Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors
Sweden10 participantsStarted 2015-10
Plain-language summary
The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6 inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive endocrine treatment for 4 weeks. In case of decrease of proliferation (Ki67) patients are then randomized between either continuous endocrine therapy (arm A) or the same treatment with addition of palbociclib (arm B). Patients with no change of proliferation are allocated to endocrine treatment + palbociclib without randomization (arm C). During the 12-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.
Who can participate
Age range41 Years
SexFEMALE
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Inclusion criteria
✓. Written informed consent
✓. Female patients with non-lobular breast cancer confirmed by histology
✓. Tumor and blood samples available. Luminal A type confirmed by immunohistochemistry with ER and PR positive ≥50% and the proliferation marker Ki 67 \<20% and not HER2 amplified
✓. Age older than 40 years
✓. Primary breast cancer \>20mm without lymph node metastases
✓. Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders
✓. LVEF \>50%
✓. ECOG performance status 0-1
Exclusion criteria
✕. Metastases, including node metastases in the ipsilateral and/or contralateral thoracic region or in the mediastinum
✕. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix
What they're measuring
1
Clinical and Radiological Response
Timeframe: After 16 weeks of preoperative treatment