Clinical study with Neratinib in Metastatic breast cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 62

Inclusion Criteria

1. Patients of both sexes, over 18 years of age with locally advanced or metastatic breast cancer with hormonal receptors and HER2-negative
2. Postmenopausal or Premenopausal Women,
3. No more than one previous line of chemotherapy for locally advanced or metastatic recurrent disease.
4. Disease refractory to CDK4/6 inhibitors.
5. Subtype HER2-E according to the PAM50 analysis confirmed by the designated laboratory.
6. ECOG =1.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1. Prior treatment with any TKI directed to ERBB2 (eg, lapatinib, afatinib, dacomitinib, neratinib, tucatinib).
2. Previous treatment with a cumulative dose of epirubicin> 900 mg / m2 or a cumulative dose of doxorubicin> 450 mg / m2. If another anthracycline, or more than one anthracycline, has been used, the cumulative dose should not exceed 450 mg / m2 equivalent of doxorubicin.
3. Uncontrolled heart disease
4. Major chronic digestive disorder with diarrhea as the main symptom
5.Women of childbearing or pregnant age
6. Pleural effusion, pericardial effusion
7. Uncontrolled hypercalcemia
8. * Additional malignant neoplasm confirmed to be in progression or have needed active treatment in the last 3 years.
9. Presence of active metastases in the CNS or carcinomatous meningitis.
10. * History of pneumonitis (non-infectious) that has required steroids or active pneumonitis.
11. * Previous solid organ transplant
12. Presence of an active infection that requires systemic treatment.
13. * Known history of human immunodeficiency virus (HIV) infection.
14. * Known history of hepatitis B virus infection or known active hepatitis C virus infection
15. Inability or unwillingness to swallow tablets.
16. Known hypersensitivity to any of the components of the product under investigation, the need for combined treatment or loperamide.
17. Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4/P-gp isoform of cytochrome P450 within 5 days prior to inclusion.
18. * Presence of a psychiatric or substance abuse disorder
19. Being pregnant or breastfeeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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