2026年9月17日-19日，由中国临床肿瘤学会（CSCO）和北京市希思科临床肿瘤学研究基金会共同主办的第29届CSCO学术年会在山东济南盛大开幕，本届年会以“守正规范，数智创新”为主题，秉承CSCO的一贯宗旨，本届大会汇聚了全球肿瘤领域知名专家学者，分享前沿研究成果与临床经验，将进一步推动我国乃至世界的肿瘤诊疗事业蓬勃发展！此次大会中，美国西北大学范伯格医学院William Gradishar教授做客《肿瘤瞭望》专访，围绕“双靶基石与ADC浪潮——HER2阳性乳腺癌治疗格局的演进与未来”分享了深刻见解。
编者按：2026年9月17日-19日，由中国临床肿瘤学会（CSCO）和北京市希思科临床肿瘤学研究基金会共同主办的第29届CSCO学术年会在山东济南盛大开幕，本届年会以“守正规范，数智创新”为主题，秉承CSCO的一贯宗旨，本届大会汇聚了全球肿瘤领域知名专家学者，分享前沿研究成果与临床经验，将进一步推动我国乃至世界的肿瘤诊疗事业蓬勃发展！此次大会中，美国西北大学范伯格医学院William Gradishar教授做客《肿瘤瞭望》专访，围绕“双靶基石与ADC浪潮——HER2阳性乳腺癌治疗格局的演进与未来”分享了深刻见解。
《肿瘤瞭望》：HER2阳性乳腺癌是乳腺癌精准治疗探索最成熟、迭代最快的领域，从单靶向到双靶向再到ADC时代，治疗格局在过去十余年间持续被改写。站在当前时间点，您如何看待HER2阳性乳腺癌治疗的整体现况？
William Gradishar 教授：HER2阳性乳腺癌是一种侵袭性极强的乳腺癌亚型。在曲妥珠单抗问世之前，该疾病预后极差，几乎缺乏有效治疗手段。随着HER2靶向治疗的引入，晚期患者的预后发生了根本性改变。此后，双靶向治疗（如曲妥珠单抗联合帕妥珠单抗及化疗）进一步改善了患者结局，这一策略已从晚期治疗拓展至新辅助和辅助治疗领域。
过去5至8年间，抗体偶联药物（ADC）的登场标志着又一次重大飞跃。这类药物将HER2靶向治疗与细胞毒性药物相结合，能够进一步增强早期和晚期患者的疗效。我们见证了从“曲妥珠单抗联合单药化疗”到“化疗双药联合HER2双靶”的演进，而如今ADC——无论是T-DXd单药还是与帕妥珠单抗联合——正在重塑治疗格局。每一次迭代都带来了早期与晚期疾病患者预后的双重改善。
Oncology Frontier: HER2-positive breast cancer is the most mature and fastest-evolving field of precision breast cancer therapy, with the treatment landscape continuously reshaped over the past decade — from single-target to dual-target blockade and now the ADC era. How would you characterize the current treatment landscape of HER2-positive breast cancer?
HER2-positive breast cancer is a highly aggressive subtype. Before the advent of trastuzumab, the prognosis was extremely poor, with virtually no effective treatment options. With the introduction of HER2-directed therapy, the outlook and prognosis of patients with metastatic disease changed dramatically. Subsequently, dual HER2-targeting — such as trastuzumab plus pertuzumab with chemotherapy — further improved patient outcomes, and this strategy has been extended from metastatic treatment to the neoadjuvant and adjuvant settings.
Over the past 5 to 8 years, the introduction of antibody-drug conjugates (ADCs) has marked another major leap forward. These agents combine HER2-directed therapy with cytotoxic drugs, further enhancing outcomes in both early-stage and advanced disease. We have witnessed the evolution from "trastuzumab plus a single chemotherapy agent" to "doublet chemotherapy plus dual HER2 blockade," and now ADCs — whether T-DXd monotherapy or in combination with pertuzumab — are reshaping the treatment landscape. Each iteration has delivered dual improvements in outcomes for both early-stage and advanced disease.
《肿瘤瞭望》：HP双靶联合化疗长期是HER2阳性乳腺癌的标准基石方案；而TQB2102作为同时覆盖曲妥珠单抗与帕妥珠单抗两个结合位点的双表位ADC，其新辅助单药研究已取得高于既往HP双靶联合化疗水平的缓解率，多项III期研究也正在推进。在您看来，这些研究结果将如何影响HP双靶方案在HER2阳性乳腺癌治疗中的地位？
William Gradishar 教授：若新型药物，尤其是靶向HER2不同结构域的双特异性抗体，在疗效上优于HP方案乃至T-DXd，则这些药物最终可能取代当前疗法。CLEOPATRA研究确立的化疗联合曲妥珠单抗、帕妥珠单抗方案，曾作为标准治疗超过十年，并在全球范围内被广泛应用于晚期患者，甚至拓展至新辅助早期阶段。如今，ADC药物已在晚期和早期疾病中展现出更强的疗效。以TQB2102为例，其新辅助单药研究显示8周期6.0 mg/kg方案的tpCR率高达76.9%，在HER2 3+人群中tpCR率达73.2%，这一数据在数值上优于既往ADC及标准HP联合化疗的历史报道。若这类双特异性抗体被证明疗效更优且副作用可控，它们将最终取代现有治疗，这将是HER2阳性乳腺癌治疗领域的重要进步。
Oncology Frontier: HP dual blockade plus chemotherapy has long been the cornerstone of HER2-positive breast cancer treatment. TQB2102, a bispecific ADC that covers both the trastuzumab and pertuzumab binding sites, has achieved neoadjuvant response rates exceeding those historically reported with HP dual blockade plus chemotherapy, with multiple phase III studies underway. In your view, how will these results affect the position of the HP regimen in the treatment of HER2-positive breast cancer?
