Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer (AIRE)

Institute for Women's Health (IFG)

Status and phase: Enrolling; Phase 4

Conditions: Breast Cancer Female; Breast Cancer Metastatic; Neoplasm, Breast

Treatments: Drug: Paclitaxel injection; Drug: Eribulin Injection [Halaven]

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05033769

AGO-B-049 (Other Identifier)

IFG-06-2019

2020-001938-35 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

82 participants in 2 patient groups

Eribulin

Experimental group

Description:

Arm A. Eribulin 1.23 mg/m\^2, administered as an injection on day 1 and 8 q 21d for a maximum of 4 therapy cycles

Treatment:

Drug: Eribulin Injection [Halaven]

Paclitaxel

Active Comparator group

Description:

Paclitaxel 80 mg/m\^2, administered as an injection on day 1, 8 and 15 q21d for a maximum of 4 therapy cycles

Treatment:

Drug: Paclitaxel injection