NCT03084939

Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer

Completed Phase 3 Last updated 6 May 2023

What this trial tests

Phase 3 trial testing Trastuzumab Emtansine in Breast Cancer in 351 participants. Completed in 14 March 2023.

Timeline

24 April 2017

Primary endpoint
23 November 2018

14 March 2023

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	351
Start date	24 April 2017
Primary completion	23 November 2018
Estimated completion	14 March 2023
Sites	18 locations across China

Drugs / interventions tested

• Trastuzumab Emtansine — full drug profile →
• Lapatinib (LAPATINIB) — full drug profile →
• Capecitabine (capecitabine) — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase III, randomized, multicenter, two-arm, open-label study designed to evaluate the safety and efficacy of trastuzumab emtansine compared with that of lapatinib + capecitabine in Chinese participants with HER2-positive, unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC) who have received prior trastuzumab-based therapy. A total of approximately 350 participants will be enrolled in China. The study will consist of 2 stages. Stage 1: Eligible participants will be randomized in a 3:1 ratio to receive either trastuzumab emtansine or control (lapatinib + capecitabine). Stage 2: After Stage 1 is recruited, eligible patients will be enrolled to receive trastuzumab emtansine only.

Publications & conference data

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

1. HER2-targeted therapies in cancer: a systematic review.
   Zhu K, Yang X, Tai H, Zhong X, et al · · 2024 · cited 83× · PMID 38308374 · DOI 10.1186/s40364-024-00565-1
2. Antibody-Drug Conjugates for the Treatment of Breast Cancer.
   Corti C, Giugliano F, Nicolò E, Ascione L, et al · · 2021 · cited 51× · PMID 34207890 · DOI 10.3390/cancers13122898
3. Beyond the Paclitaxel and Vinca Alkaloids: Next Generation of Plant-Derived Microtubule-Targeting Agents with Potential Anticancer Activity.
   Zhang D, Kanakkanthara A. · · 2020 · cited 46× · PMID 32610496 · DOI 10.3390/cancers12071721
4. Clinical perspective: Antibody-drug conjugates for the treatment of HER2-positive breast cancer.
   Najminejad Z, Dehghani F, Mirzaei Y, Mer AH, et al · · 2023 · cited 45× · PMID 36950736 · DOI 10.1016/j.ymthe.2023.03.019
5. Current and future landscape of targeted therapy in HER2-positive advanced breast cancer: redrawing the lines.
   Simmons C, Rayson D, Joy AA, Henning JW, et al · · 2022 · cited 21× · PMID 35035535 · DOI 10.1177/17588359211066677
6. Advances in the study of marketed antibody-drug Conjugates (ADCs) for the treatment of breast cancer.
   Liang Y, Zhang P, Li F, Lai H, et al · · 2023 · cited 10× · PMID 38352694 · DOI 10.3389/fphar.2023.1332539
7. Primary results of ELAINA: a randomized, multicenter, open-label, phase III study of the efficacy and safety of trastuzumab emtansine <i>vs.</i> lapatinib plus capecitabine in Chinese patients with HER2-positive locally advanced or metastatic breast cancer who have received prior
   Wang X, Li W, Yin Y, Tong Z, et al · · 2023 · cited 3× · PMID 38751488 · DOI 10.21037/tbcr-23-2