If novel agents, particularly bispecific antibodies targeting different domains of HER2, prove more effective than the HP regimen or even T-DXd, these drugs may ultimately replace current therapies. The chemotherapy plus trastuzumab and pertuzumab regimen established by CLEOPATRA served as the standard of care for over a decade and was widely used globally in patients with advanced disease, and was even extended to the neoadjuvant and early-stage settings. Today, ADCs have demonstrated superior efficacy in both advanced and early-stage disease. Taking TQB2102 as an example, its neoadjuvant monotherapy study showed a tpCR rate of 76.9% with the 8-cycle 6.0 mg/kg regimen,and a tpCR rate of 73.2% in the HER2 3+ population — numerically superior to historical reports for prior ADCs and standard HP plus chemotherapy. If such bispecific antibodies prove to have superior efficacy and manageable side effects, they will ultimately replace current treatments, representing a significant advance in the field of HER2-positive breast cancer.
《肿瘤瞭望》：全球临床研究和创新药物近年来的不断涌现，给HER2阳性乳腺癌患者带来了更多的治疗选择与希望。在晚期一线治疗策略方面，CLEOPATRA研究奠定了THP方案在过去十余年的应用基础，中国自主研发的曲帕生物类似物也给患者带来了等效、可及的新选择。PATINA、HER2CLIMB-05、DESTINY-Breast09等研究相继公布了在晚期一线治疗中非常亮眼的数据结果。您如何看待这些新的治疗方式？在晚期一线治疗中，您如何为患者选择个体化的治疗方案？
William Gradishar 教授：晚期一线治疗格局正在经历变革时刻。CLEOPATRA研究确立的THP方案作为十余年基石方案，疗效确切，积累了大量临床用药经验和安全性管理措施；2024-2025年，PATINA、HER2CLIMB-05、DESTINY-Breast09等研究为晚期一线提供了新的选择，形成多种方案并存的格局。
PATINA研究采用“诱导+维持”设计，在诱导治疗后加入CDK4/6抑制剂帕博西尼，中位PFS从29.1个月延长至44.3个月，PFS改善超过15个月，成为首个在HR+/HER2+转移性乳腺癌中证实CDK4/6抑制剂临床获益的III期研究。HER2CLIMB-05研究同样采用维持治疗设计，在曲妥珠单抗+帕妥珠单抗维持基础上加入图卡替尼，中位PFS从16.3个月提升至24.9个月，疾病进展或死亡风险降低36%。DESTINY-Breast09研究则直接挑战一线标准，评估T-DXd联合帕妥珠单抗对比THP的疗效。
这些研究提示晚期一线治疗正在从固定周期向长期管理演变，强调在诱导缓解后以维持治疗延长疾病控制时间。在多种方案并存的格局下，方案选择需综合考量既往治疗史、脑转移状态、生物标志物特征、心脏毒性风险、患者偏好和药物可及性等因素，个体化制定治疗策略。
Oncology Frontier: In recent years, we have seen a rapid emergence of global clinical research and innovative drugs, which have brought more treatment options and hope to patients with HER2-positive breast cancer. In first-line treatment for advanced disease, the CLEOPATRA study established the THP regimen as the backbone of therapy for over a decade. China-developed trastuzumab, pertuzumab, and other biosimilar agents have also provided patients with new options that are equivalent and more accessible. Studies such as PATINA, HER2CLIMB-05, and DESTINY-Breast09 have since reported impressive results in the advanced first-line setting. How do you view these new treatment approaches? And in clinical practice, how do you select individualized treatment strategies for patients in the first-line advanced setting?
The first-line metastatic landscape is evolving from a single cornerstone to multiple coexisting options. The THP regimen established by CLEOPATRA has served as the cornerstone for over a decade, accumulating long-term efficacy and safety experience; in 2024-2025, studies such as PATINA, HER2CLIMB-05, and DESTINY-Breast09 have provided new options for first-line treatment, forming a landscape where multiple regimens coexist.
The PATINA study adopts an "induction + maintenance" design, adding the CDK4/6 inhibitor palbociclib after induction therapy, extending median PFS from 29.1 months to 44.3 months — a PFS improvement of more than 15 months — making it the first phase III study to demonstrate clinical benefit of a CDK4/6 inhibitor in HR+/HER2+ metastatic breast cancer. The HER2CLIMB-05 study similarly adopts a maintenance design, adding tucatinib to trastuzumab + pertuzumab maintenance, extending median PFS from 16.3 months to 24.9 months, with a 36% reduction in the risk of disease progression or death. The DESTINY-Breast09 study directly challenges the first-line standard, evaluating T-DXd plus pertuzumab versus THP.
These studies suggest that first-line treatment is evolving from fixed cycles toward long-term management, emphasizing maintenance therapy to prolong disease control after induction. In a landscape with multiple coexisting options, regimen selection requires comprehensive consideration of prior treatment history, brain metastasis status, biomarker characteristics, cardiotoxicity risk, patient preference, and drug accessibility to develop individualized treatment strategies.
William Gradishar 教授
美国西北大学范伯格医学院
美国临床肿瘤学会 (ASCO) 肿瘤培训计划委员会主席
美国国立综合癌症网络（NCCN）乳腺癌临床实践指南主席
美国西北大学Robert H. Lurie综合癌症中心血液科/肿瘤科主任
美国西北大学Maggie Daley癌症中心妇女肿瘤治疗中心主任
FDA肿瘤药物咨询委员会顾问