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

• Status: Recruiting
• Trial end date: 2023-03-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut fuer Frauengesundheit
• Collaborator: Eisai GmbH
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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