Primary breast cancer MedDRA version: 20.0 Level: PT Classification code 10006200 Term: Breast cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10006201 Term: Breast cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10006191 Term: Breast cancer male NOS System O
Conditions
Interventions
Product Name: palbociclib
Pharmaceutical Form: Tablet
INN or Proposed INN: Palbociclib
CAS Number: 827022-33-3
Current Sponsor code: PD-0332991
Other descriptive name: PALBOCICLIB
Concentration unit:
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Female or male patients with breast cancer confirmed by histology 3. Tumor and blood samples available. Luminal type confirmed by immunohistochemistry with ER =10 %, not HER2 3+/amplified 4. Age 35 years or older. Elderly patients in condition adequate for planned therapy 5. Primary breast cancer >20mm in diameter and/or high proliferation and/or malignancy grade II or III and/or regional lymph node metastases including ipsilateral supraclavicular nodes with breast cancer diagnosis confirmed by histological examination with or without breast tumor lesions 6. Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders 7. LVEF >55% 8. ECOG performance status 0-1 9. Patients in child-bearing age with adequate contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1. Distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum 2. 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 3. Pregnancy or lactation 4. Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the impact of neoadjuvant endocrine treatment with palbociclib compared with standard chemotherapy on objective response and long-term outcome.;Secondary Objective: Identify tumor characteristics and treatment-related changes of tumor biology predictive of long-term prognosis;Primary end point(s): Pathological objective response to primary medical treatment;Timepoint(s) of evaluation of this end point: Three months after surgery, End-of-Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical/radiological objective response during neoadjuvant treatment. Morphological, functional and biological characteristics of tumors exposed to cytotoxic and targeted treatment of early breast cancer. Event-free survival (EFS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS), breast cancer-specific survival (BCSS) and overall survival (OS). Safety Quality of life Frequency of breast-conserving surgery ;Timepoint(s) of evaluation of this end point: At End-of-Treatment and annual follow-up visits during 5 years. Survival and adjuvant treatment will be followed up to ten years. | — |
Countries
Sweden
Contacts
Public ContactBreast-sarcoma unit
Dept. of Oncology, Karolinska University Hospital
Outcome results
None listed