bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abstract OT1-03-01: XMT-1660: A Phase 1b trial of a B7-H4 targeted Antibody Drug Conjugate (ADC) in Breast, Endometrial, and Ovarian Cancers
Authors: Hamilton Erika , Chaudhry Arvind , Spira Alexander I. , Adams Sylvia , Abuhadra Nour , Giordano Antonio , Parajuli Ritesh , Han Hyo S. , Weise Amy , Marchesani Aubri , Josephs Kate , Shin Chu Ri , Kalinsky Kevin 
Published: March 2023

Abstract
Background: Breast cancer (BC) is the most commonly diagnosed cancer and one of the leading causes of cancer death in women. Despite significant therapeutic advances, the majority of patients with unresectable or recurrent/metastatic disease eventually develop resistance to available standard of care (SOC) therapies. B7-H4 is a poor prognostic factor and is overexpressed in several cancers including endometrial, ovarian, and breast. As a member of the CD28/B7 family of cell surface proteins, it promotes tumorigenesis by suppressing anti-tumor immunity. XMT-1660 is a B7-H4-targeted Dolasynthen antibody drug conjugate with a precise, optimized drug-to-antibody ratio and a DolaLock microtubule inhibitor payload with controlled bystander effect. In the preclinical setting, XMT-1660 has demonstrated anti-tumor activity in TNBC and ER+/HER2- patient-derived xenograft mouse models, which included tumors from heavily pre-treated patients (Collins et al, AACR 2022). Increased anti-tumor activity tended to be more frequent in models with higher B7-H4 expression, providing rationale for a Ph1 clinical trial. Methods: The Ph1 trial includes a first-in-human open-label dose escalation (DES) portion followed by dose expansion (EXP) evaluating XMT-1660 in patients with BC, EC, and OC following progression on SOC as applicable (i.e., CDK4/6i + ET; platinum-based chemotherapy). In the DES, Bayesian Optimal Interval (BOIN) design will be used to determine the MTD. Patients will receive XMT-1660 IV Q3 weeks. Primary endpoints in DES are to assess safety and determine a recommended phase 2 dose (RP2D) and assessment of preliminary efficacy as a secondary endpoint. In the EXP portion, cohorts enrolling TNBC, ER+/HER2- BC, EC/OC are planned and additional patients may be enrolled based on emerging data. The primary endpoint of EXP is to assess safety and tolerability, overall response rate, disease control rate, and duration of response. Secondary endpoints include pharmacokinetic analysis and antidrug antibodies. Patients are not selected by B7-H4 status, but baseline tumors samples are collected for retrospective tumor tissue evaluation. The trial is currently enrolling patients. NCT05377996
Citation Format: Erika Hamilton, Arvind Chaudhry, Alexander I. Spira, Sylvia Adams, Nour Abuhadra, Antonio Giordano, Ritesh Parajuli, Hyo S. Han, Amy Weise, Aubri Marchesani, Kate Josephs, Chu Ri Shin, Kevin Kalinsky. XMT-1660: A Phase 1b trial of a B7-H4 targeted Antibody Drug Conjugate (ADC) in Breast, Endometrial, and Ovarian Cancers [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-03-01.
Abstract OT1-12-03: Precision breast conserving surgery with the guidance of localization combined with multidetector CT 3-dimensional image reconstruction: a single center, prospective, cohort study
Authors: Xia Yiqin , Cao Da , Yang Lili , Zheng Mingjie , Weng Miaomiao , Shi Ke , Wang Ruoxi , Zhao Meng , Xie Hui , Wang Shui 
Published: March 2023

