Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Nod… (NCT02603679) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases
Sweden181 participantsStarted 2015-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent
✓. Female or male patients with breast cancer confirmed by histology
✓. Tumor and blood samples available. Luminal B type confirmed by immunohistochemistry or, preferably, genomic profiling using Next-Generation Sequencingwith ER ≥120% and Ki67 ≥20% and not HER2 amplified, or, if aged 40 or younger and/or verified lymph node metastases, luminal A type, defined as ER and PR positive ≥20% and the proliferation marker Ki 67 \<20% and not HER2 amplified. Any luminal B, Luminal A with verified lymph node metastases and/or aged 40 or younger
✓. Age 18 years or older. Elderly patients in condition adequate for planned therapy
✓. Primary breast cancer \>20mm in diameter and/or verified regional lymph node metastases
✓. Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders
✓. LVEF \>55%
✓. ECOG performance status 0-1
Exclusion criteria
What they're measuring
1
Radiological Objective Response Rate after Completion of the First 12-week Period of Primary Medical Treatment
Timeframe: Start of treatment until 12 weeks of treatment
. Distant metastases, including node metastases in the 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
✕. Patients in child-bearing age without adequate contraception
✕. Pregnancy or lactation
✕. Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders