Clinical Trials

JBCRG-16 (Neo-LaTH)

Investigation of Dual-HER2 Blockage Therapy in HER2-Positive Breast Cancer (exploratory randomized P-II) (JBCRG-16 NeoLaTH)

State
No longer recruiting/Ongoing trials

Objectives
To investigate the efficacy and safety of dual-HER2 blockage therapy in HER2-positive breast cancer. (1) To evaluate the efficacy and safety of trastuzumab(T) and lapatinib(L) therapy followed by combined with paclitaxel(P) in the neoadjuvant setting (2) To verify the period of T and L dual anti-HER2 therapy based on efficacy and safety (6 weeks vs 18 weeks). (3) To verify T and L combined with anti-endocrine therapy based on efficacy and safety in the patients with ER-p0sitive and HER2-positive charactersitics.

Subjects

Endpoints
Primary :pCR (including residual DCIS, breast only) Secondary: (1) Safety, (2) Clinical response rate (ORR), (3) Breast conservation rate, (4) QpCR, (5) pCR (including residual DCIS, breast + axillary), (6) SpCR

Trial Period
Registration: Feb 2012-Sep 2013
Total study period: Feb 2012-Jul 2014
Post operative follow-up: -Jul 2019 (Follow-up study)

Lead Principal Investigator
Masakazu Toi (Graduate School of Medicine Kyoto University)

Target Sample Size
200

Regimen
lapatinib+trastuzumab, weekly paclitaxel

Source of Funding
GlaxoSmithKline K.K.

Conference Presentation
Long-term follow-up of neoadjuvant dual anti-HER2 therapy with trastuzumab and lapatinib plus paclitaxel, with or without endocrine therapy for HER2‐positive primary breast cancer: Neo-LaTH (JBCRG-16) study. Analysis of tumor infiltrating lymphocytes in HER2-positive primary breast cancer treated with neoadjuvant lapatinib and trastuzumab: The NeoLath study (JBCRG-16) Duration of fasting before taking lapatinib is associated with skin toxicity in neoadjuvant treatment of HER2 positive breast cancer: A cohort study from JBCRG-16/Neo-LaTH Primary systemic therapy by dual HER2 blockage with lapatinib (La) + trastuzumab (T) for Japanese patients (pts) with HER2+ breast cancer (BC): Association of La toxicity and dose with treatment efficacy Impact of lapatinib (La) treatment duration and endocrine therapy (ET) addition on the efficacy of primary dual HER2 blockage with La and trastuzumab (T) for HER2+ breast cancer (BC) patients (pts) Dual HER2 blockage with lapatinib and trastuzumab for Japanese patients with HER2+ breast cancer

Articles and Publications
Long-Term Outcomes of a Randomized Study of Neoadjuvant Induction Dual HER2 Blockade with Trastuzumab and Lapatinib Followed by Weekly Paclitaxel Plus Dual HER2 Blockade for HER2-Positive Primary Breast Cancer (Neo-Lath Study) Efficacy and safety of trastuzumab, lapatinib, and paclitaxel neoadjuvant treatment with or without prolonged exposure to anti-HER2 therapy, and with or without hormone therapy for HER2-positive primary breast cancer: a randomised, five-arm, multicentre, open-label phase II trial

UMIN-ID
UMIN000007576

jRCT

Memo

COI Disclosure

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