoing follow-up is planned. These results suggest that babyTam may have a primary prevention role in high-risk women.
Dr. Erica Mayer of Dana-Farber Cancer Center presented results of the phase 2 TRADE trial assessing how patients with early-stage HR-positive/HER2-negative breast cancer tolerated escalating doses of abemaciclib (Verzenio®). Dose escalation allowed 70.8 percent of patients to reach and maintain the target dose (150 mg) at 12 weeks. What’s more: 93.3 percent of patients were still on the treatment at 12 weeks, and researchers noted that patients experienced fewer and less-severe side effects. Further follow-up will assess long-term tolerability and dosing maintenance beyond 12 weeks.
Dr. Rachel Abelman of Massachusetts General Hospital presented results from the NeoStar trial testing neoadjuvant therapy with the ADC sacituzumab govetican (SG/Trodelvy®) plus pembrolizumab (Keytruda®) in patients with early-stage TNBC. Both drugs are currently approved for metastatic TNBC. This is the first trial to test the combination in the neoadjuvant (pre-surgery) setting in patients with early TNBC.
The results were promising, with 34 percent of patients reaching pathological complete response (no evidence of disease). Additional research is needed to determine the optimal duration and sequence of this combination with chemotherapy.
BCRF investigator Dr. Prudence Francis presented long-term results from the BCRF-supported SOFT and TEXT trials in younger women with hormone sensitive early breast cancer. Adding ovarian function suppression with the drug exemestane (Aromasin®) to tamoxifen treatment reduced the 15-year breast cancer recurrence rate and improved overall survival, most notably in young and high-risk patients.
BCRF investigator and Scientific Advisory Board member Dr. Dawn Hershman received the prestigious David Karnofsky Science of Oncology Award for advancing our understanding of women’s cancers and factors influencing cancer outcomes. In her award lecture, “The Art and Science of Patient Centered Listening,” Dr. Hershman acknowledged the numerous obstacles that stand in the way of optimal care for patients with cancer—from medication side effects to financial toxicity—and stressed the importance of patients’ experiences.
“Many of the ideas [in my research] have come from listening to patients and talking to them about what they do or take to make their symptoms better,” she said. “Why do we do what we do? What fuels our purpose? We are deeply privileged to impact patients’ lives, to support the families who trust us, to be part of a community committed to healing and hope, and to make a difference for people we may never meet. It is this unwavering sense of mission that anchors our work and propels us forward.”
The Gianni Bonadonna Breast Cancer Award was given to BCRF investigator Dr. Ian Krop for his leadership that has reshaped patient care around the world. Dr. Krop is a translational investigator focused on developing novel molecularly targeted therapies and immunotherapies for breast cancer and illuminating how patients develop resistance to these treatments. He has been a leader in the development of antibody-drug conjugates in breast cancer including T-DM1 (Kadcyla®) and T-DXd (Enhertu®) and in his award lecture, he stressed the importance of investigator-initiated trials in moving treatments forward.
BCRF investigator and Scientific Advisory Board member Dr. Susan Domchek received the ASCO–American Cancer Society Prevention Award for her pioneering work to improve the genetic evaluation and medical care of individuals with inherited risk factors for breast and ovarian cancers. In her seminal work, Dr. Domchek demonstrated that risk-reducing salpingo-oophorectomy is associated with improved survival in BRCA1 and BRCA2 mutation carriers. This work has been critical in the development of PARP inhibitors for treating BRCA-associated cancers.
Six BCRF investigators were awarded Fellows of ASCO designation, which highlights members who have contributed to oncology, patient care, and mentorship. Drs. Kevin Kalinsky, Heather McArthur, Rita Nanda, Mark Pegram, Joseph Sparano, and Sara Tolaney received these honors.
For many years, BCRF has proudly supported Conquer Cancer, the ASCO Foundation, which awards grants to researchers across the world. At this year’s meeting, BCRF was recognized as Conquer Cancer’s top donor for funding that has bolstered the careers of many early-career investigators.
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