New Protocol: Letrozole and Palbociclib with Trastuzumab and Pertuzumab for Neoadjuvant Triple-Positive Breast Cancer

The TOUCH trial showed that palbociclib and letrozole combined with dual anti-HER2 therapy achieved similar pCR rates to paclitaxel in HR-positive/HER2-positive early breast cancer. Both regimens were associated with manageable toxicity profiles, offering a chemotherapy-free options for triple-positive post-menopausal patients

Study

Randomized, open-label, international, multicenter, phase II study [TOUCH/IBCSG 55-17]

Post-menopausal HR-positive/HER2-positive early breast cancer with cT1c-T3, cN0 or cN1

Paclitaxel + HP (trastuzumab + pertuzumab) (n=74) vs Palbociclib + Letrozole + HP (n=73) for 16 weeks

Efficacy

pCR: 32.9% vs 33.3% (paclitaxel + HP vs. letrozole + palbociclib + HP)

Progressive disease: 4.1% vs. 2.8%

Safety

Grade >=3 AE: neutropenia (6.9% vs 43.1%), diarrhea (11% vs 8.3%).

Grade 3-4 left ventricular systolic dysfunction: 1.4% vs 2.9%.

Peripheral sensory neuropathy (4.1% vs Not reported).

Ann Oncol 20026;37:271

Malorni L, Tyekucheva S, Gombos A Palbociclib plus letrozole versus weekly paclitaxel, both in combination with trastuzumab plus pertuzumab, as neoadjuvant treatment for patients with HR-positive/HER2-positive early breast cancer: primary results from the randomized phase II TOUCH trial (IBCSG 55-17)

http://doi.org/10.1016/j.annonc.2025.10.016

Reviewed by Ulas D. Bayraktar, MD on Feb 19, 2026

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