Abstract
Introduction: Precision breast conserving surgery (PBCS) requires doctors to precisely remove the tumor while preserving as much normal tissue as possible. The aims of this study were to determine whether wire-guided localization (WGL) combined with multidetector CT (MDCT) guided 3D reconstruction could guide PBCS.
Methods: From 2020 to 2022, 31 patients with unifocal breast cancer were enrolled for PBCS guided by WGL combined with MDCT guided 3D reconstruction. Surrounded WGL was performed under local anesthesia, followed by an immediate contrast enhanced MDCT scan. PBCS guided by MDCT guided 3D reconstruction was performed one day after the localization. Women who underwent palpation guided BCS were included as control, and logistic regression analysis was applied.
Results: PBCS were performed in 31 patients. The mean tumor size in US was 19.48±5.86mm (9-32mm). Compare with control group, a smaller specimen diameter was observed in PBCS group (P=0.005), and the rate of the largest margin greater than or equal to 20mm were significantly lower (P=0.004). The operation time of PBCS was shortened (P=0.046). Moreover, PBCS does not affect the reoperation rate (P=0.514) or the rate of positive margins (P=0.660).
Conclusion: For patients with unifocal breast cancer, WGL combined with MDCT guided 3D reconstruction could guide PBCS without affecting the safety.
Table 1. Baseline characteristics of patients in PBCS group and control group. BMI, body mass index; US, ultrasound; HR, hormone receptor.
Table 2. Surgical outcomes of patients in PBCS group and control group.
Citation Format: Yiqin Xia, Da Cao, Lili Yang, Mingjie Zheng, Miaomiao Weng, Ke Shi, Ruoxi Wang, Meng Zhao, Hui Xie, Shui Wang. Precision breast conserving surgery with the guidance of localization combined with multidetector CT 3-dimensional image reconstruction: a single center, prospective, cohort study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-12-03.
Abstract OT2-08-01: A prospective phase 2 study on efficacy and safety of AK105, anlotinib combined with nab-paclitaxel (nab-P) as a first-line therapy in patients(pts) with advanced triple-negative breast cancer(TNBC)
Authors: Sun Tao , Zhang Liang 
Published: March 2023

Abstract
Background: PD-1/PD-L1 inhibitor plus chemotherapy have shown tolerability and significant clinical benefits in pts with advanced TNBC. As antiangiogenic agent could remodel tumor blood vessels and increase the response to immune-checkpoint inhibitors (ICIs), we designed an investigator initiated trial (IIT) to investigate the efficacy and safety of AK105 (anti-PD-1 antibody), anlotinib (antiangiogenic, multi-target tyrosine kinase inhibitor) combined with nab-P as a first-line therapy in pts with advanced TNBC. Method: In this multicenter, prospective, single arm, phase 2 study, eligible pts were female aged 18-75 years, with ECOG PS 0-1, who had locally advanced or recurrent/metastatic triple-negative (estrogen receptor-, progesterone receptor- and HER2-) breast cancer. The main exclusive criteria were previous use of PD-1/PD-L1 antibody, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or antiangiogenic agent, and central nervous system (CNS) metastases. Eligible pts were treated with intravenous AK105(200mg on day 1), oral anlotinib(12mg once daily on days 1-14) and intravenous nab-P (125mg/m2 on days 1 and 8). The triplet combination regimen repeated every 21 days until disease progression, death or intolerable toxicity. The primary endpoint is overall response rate (ORR), and the secondary endpoints are disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. Simon’s two-stage design were used to calculate the sample size assuming ORR is improved from 45.9% (nab-P alone) to 65% (AK105, anlotinib combined with nab-P) with the power (1-β) taken as 0.80 and the type I error (α) taken as 0.05 (two-sided). Enrollment began in June 2022 with a total goal of 42 pts at 7 sites in China. Clinical trial information: NCT05244993. Research Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Citation Format: Tao Sun, Liang Zhang. A prospective phase 2 study on efficacy and safety of AK105, anlotinib combined with nab-paclitaxel (nab-P) as a first-line therapy in patients(pts) with advanced triple-negative breast cancer(TNBC). [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT2-08-01.
Abstract OT2-18-01: Nab-paclitaxel followed by dose-dense epirubicin/cyclophosphamide in neoadjuvant chemotherapy for triple-negative breast cancer: an open-label, single-arm phase II study
Authors: Liu Yin , Fan Lei , Shao Zhi-Ming , Wang Zhong-Hua 
Published: March 2023

