Second line ERIbulin followed by CApecitabine or the reverse sequence in HER2-negative Metastatic Breast Cancer (MBC) patients: a randomized phase II study – ERICA trial

Phase 1

• Conditions: HER2-negative Metastatic Breast Cancer; MedDRA version: 20.0Level: PTClassification code 10073100Term: Metaplastic breast carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004652-35-IT
• Lead Sponsor: CONSORZIO ONCOTECH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1.Written informed consent (both for clinical and blood biomarker study);
2.Histological diagnosis of HER2 negative MBC;
3.Females >= 18;
4.Measurable disease (according RECIST criteria version 1.1)
5.Prior Anthracyclines and Taxanes
6. 1 prior cytotoxic regimen for advanced or MBC (not including adjuvant or neo-adjuvant therapy). Patients with no prior cytotoxic regimens for advanced or metastatic disease will only be allowed if they relapsed during or within 6 months of (neo-) adjuvant cytotoxic therapy that included anathracyclines and taxanes;
7.Prior hormonotherapy and Cyclines inhibitors are allowed, so as indicated in the international guidelines for the management of hormone positive breast cancer (ER and/or PR positive);
8.ECOG Performance Status <= 2
9.Absence of angina or heart failure or infarction within 12 months from inclusion;
10.Adequate bone marrow and organ function as follows (haemoglobin >= 9.0 g/dl; absolute neutrophil count >= 1.5x103/mm3; plateled count >= 100x103/mm3; bilirubin levels <= 1.5 times Upper Limits of Normal - biliary stenting is allowed to resolve obstruction – Serum Transaminase level <= 2.5 times ULN; serum creatinine <= 1.5 times ULN
11.Life expectancy of at least 12 weeks
12.If women of childbearing potential age: effective contraceptive measures must be used during the study treatment period and up to 3 months after the last dose of study drug.
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 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1.Unability to give informed consent;
2.Absence of measurable disease;
3.Concurrent active malignancies (except of in situ carcinoma of the cervix and inactive non-melanoma skin cancer);
4.Current active infection;
5.Serious pre-existing medical conditions or serious concomitant diseases;
6.Systemic disorders that would compromise the safety of the patient or her ability to complete the study, at the discretion of the investigator (for example, unstable angina pectoris, or a clinically significant history of cardiac disease or uncontrolled diabetes mellitus);
7.Known immunodeficiency virus infection;
8.Pregnant or breastfeeding women;
9.Unable to undergo medical test for geographical, social or psychological reason
10.Active or symptomatic brain metastases.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified