PREDIX Luminal B - preoperative treatment of patients with fast growing hormone receptor positive breast cancer or those with slowly growing tumors with lymphnode metastasis or young age
- Conditions
- Primary breast cancerMedDRA version: 20.0Level: PTClassification code 10006200Term: Breast cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10006191Term: Breast cancer male NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10006188Term: Breast cancer female NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-000810-72-SE
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Clinical/radiological objective response during neoadjuvant treatment<br>Morphological, functional and biological characteristics of tumors exposed to cytotoxic and targeted treatment of early breast cancer <br>Disease-free, breast cancer-specific and overall survival<br>Safety<br>Quality of life<br>Frequency of breast-conserving surgery<br>;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.