Abstract
Purpose: The anti-tumor activity of nab-paclitaxel followed by epirubicin/cyclophosphamide (EC) as neoadjuvant chemotherapy (NAC) in Asian patients remains unclear, particularly in the aggressive subtype triple-negative breast cancer (TNBC). This study aimed to evaluate the efficacy and safety of this NAC regimen in TNBC. Methods: In this Simon’s two-stage, phase II study, treatment-naïve patients with resectable unilateral primary invasive TNBC were enrolled. Eligible patients received nab-paclitaxel 125 mg/m2 weekly on day 1 for 12 weeks, followed by dose-dense EC (epirubicin 90 mg/m2; cyclophosphamide 600 mg/m2) on day 1 for four 2-week cycles. The primary endpoint was the total pathological complete response (tpCR, ypT0/is ypN0) rate. Secondary endpoints included breast pathological complete response (bpCR, ypT0/is) rate, objective response rate (ORR), the proportion of patients requiring breast-conserving surgery, and safety. Results: 55 eligible patients were enrolled and treated. After neoadjuvant therapy, tpCR and bpCR were respectively observed in 43.1% (95% CI, 29.3%-57.8%) and 49.0% (95% CI, 3)4.8%-63.4%) of 51 evaluable patients for pathological response evaluation. 44 had an ORR as their best response (80.0%; 95% CI, 67.0%-89.6%). No correlations between clinicopathological variables and pathological/clinical response were observed. Grade 3 or more AEs occurred in 63.6% of 55 patients. The most frequent AEs were alopecia. No treatment-related surgical delay or death occurred. Conclusions: Nab-paclitaxel followed by dose-dense EC as NAC demonstrates promising anti-tumor activity and acceptable tolerability for patients with TNBC.
Citation Format: Yin Liu, Lei Fan, Zhi-Ming Shao, Zhong-Hua Wang. Nab-paclitaxel followed by dose-dense epirubicin/cyclophosphamide in neoadjuvant chemotherapy for triple-negative breast cancer: an open-label, single-arm phase II study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT2-18-01.
Abstract P1-01-01: The Role of Adjuvant Chemotherapy for Elderly Women with Triple-Negative Breast Cancer
Authors: Lan Tian , Guo Qiusheng , Lu Yunyan , Gu Junwei , Shao Xiying , Xu Haibin , Hu Zujian 
Published: March 2023

Abstract
Purpose: There is little evidence determining whether elderly patients (from 70 to 90 years old) with triple-negative breast cancer (TNBC) could benefit from adjuvant chemotherapy (AC). The objective of this study was to explore the effect of AC in these population following surgery. Methods: A total of 4610 patients were identified in the Surveillance, Epidemiology, and End Results database (2010-2018). Inverse probability of treatment weighting (IPTW) was used to reduce the selection bias. IPTW-adjusted Kaplan-Meiers survival analysis and Cox proportional hazards models were performed to compare breast cancer specific survival (BCSS) and overall survival (OS) in the two different treatment groups. Results: All eligible patients were divided into two groups, the chemotherapy (n=1989) and the observation (n=2621) groups. The percentage of patients receiving AC versus observation increased significantly from 2010 to 2018 (estimated annual percentage change, 1.49%; 95%CI, 0.75-2.16%, p=0.002). The 5-year IPTW-adjusted rates of BCSS and OS in AC group were better than that in observation group (BCSS: 82.32% vs. 78.42%, p=0.010; OS: 75.54% vs. 64.65%, p&lt; 0.001). In IPTW-adjusted Cox proportional hazards regression analysis, elderly patients could benefit from AC (BCSS: HR, 0.77, 95%CI, 0.62-0.94, p=0.012; OS: HR, 0.66, 95%CI, 0.57-0.78, p&lt; 0.001). AC was associated with a significant outcome benefit across year at diagnosis, marital status, stage, lymph node, surgery and radiation subgroups (all p&lt; 0.05). Patients with T1ab could not benefit from AC. Conclusions: We show a BCSS and OS benefit from AC in old patients with TNBC. AC may remain a reasonable treatment approach in these specific patients. For the patients with T1ab, de-escalated treatment should be administrated with caution. It requires further randomized controlled trial to ensure the AC effectiveness for elderly TNBC patients.
Citation Format: Tian Lan, Qiusheng Guo, Yunyan Lu, Junwei Gu, Xiying Shao, Haibin Xu, Zujian Hu. The Role of Adjuvant Chemotherapy for Elderly Women with Triple-Negative Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-01-01.
Abstract P1-03-03: Real-World Treatment Patterns and Clinical Outcomes in Patients Treated with Eribulin After Prior PI3K Inhibitor Therapy for Metastatic Breast Cancer
Authors: Goyal Ravi K. , Zhang Jingchuan , Davis Keith L. , Kaufman Peter A. 
Published: March 2023

