Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer

Breast Cancer Female Clinical Trial

— AIRE  

Official title:

AIRE - Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer - a Prospectively Randomized Phase IV Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05033769
• Other study ID #: IFG-06-2019
• Secondary ID: 2020-001938-35AG
• Status: Recruiting
• Phase: Phase 4
• Start date: March 11, 2021
• Est. completion date: September 15, 2023

Study information

• Verified date: June 2022
• Source: Institut fuer Frauengesundheit
• Contact: AIRE Study manager
• Phone: +49 (0) 9131 927 9578
• Email: aire[@]ifg-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After progression of disease after one chemotherapy, metastatic breast cancer patients will be randomized 1:1 to one of the following treatment arms: Arm A. Eribulin Arm B. Paclitaxel Blood draws for immune analysis will be performed before start of therapy, on day 1 of cycle 2 and on day 21 of cycle 4 (end of therapy) for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.

Description:

This is a prospective, randomized Phase IV study. Patients who progressed after one chemotherapy in the metastatic setting will be randomized 1:1 to one of the following treatment arms. Arm A. Eribulin 1.23 mg/m2 on days 1 and 8 q21d Arm B. Paclitaxel 80 mg/m2 on days 1, 8, and 15 q21d Blood draws for immune analysis will be performed before start of therapy on day 1 of cycle 1, on day 1 of cycle 2 (pre dose each) and on day 21 of cycle 4 (end of therapy) and assessed for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: September 15, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent prior to beginning of trial specific procedures
• Subject must be female and aged = 18 years on day of signing informed consent
• ECOG 0-1
• Histologically confirmed, HER2 negative breast cancer determined by core biopsy of tumor lesion. Human epidermal growth factor receptor 2 (HER2) negativity is defined as either of the following by local laboratory assessment: In situ hybridization (ISH) non-amplified (ratio = 2.2), or IHC 0 or IHC 1+.
• Indication for chemotherapy
• Previous therapy with one chemotherapy line
• Target lesion (RECIST 1.1)
• Adequate organ function defined as:

Creatinine Clearance > 50 ml/min ANC = 1.5 x 10 3 /µL Thrombocytes > 100 x 10 3 /µL

Exclusion Criteria:

• HER2 positive disease
• Indication for an anti-hormone treatment
• Active infection requiring systemic therapy.
• Active autoimmune disease or other diseases that requires systemic treatment with corticosteroids or immunosuppressive drugs.
• History of primary or acquired immunodeficiency (including allogenic organ transplant).
• Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
• Severely impaired liver function (Child Pugh C)
• Hypersensitivity to study medication or any of its components
• Neuropathy (PNP) > Grade 2 (CTCAE 5.0)
• Congenital long QT syndrome
• Preexisting concomitant use of strong CYP3A4 and CYP2C8 inhibiting or inducing drugs
• Life expectancy of less than three months
• Pregnancy (contraception is required according tocontraceptive guidance)
• Lactation
• Known history of following infections: Human immunodeficiency virus (HIV), History of acute or chronic Hepatitis B or Hepatitis C
• Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
• Does not agree to blood collection

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Cancer Metastatic
• Breast Neoplasms
• Neoplasm, Breast

Intervention

Drug:
• Eribulin Injection [Halaven]
on days 1 and 8 q21d
• Paclitaxel injection
on days 1, 8, and 15 q21d

Locations

Country	Name	City	State
Germany	Department of Gynecology and Obstetrics, Erlangen University Hospital	Erlangen	Bavaria
Germany	Department of Gynecology, Tübingen University Hospital	Tübingen	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Institut fuer Frauengesundheit	Eisai GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune responsivity (IR)	defined as = 5% of all T cells from peripheral blood are Ki-67 positive after chemotherapy	12 weeks after therapy start
Secondary	Overall response after three months	Overall response	three months after therapy start
Secondary	Progression free survival	Progression free survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary	Overall survival	Overall survival	From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months
Secondary	Toxicity and safety of eribulin and paclitaxel	Toxicity and safety of eribulin and paclitaxel	Therapy start until 30 days post last dose
Secondary	EORTC QLQC30	Quality of life assessed via EORTC QLQC30	Therapy start until therapy end after 4 cycles up to 12 weeks