Alliance E-News | December 2024
Scientific Annual Meetings

 

Investigators from Alliance for Clinical Trials in Oncology and Alliance Foundation Trials, LLC (AFT) working to advance research in the treatment and prevention of breast cancer presented on various topics at this year's San Antonio Breast Cancer Symposium (SABCS) held December 10-13.

Designed to provide state-of-the-art information on the experimental biology, etiology, prevention, diagnosis, and therapy of breast cancer and premalignant breast disease, to an international audience of academic and private physicians and researchers, Alliance and AFT presented nine abstracts, including one late-breaking presentation.

GS2-05: Early Oncologic Outcomes Following Active Monitoring or Surgery (+/- Radiation) for Low Risk DCIS: the Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET) Study (AFT-25)
Presenting Author: Eun-Sil Hwang, MD
Dr. Hwang (Duke University School of Medicine) shared findings from COMET, a prospective randomized noninferiority study comparing guideline-concordant care to active monitoring in patients with low-risk DCIS. COMET randomly assigned 995 patients with grade 1 or 2, HR+, HER2- DCIS with no evidence of invasive cancer to undergo active monitoring (n=484) or receive guideline-concordant care consisting of surgery with or without adjuvant radiation (n=473). Patients in the active monitoring arm could elect to have surgery at any time, and surgery was required if the tumor showed signs of invasive progression. Endocrine therapy was allowed for patients in either arm. 

GS2-06: Patient Reported Outcomes Following Active Monitoring or Surgery (+/- Radiation) for Low Risk DCIS in the Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET) Study (AFT-25)
Presenting Author: Ann Partridge, MD
Dr. Partridge (Dana-Farber Cancer Institute) shared a presentation on patient-reported outcomes (PROs) from the COMET study. The PROs were a prespecified secondary endpoint in the study; PRO comparison was conducted by group using prospectively collected validated questionnaires, administered in person or virtually, at enrollment, 6, 12, and 24 months. Both ITT and sensitivity analyses were carried out to evaluate differences in PROs by group over time. The PRO findings showed that, overall QoL, anxiety, depression, breast cancer worries, and symptom trajectories were comparable between patients who received guideline-concordant care and those who underwent active monitoring, with no evidence of substantial negative impact of one approach over the other at two years.

GS2-12 AFT-38 PATINA: A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor-Positive (HR+)/HER2-Positive Metastatic Breast Cancer
Presenting Author: Otto Metzger, MD
Dr. Metzger (Dana-Farber Cancer Institute), an Executive Officer for Alliance Foundation Trials and Study Chair for AFT-38 PATINA, shared potentially practice-changing data from the phase III academic AFT-38 PATINA study, which demonstrated a clinically meaningful improvement in progression-free survival (PFS) with addition of palbociclib to anti-HER2 and endocrine therapy in patients with HR+ HER2+ metastatic breast cancer without disease progression after completing induction chemotherapy.

GS3-10 Paired DNA and RNA analysis of CALGB 40603 (Alliance) reveals insights into the molecular and prognostic landscape of stage II-III triple-negative breast cancer page 31
Lead Author: Brooke M. Felsheim, PhD
Dr. Felsheim (UNC Lineberger Comprehensive Cancer Center) shared how DNA and RNA from tumor samples collected in the CALGB 40603 trial, which investigated treatments for advanced-stage breast cancer, allowed for a deeper understanding of the molecular characteristics and potential prognostic factors within this aggressive cancer type by comparing genetic alterations with gene expression patterns at the same time.

P3-06-15 Trajectories of Daily Step Counts in Breast Cancer Survivors in the Breast Cancer Weight Loss (BWEL) Trial page 1578
Lead Author: Chao Cao, PhD, MPH
Dr. Cao (Dana-Farber Cancer Insitute) shared how daily step counts significantly increased in early breast cancer survivors who participated in telephone-based weight-loss intervention. Further follow-up will assess how changes in daily steps relate to cancer outcomes and patient-reported results.
 

P5-08-12 Association of Baseline Global Inflammation Score with Clinical Outcomes: Secondary Analysis from Alliance A011502 page 2855
Lead Author: Shipra Gandhi, MD
Dr. Gandhi (Roswell Park Comprehensive Cancer Center) shared participants with higher levels of inflammation at the start of the study had worse disease-free survival (iDFS) and overall survival (OS) in a clinical trial testing aspirin versus a placebo in breast cancer survivors at high risk. However, some of the factors contributing to inflammation might be linked to non-cancer issues (like chronic health conditions, social factors, or how well patients stick to their cancer treatments) that weren’t accounted for in this study. Also, taking aspirin didn’t affect the outcomes, no matter the level of inflammation. These findings suggest that future clinical trials should include measurements of inflammation and body mass index (BMI).

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) page 3396
Lead Author: Jennifer A. Ligibel, MD
Dr. Ligibel (Dana-Farber Cancer Institute) shared that at baseline, there were no significant differences in metabolic or inflammatory biomarkers (leptin, CRP, insulin) between the two groups: health education (HE) control group or a 2-year weight loss intervention (WLI) plus HE. However, after 6 and 24 months, the WLI group showed significant reductions in all biomarkers compared to the HE group. A telephone-based WLI significantly improved metabolic and inflammatory biomarkers linked to cancer recurrence and survival in a cohort of participants with obesity treated for breast cancer.

RF2-01 Factors Influencing Additional Nodal Disease and Pathologic Nodal Upstaging with Axillary Dissection in Patients with Residual Node-positive Breast Cancer after Neoadjuvant Chemotherapy Enrolled on Alliance A011202 Clinical Trial page 3410
Lead Author: Judy C. Boughey, MD
Dr. Boughey (Mayo Clinic) shared that in patients with residual positive lymph nodes after neoadjuvant chemotherapy (NAC), 46% had additional positive nodes found during axillary lymph node dissection (ALND). The likelihood of finding more positive nodes increased with macrometastases and the number of positive sentinel lymph nodes (SLNs). ALND also resulted in an increase in the nodal stage (ypN category) in 24.7% of patients, with a lower rate of increase in HER2+ cases. More research is needed to determine the role of ALND in treatment decisions and patient outcomes for those with positive SLNs after NAC.

RF3-06: Mepitel Film for the Reduction of Radiation Dermatitis in Post-Mastectomy Radiation Therapy: Results from Alliance A221803: A Multicenter Phase III Randomized Clinical Trial page 3431
Presenting Author: Kimberly S. Corbin, MD
Dr. Corbin (Mayo Clinic) shared results from a phase III trial that tested whether Mepitel Film (MF) could reduce radiation dermatitis (RD) in breast cancer patients receiving post-mastectomy radiation (PMRT). In the trial, 216 patients were randomly assigned to receive either MF or standard care (SoC). Data from 192 patients showed that MF significantly reduced RD severity compared to SoC, with MF patients reporting less RD (p=0.012). This benefit was consistent across all patient groups, supporting the use of Mepitel Film as a new standard of care to prevent RD in this setting.