PREDIX Luminal A - preoperative treatment of slowly growing hormone receptor positive breast cancer in patients older than 35 years without lymph node metastases

Phase 1

• Conditions: Primary breast cancer; MedDRA 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: 20.0Level: LLTClassification code 10006191Term: Breast cancer male NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: 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: EUCTR2014-000809-12-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-04
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1.Written informed consent
2.Female patients with non-lobular breast cancer confirmed by histology
3.Tumor and blood samples available. Luminal subtype confirmed by genomic profiling using Next-Generation Sequencing.
4.Age older than 35 years. Elderly patients in condition adequate for planned therapy
5. Primary breast cancer >20mm without palpable axillary lymph node metastases. Occult node metastases, detected by either ultrasound of the axilla or sentinel-node biopsy (SNB) performed before start of neoadjuvant treatment can be included
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

1. Male breast cancer
2. Lobular cancer
3. Distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum
4. 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
5. Pregnancy or lactation
6. 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 or without palbociclib 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: At End-of Treatment visit 3 months after surgery

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: After surgery (End-of-treatment 3 months after surgery) and annual follow-up visits during 10 years