PREDIX HER2 - preoperative treatment of HER2 positive breast cancer

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: 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: EUCTR2014-000808-10-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-29
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

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

Inclusion Criteria

1.Written informed consent
2.Patients with breast cancer confirmed by histology, characterized by immunohistochemistry for ER, PR, HER2 and proliferation marker
3.Tumor and blood samples available. HER2 type confirmed by genomic profiling using Next-Generation Sequencing.
4.Age 18 years or older. Elderly patients in condition adequate for planned therapy
5.Primary breast cancer >20mm in diameter and/or verified lymph node metastases
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.Primary breast cancer as defined in p. 5 plus at most 2 morphologically characterized well-defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available.
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 40

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.Patients in child-bearing age without adequate contraception
4. 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