Dana-Farber Researchers to Present Findings at 2024 San Antonio Breast Cancer Symposium

Researchers from Dana-Farber Cancer Institute will present more than 30 research studies at the 47th annual San Antonio Breast Cancer Symposium, December 10-13, 2024. The San Antonio Breast Cancer Symposium is the world's most comprehensive academic breast cancer meeting, attracting thousands of breast cancer professionals from across the globe.

Select presentations by Dana-Farber researchers include:

GS1-09: OlympiA- Phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients w/ germline BRCA1/BRCA2 pathogenic variants and high-risk HER2-negative primary breast cancer; longer term follow.

Presenter: Judy Garber, MD, MPH
Date and Time: Wednesday, December 11, 7:15 a.m. CST at SABCS Press Program
OlympiA is a multicenter, double-blind study in which 1,836 patients with BRCA-positive, HER2-negative breast cancer were randomly assigned (1:1) to receive either olaparib or placebo for one year following completion of chemotherapy, surgery, and radiation. Based on previous results from the trial, olaparib was approved in 2022 in the adjuvant setting for certain patients with HER2-negative, BRCA-positive breast cancer. Judy Garber, MD Chief, Division for Cancer Genetics and Prevention at Dana-Farber will present the invasive disease-free survival, distant disease-free survival, and overall survival data from OlympiA after a median follow-up of 6.1 years.

GS2-06: Patient Reported Outcomes following Active Monitoring or Surgery for Low-Risk DCIS in the COMET Study (AFT-25)

Presenter: Ann Partridge, MD
Date and Time: Thursday, December 12, 7:15 a.m. 
The large phase 3 COMET (Comparing an Operation to Monitoring, with or without Endocrine Therapy) trial, randomized women to undergo active monitoring for low-risk DCIS (ductal carcinoma in-situ, a form of breast cancer) or to follow current guidelines for care which include surgery with or without radiation. COMET is the first large phase 3 randomized clinical trial in the United States to look at different management strategies for low-risk DCIS.

The study enrolled 957 patients. Over two years, the patients completed questionnaires to report on quality of life, anxiety, depression, worries about DCIS, and symptom trajectories. Ann Partridge, MD, Interim Chair of Medical Oncology at Dana-Farber, will present the patient-reported outcomes from the COMET study.

RF3-01: TBCRC 056: A phase II study of neoadjuvant niraparib with dostarlimab for patients with BRCA- or PALB2-mutated breast cancer: Results from the ER+/HER2- cohort

Presenter: Erica Mayer, MD, MPH
Date and Time: Friday, December 13, 12:00 p.m.

Initial results from a randomized phase 2 trial of presurgical treatment with a niraparib, a PARP inhibitor, plus dostarlimab, an anti-PD-1 antibody, showed encouraging results in a cohort of patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative breast cancer and an inherited increased risk of breast cancer, including an 18.8 percent pathological complete response rate. The findings from the trial, called TBCRC 056, suggest that additional exploration of these non-chemotherapy approaches is warranted.

PARP inhibitors are approved for the treatment of patients with BRCA1/2 or PALB2 mutated breast cancer. Preclinical studies have suggested that PARP inhibitors sensitize tumors to immune checkpoint inhibitors, such as anti-PD-1 antibodies, potentially by bringing immune cells called stromal tumor infiltrating lymphocytes (sTILs) into the tumor. The study measured changes in sTILs three weeks after beginning treatment with niraparib and found a mean absolute increase of 11.9% based on core tumor biopsies. Data from the cohort of patients with triple negative breast cancer with an inherited increased risk of breast cancer will be reported later.

P5-07-28 Next-generation CDK4-selective inhibitor atirmociclib in combination with letrozole as first-line treatment in patients with HR+/HER2− metastatic breast cancer

Presenter: Antonio Giordano, MD, PhD
Date and Time: Friday, December 13, 12:30 p.m.

A novel CDK4-selective inhibitor being tested in combination with the hormone therapy letrozole as first-line treatment in HR-positive/HER2-negative metastatic breast cancer showed favorable safety and tolerability and signs of activity against the disease after a median of 11.1 months follow-up in an ongoing phase 1/2a trial. This novel agent, called atirmociclib (PF-07220060), specifically blocks CDK4 and not CDK6. A previous analysis of a different cohort in this trial showed tolerability and clinical activity in metastatic breast cancer patients who had progressed after two or more lines of previous therapy, including CDK4/6 inhibitors and endocrine therapy.

In this trial, 34 patients were assigned to atirmociclib in combination with letrozole. These patients had not received anti-cancer medicine for metastatic disease and were CDK4/6 inhibitor naive, though 55% had undergone surgery to remove the cancer and 47.1% had prior therapy. Of 32 patients with measurable disease at the start of the trial, half showed a response to the treatment. No severe adverse events occurred, though one patient discontinued the CDK4-inhibitor and three had dose reductions.

RF1-01: Effect of a weight loss intervention (WLI) on metabolic and inflammatory biomarkers in women with obesity and breast cancer: Results from the Breast Cancer Weight Loss (BWEL) Trial (Alliance)

Presenter: Jennifer Ligibel, MD
Date and Time: Wednesday, December 11, 12:00 p.m.
In the phase 3 Breast Cancer Weight Loss Trial (BWEL), a telephone-based weight loss intervention led to significant improvements in metabolic and inflammatory biomarkers known to be associated with cancer recurrence, other health concerns, and survival in patients with obesity who had been treated for early breast cancer. The BWEL trial randomly assigned patients either to a two-year weight loss intervention plus health education or health education alone. A future follow-up of the BWEL trial will evaluate whether changes in these biomarkers predict improvements in cancer outcomes.

The trial enrolled 3,180 women with stage II or III HER2-negative breast cancer and a body mass index indicating obesity or pre-obesity. Compared to the patients assigned to health education, the patients who participated in the weight loss intervention experienced significant reductions in insulin, leptin, insulin resistance, and C-reactive protein levels after both 6 months and two years of follow-up.

LB1-02: MARGOT/TBCRC052: A randomized phase II trial comparing neoadjuvant paclitaxel/margetuximab/pertuzumab (TMP) vs paclitaxel/trastuzumab/pertuzumab (THP) in patients (pts) with stage II-III HER2+ breast cancer

Presenter: Adrienne G. Waks, MD
Date and Time: Tuesday, December 10, 6:00 p.m.

Initial results from a randomized phase 2 trial comparing margetuximab plus chemotherapy or trastuzumab plus chemotherapy in patients with early stage HER2-positive breast cancer found no statistically significant improvement in pathologic complete response between the two regimens. Patients had previously untreated stage II or III HER2-positive breast cancer and either CD16A genotype FF or FV. Margetuximab is similar in action to trastuzumab but is thought to be more efficient at activating the patient’s immune system to kill cancer cells.

This study is the first to compare margetuximab with trastuzumab in newly diagnosed patients with early-stage disease. In previous research, Margetuximab plus chemotherapy modestly improved outcomes compared to trastuzumab plus chemotherapy in patients with heavily treated HER2-positive metastatic breast cancer. This study found similar safety and tolerability between the two regimens. Researchers will continue to follow patients to learn more about survival over time.