Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases

Summary

The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of chemotherapy using weekly paclitaxel (arm A) versus the combination of the cdk 4/6 inhibitor palbociclib and standard endocrine treatment (arm B). After 12 weeks treatment is switched crossover. During the 24-weekly treatment period, clinical and radiological evaluations are performed repeatedly. Switch between the treatment arms A and B is allowed in case of lack of response or due to toxicity. A translational subprotocol is a mandatory part of the study protocol, except for use of PET-CT evaluations. Postoperatively, patients receive three 3-weekly courses of chemotherapy with a combination of epirubicin and cyclophosphamide.

Timeline

Start

2015-02

Primary completion

2021-07-30

Completion

2031-12-31

Outcome

Missed primary endpoint

paper There is no statistically significant difference between the two arms in ORR12 (59% vs 45%, p = 0.058). PMID 41951647 ↗

Publications

• Matikas A, Tzoras E, Sarafidis M, Sifakis EG, Bjohle J, Barnekow E, Margolin S, Isaksson-Friman E, Kessler LE, Zouzos A, Johansson H, Hellstrom M, Agartz S, Gryback P, Salgkamis D, Zerdes I, Wang K, Hartman J, Acs B, Sun W, Boyaci C, Villacampa G, Pascual T, Gavila J, Prat A, Perou C, Brandberg Y, Bergh J, Hatschek T, Foukakis T. Neoadjuvant palbociclib and endocrine therapy versus chemotherapy in ER + /HER2- breast cancer: a randomized phase II trial. Nat Commun. 2026 Apr 8;17(1):3403. doi: 10.1038/s41467-026-71452-6.

Drugs

Indications