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

Condition(s) studied

Investigational drug(s) / intervention(s)

Paclitaxel: Any brand of paclitaxel may be used, excluding nab-paclitaxel

Tamoxifen + Palbociclib: Any brand of tamoxifen may be used

Aromatase Inhibitor + Palbociclib: Any brand of letrozole, anastrozole or exemestane may be used

Goserelin + Aromatase Inhibitor + Palbociclib: Any brand of letrozole, anastrozole or exemestane may be used

Study 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.

Eligibility

Primary outcome measure(s)

• Radiological Objective Response Rate after Completion of the First 12-week Period of Primary Medical Treatment — Start of treatment until 12 weeks of treatment
  Radiological response by use of mammography and ultrasound, alternatively MRI of the breast, if mammography/ultrasound does not allow for objective measurements of the primary tumor. Clinical measurements using calliper, if the tumor is palpable and tumor size cannot be estimated by radiological methods

Trial sites (3)

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