Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors (PREDIX LumA)
Early-Stage Breast Carcinoma, Hormone Receptor Positive Tumor
About this trial
This is an interventional treatment trial for Early-Stage Breast Carcinoma focused on measuring Neoadjuvant Therapy, Cyclin-Dependent Kinase Inhibitor p16
Eligibility Criteria
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
- Age ≤40 years
- Lobular carcinoma
- Patients in child-bearing age without adequate contraception
- Pregnancy or lactation
- Severe medical or psychiatric disorders where the study treatment or study procedures carry increased risk of deterioration of health status
Sites / Locations
- Department of Oncology, Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
A: Endocrine treatment
B: Endocrine treatment + palbociclib
C: Endocrine treatment + palbociclib
Pre- or perimenopausal women are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women); postmenopausal women receive an aromatase inhibitor. The preoperative treatment is continued for further 12 weeks, provided that re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option
Patients receive the same endocrine treatment as in arm A together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period. The combined treatment is continued for further 12 weeks, provided that re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option
Patients receive the same endocrine treatment as in arm A together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period. The combined treatment is continued for further 12 weeks, if re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option