PMID- 33959195 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220422 IS - 1758-8340 (Print) IS - 1758-8359 (Electronic) IS - 1758-8340 (Linking) VI - 13 DP - 2021 TI - Anthracycline-containing versus carboplatin-containing neoadjuvant chemotherapy in combination with trastuzumab for HER2-positive breast cancer: the neoCARH phase II randomized clinical trial. PG - 17588359211009003 LID - 10.1177/17588359211009003 [doi] LID - 17588359211009003 AB - BACKGROUND: Although dual blockade HER2-based neoadjuvant chemotherapy is associated with excellent outcomes for human epidermal growth factor receptor 2 (HER2)-positive breast cancer, pertuzumab is not available to all patients due to cost. The optimal neoadjuvant chemotherapy for HER2-positive breast cancer in the presence of a single HER2 blockade is unknown. This study aimed to compare the efficacy and safety of epirubicin/cyclophosphamide followed by docetaxel/trastuzumab (EC-TH) with docetaxel/carboplatin/trastuzumab (TCH) neoadjuvant setting for HER2-positive breast cancer under the single HER2 blockade. METHODS: Patients with stage II-IIIC HER2-positive breast cancer were randomly assigned to either eight cycles of EC-TH every 3 weeks during all chemotherapy cycles, or six cycles of TCH every 3 weeks. The primary endpoint was pathological complete response (pCR) (defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0). RESULTS: From May 2017 to November 2019, 140 patients were randomly assigned, and 135 patients were ultimately found evaluable for the primary endpoint. The pCR was recorded in 25 of 67 patients [37.3%; 95% confidence interval (CI), 25.8-50.0] in the EC-TH group and in 38 of 68 patients (55.9%, 95% CI, 43.3-67.9) in the TCH group (p = 0.032). The most common adverse events (AEs) were neutropenia in 24 of 67 (35.8%) patients in the EC-TH group versus 27 of 68 (39.7%) in the TCH group (p = 0.642), anemia in 33 of 67 (49.3%) patients in the EC-TH group versus 34 of 68 (50.0%) in the TCH group (p = 0.931), and thrombocytopenia in five of 67 (7.5%) patients in the EC-TH group versus 17 of 68 (25.0%) in the TCH group (p = 0.006). CONCLUSION: For patients receiving the single HER2 blockade trastuzumab for HER2-positive breast cancer, TCH regimen might be a preferred neoadjuvant therapy. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov identifier: NCT03140553) on 2 May 2017. CI - (c) The Author(s), 2021. FAU - Gao, Hong-Fei AU - Gao HF AD - Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. FAU - Wu, Zhiyong AU - Wu Z AD - Diagnosis & Treatment Center of Breast Diseases, Shantou Central Hospital, Shantou, Guangdong, China. FAU - Lin, Ying AU - Lin Y AD - Breast Disease Center, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China. FAU - Song, Xiang-Yang AU - Song XY AD - Breast Center, Sir Run Run Shaw Hospital, Medical College of Zhejiang University, China. FAU - Cao, Yin AU - Cao Y AD - Breast Central, Dongguan People's Hospital, Dongguan, Guangdong, China. FAU - Chen, Qian-Jun AU - Chen QJ AD - Breast Central, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China. FAU - Zhang, Gangling AU - Zhang G AD - Breast Surgery, Baotou Cancer Hospital, China. FAU - Fu, Peifen AU - Fu P AD - Breast Surgery, 1st Affiliated Hospital, School of Medical, Zhejiang University, China. FAU - Liu, Zhenzhen AU - Liu Z AD - Department of Breast Cancer Center, Affiliated Tumor Hospital of Zhengzhou University: Henan Cancer Hospital, Zhengzhou, Henan, China. FAU - Zhang, Liu-Lu AU - Zhang LL AD - Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. FAU - Yang, Ci-Qiu AU - Yang CQ AD - Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. FAU - Yang, Mei AU - Yang M AD - Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. FAU - Zhu, Teng AU - Zhu T AD - Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. FAU - Ji, Fei AU - Ji F AD - Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. FAU - Li, Jie-Qing AU - Li JQ AD - Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. FAU - Cheng, Min-Yi AU - Cheng MY AD - Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. FAU - Wang, Kun AU - Wang K AUID- ORCID: 0000-0001-9851-7080 AD - Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, No.123 Huifu West, Yuexiu District, Guangzhou, Guangdong 510080, China. LA - eng SI - ClinicalTrials.gov/NCT03140553 PT - Journal Article DEP - 20210420 PL - England TA - Ther Adv Med Oncol JT - Therapeutic advances in medical oncology JID - 101510808 PMC - PMC8064510 OTO - NOTNLM OT - breast cancer OT - human epidermal growth factor receptor 2 OT - neoadjuvant treatment OT - trastuzumab COIS- Conflict of interest statement: The authors declare that there is no conflict of interest. EDAT- 2021/05/08 06:00 MHDA- 2021/05/08 06:01 PMCR- 2021/04/20 CRDT- 2021/05/07 07:11 PHST- 2021/01/13 00:00 [received] PHST- 2021/03/22 00:00 [accepted] PHST- 2021/05/07 07:11 [entrez] PHST- 2021/05/08 06:00 [pubmed] PHST- 2021/05/08 06:01 [medline] PHST- 2021/04/20 00:00 [pmc-release] AID - 10.1177_17588359211009003 [pii] AID - 10.1177/17588359211009003 [doi] PST - epublish SO - Ther Adv Med Oncol. 2021 Apr 20;13:17588359211009003. doi: 10.1177/17588359211009003. eCollection 2021.