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

NCT05033769 | Unknown Phase 4

• 3 other identifiers: IFG-06-20192020-001938-35AGO-B-049
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer Female; Neoplasm, Breast; Breast Cancer Metastatic

Keywords

Immunoresponse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall response after three months

  three months after therapy start

• 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

• Overall survival

  From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months

• Toxicity and safety of eribulin and paclitaxel

  Therapy start until 30 days post last dose

• EORTC QLQC30

  Therapy start until therapy end after 4 cycles up to 12 weeks

Study Arms (2)

Eribulin

EXPERIMENTAL

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

Drug: Eribulin Injection [Halaven]

Paclitaxel

ACTIVE COMPARATOR

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

Drug: Paclitaxel injection

Interventions

Eribulin Injection [Halaven] DRUG

on days 1 and 8 q21d

Also known as: Eribulin

Eribulin

Paclitaxel injection DRUG

on days 1, 8, and 15 q21d

Also known as: Paclitaxel

Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut fuer Frauengesundheit: lead
• Eisai GmbH: collaborator

Study Sites (2)

Department of Gynecology, Tübingen University Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Department of Gynecology and Obstetrics, Erlangen University Hospital

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Peter A Fasching, MD, Prof.

  Department of Gynecology and Obstetrics, Erlangen University Hospital

  STUDY CHAIR

Central Study Contacts

AIRE Study manager

CONTACT

+49 (0) 9131 927 9578; aire@ifg-erlangen.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: September 5, 2021
• Study Start: March 11, 2021
• Primary Completion: July 1, 2023
• Study Completion: September 15, 2023
• Last Updated: April 18, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)