Abstract
Background: Eribulin has been used in the treatment of metastatic breast cancer (MBC) following approval in 2010 in the United States (US). Recently, several new therapeutic classes have been approved for patients with MBC, including the phosphoinositide 3-kinase (PI3K) inhibitor alpelisib. This study aimed to assess the treatment patterns and clinical outcomes in patients with MBC treated with eribulin following alpelisib in US clinical practice. Methods: A retrospective, noninterventional medical chart review study was performed to obtain de-identified patient data via participating oncologists. Study population included adult female patients with a diagnosis of MBC who initiated eribulin therapy between March 1, 2019, and September 30, 2020, following prior therapy with alpelisib. Eribulin treatment parameters and patient characteristics were captured. Progression-free survival (PFS) and overall survival (OS) since eribulin initiation was assessed using Kaplan-Meier methods. Results: This interim analysis included 47 eligible patients (median age 62 years at eribulin initiation; 77% Caucasian). The majority (91.5%) of this cohort had HR+/HER2– MBC; 72.3% had a known PIK3CA mutation. Eribulin was classified as 2nd line, 3rd line, and 4th line or later in 34%, 47%, and 19% of patients, respectively, in regard to the line of therapy in the metastatic setting. At last follow-up, eribulin treatment was ongoing for 34% of patients. The median treatment duration was 5.2 months (q1, q3: 3.9, 7.1) among those who had discontinued eribulin, and 11.3 months (q1, q3: 10.0, 13.7) among those who were still on treatment. At last follow-up, 72.3% of patients were alive. The estimated PFS rate at 12 months was 57.1% (95% CI: 40.0-70.9). Median was not reached for OS after initiation of eribulin; the estimated OS rates at 12 and 24 months were 80.2% (95% CI: 65.3-89.2) and 61.8% (95% CI: 37.2-79.2), respectively. Conclusion: Among patients with MBC who initiated eribulin following prior treatment with a PI3K inhibitor, over 60% were estimated to survive for at least 2 years. Future studies to confirm these results are warranted.
Citation Format: Ravi K. Goyal, Jingchuan Zhang, Keith L. Davis, Peter A. Kaufman. Real-World Treatment Patterns and Clinical Outcomes in Patients Treated with Eribulin After Prior PI3K Inhibitor Therapy for Metastatic Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-03-03.
Abstract P1-09-02: Oncological, Cosmetic and Quality of life outcomes following breast conservation surgery in patients presenting after non-oncological excsion of breast primary: A prospective follow up study
Authors: IRRINKI R N NAGA SANTOSH , KHARE SIDDHANT , Singh gurpreet , laroiya ishita , mishra aniket 
Published: March 2023

Abstract
Background For early-stage breast cancer BCS followed by radiation therapy has been validated as safe alternative to Radical Mastectomy. One peculiar problem faced in developing countries is patients in whom primary tumor has been excised elsewhere. There is a lack of clear treatment history and pre-operative examination and imaging in such patients, which makes accurate staging and planning for definitive surgery much more challenging. We did this retrospective analysis to assess clinical, cosmetic and QOL outcomes in the above-mentioned group of patients. Methods Patients between 18 and 80 years diagnosed with biopsy proven carcinoma breast that had the primary tumor excised outside and underwent BCS at our institute were included. They were subjected to routine history and physical examination as per the institute standard of care. Overall survival was estimated using Kaplan Meier curve. Expected 4 years survival was calculated using percentage of people who were alive out of those patients whose follow up was known at the end of 4 years. Cosmetic outcome was assessed using patient reported BCTOS 12 scores whereas quality of life outcome was assessed using patient reported EORTC and SF 36 questionnaire scores. Results Twenty-two patients were enrolled. Overall survival at 4 years was 72% comparable in NACT and No NACT (p&lt; 0.29). 5.45% patients had local recurrence. Cosmetic outcome was excellent to good in 90% patients, similar between NACT and No NACT (p 0.69). Quality of life was excellent-good in 65% patients (EORTC) which was significantly higher in No NACT group (p 0.05) Conclusion BCS after scar excision following non oncological resection of breast primary may be an acceptable modality of treatment with good cosmetic and Quality of life outcomes.
Citation Format: R N NAGA SANTOSH IRRINKI, SIDDHANT KHARE, gurpreet Singh, ishita laroiya, aniket mishra. Oncological, Cosmetic and Quality of life outcomes following breast conservation surgery in patients presenting after non-oncological excsion of breast primary: A prospective follow up study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-09-02.
Abstract P1-09-11: Impact of breast surgical procedure on survival in BRCA mutated patients with invasive breast cancer: mastectomy versus conservative treatment
Authors: JANKOWSKI CLEMENTINE , Mahiou Katia , Laura Vincent , Costaz Hélène , padéano Marie-Martine , Causeret Sylvain , Mamguem Ariane , Dabakuyo Sandrine , COUTANT CHARLES 
Published: March 2023

