NCT03140553: neoCARH

TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer

Completed Phase 2 Last updated 28 July 2020

What this trial tests

Phase 2 trial testing TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) in HER2-Positive Breast Cancer in 140 participants. Completed in 11 November 2019.

Timeline

1 September 2016

Primary endpoint
11 November 2019

11 November 2019

Quick facts

Lead sponsor	Guangdong Provincial People's Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	140
Start date	1 September 2016
Primary completion	11 November 2019
Estimated completion	11 November 2019
Sites	1 location across China

Drugs / interventions tested

• TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab)

Conditions studied

• HER2-Positive Breast Cancer — all drugs for HER2-Positive Breast Cancer →

Sponsor

Guangdong Provincial People's Hospital

Who can join

18 and older, female only, with HER2-Positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Both TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety of TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment in HER2-Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Photodynamic Therapy and Hyperthermia in Combination Treatment-Neglected Forces in the Fight against Cancer.
   Bienia A, Wiecheć-Cudak O, Murzyn AA, Krzykawska-Serda M. · · 2021 · cited 36× · PMID 34452108 · DOI 10.3390/pharmaceutics13081147
2. Anthracycline-containing <i>versus</i> carboplatin-containing neoadjuvant chemotherapy in combination with trastuzumab for HER2-positive breast cancer: the neoCARH phase II randomized clinical trial.
   Gao HF, Wu Z, Lin Y, Song XY, et al · · 2021 · cited 16× · PMID 33959195 · DOI 10.1177/17588359211009003
3. Neoadjuvant therapy with <i>vs</i>. without anthracyclines for HER2-positive breast cancer: a systematic review and meta-analysis.
   Zhu J, Min N, Chen Y, Li X. · · 2023 · cited 7× · PMID 37007556 · DOI 10.21037/atm-22-4030
4. Comparison of the efficacy and safety of the EC-T (epirubicin/cyclophosphamide followed by docetaxel) and TCb (docetaxel/carboplatin) neoadjuvant regimens in early TOP2A-normal stage II-III breast cancer.
   Li WP, Zhu T, Hu MX, Yang M, et al · · 2020 · cited 5× · PMID 32657611 · DOI 10.4149/neo_2020_200130n96
5. The optimal neoadjuvant treatment strategy for HR+/HER2 + breast cancer: a network meta-analysis.
   Liu S, Yu M, Mou E, Wang M, et al · · 2025 · cited 2× · PMID 39753653 · DOI 10.1038/s41598-024-84039-2
6. Pooled analysis of NeoCARH and NeoCART trials: patient-reported outcomes in patients with early-stage breast cancer receiving platinum-based or anthracycline-based neoadjuvant chemotherapy.
   Yang C, Li P, Chen Y, Zheng J, et al · · 2024 · cited 2× · PMID 38829506 · DOI 10.1007/s00520-024-08610-3