Abstract
Introduction: Patients with BRCA1/2 mutations have a higher risk of developing breast cancer compared to the wild-type population. For patients with a BRCA mutation, there are no specific recommendations for surgical management. The aim of this study was therefore to retrospectively investigate overall survival (OS) and recurrence-free survival (RFS) of BRCA mutated patients with localized invasive breast cancer, by comparing conservative surgery versus mastectomy. Methods: This study was based on data from the Côte d’Or breast and gynecological cancer registry. Data from patients with a constitutional BRCA1/2 mutation who presented with invasive breast cancer were collected retrospectively from 1998 to 2018. The Kaplan-Meier method was used to describe RFS and OS. Results:A total of 104 patients were included in the analysis, of whom 69 had conservative surgery and 35 underwent mastectomy. Regarding survival, there was no significant difference in OS (HR =1.49; 95% confidence interval (CI) [0.76-2.93], p=0.25). Similarly, there was no significant difference in RFS (HR =1.40; 95% CI [0.81-2.40], p=0.22), survival without homolateral recurrence (HR =0.88; 95% CI [0.30-2.61], p=0.89), without contralateral recurrence (HR =1.50; 95% CI [0.55-4.09], p=0.42), or without distant metastatic recurrence (HR =1.42, 95% CI [0.69-2.90], p=0.33). Conclusion: In invasive breast cancer in a patient with a germline BRCA1/2 mutation, conservative surgery, when possible, appears to be a feasible option over total mastectomy, with no difference in overall survival. However, the patient should be informed of the aggressive nature of recurrence in this population requiring chemotherapy in most cases.
Citation Format: CLEMENTINE JANKOWSKI, Katia Mahiou, Vincent Laura, Hélène Costaz, Marie-Martine padéano, Sylvain Causeret, Ariane Mamguem, Sandrine Dabakuyo, CHARLES COUTANT. Impact of breast surgical procedure on survival in BRCA mutated patients with invasive breast cancer: mastectomy versus conservative treatment [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-09-11.
Abstract P1-10-03: Ultra-hypofractionated Radiotherapy for Breast Cancer: A Brazilian Single-Institutional Series
Authors: de Brito Leticia Hernandes , Restini Felipe Cicci Farinha , Starling Maria Thereza Mansur , de Siqueira Gabriela Silva Moreira , Marta Gustavo Nader , Carvalho Heloisa de Andrade , Hanna Samir Abdallah 
Published: March 2023

Abstract
INTRODUCTION Extreme hypofractionation in patients with early-stage breast cancer has been studied in randomized phase III non-inferiority trials. There is scarce data on this strategy in Latin American patients. OBJECTIVES To describe the profile of patients diagnosed with breast cancer treated with radiotherapy with an ultra-hypofractionated regimen (5 fractions of 5.2 Gy, in one week), as well as the dosimetric aspects and acute toxicity related to the treatment. METHOD Retrospective cohort through a Brazilian uni-institutional series, with analysis of pathological, dosimetric, and toxicity variables. RESULTS Between May 2020 and March 2022, 67 patients were included, with a median age at diagnosis of 71 years (41-93). Regarding staging, 25.8% had in situ tumors, 60.6% of patients were IA, and only 3% were stage IIA. Nineteen percent of patients had histological grade 3; 24.6%, had nuclear grade 3. Hormone receptors were positive in 92.1% of patients. The mean ki67 was 19%, and HER2 was negative at 84.5%. All patients underwent conservative surgery, and 5 underwent reconstruction with autologous flaps. Fifty-one patients underwent hormone therapy and only 2 underwent adjuvant chemotherapy. All but two patients were treated with the conformal technique (VMAT was used due to unfavorable anatomy). The mean volume of the irradiated breast was 926 cm3 (ranging from 920 to 932 cm3). Regarding the constraints of the organs at risk, the average V8Gy of the ipsilateral lung was 11.4%, ranging from 0 to 24%. In the heart, the average volumes receiving 1.5Gy and 7Gy were, respectively, 9.2% and 0.7%. No patient had acute toxicity greater than grade 2. The effects on the skin appeared on average 20 days after the end of treatment, with resolution in a maximum of 3 months. The median follow-up time was 10 months (3 - 26). We did not observe any case of local-recurrence, of breast-cancer-related death. CONCLUSION Although our follow-up time is premature, we have found that ultra-hypofractionated radiotherapy was feasible, tolerable, and safe, for patients with early breast cancer. Also, the constraints on the organs at risk were respected. There were no high-grade acute toxicities. Besides convenience, ultra-hypofractionation can improve access to radiotherapy in resource-scarce settings.
Citation Format: Leticia Hernandes de Brito, Felipe Cicci Farinha Restini, Maria Thereza Mansur Starling, Gabriela Silva Moreira de Siqueira, Gustavo Nader Marta, Heloisa de Andrade Carvalho, Samir Abdallah Hanna. Ultra-hypofractionated Radiotherapy for Breast Cancer: A Brazilian Single-Institutional Series [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-10-03.