Breast Cancer Female, Breast Cancer Metastatic, Neoplasm, Breast
Conditions
Keywords
Immunoresponse
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.
Detailed 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.
Interventions
DRUGEribulin Injection [Halaven]
on days 1 and 8 q21d
DRUGPaclitaxel injection
on days 1, 8, and 15 q21d
Sponsors
Eisai GmbH
Institut fuer Frauengesundheit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune responsivity (IR) | 12 weeks after therapy start | defined as ≥ 5% of all T cells from peripheral blood are Ki-67 positive after chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response after three months | three months after therapy start | Overall response |
| 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 | Progression free survival |
| Overall survival | From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months | Overall survival |
| Toxicity and safety of eribulin and paclitaxel | Therapy start until 30 days post last dose | Toxicity and safety of eribulin and paclitaxel |
| EORTC QLQC30 | Therapy start until therapy end after 4 cycles up to 12 weeks | Quality of life assessed via EORTC QLQC30 |
Countries
Germany
Contacts
Primary ContactAIRE Study manager
Outcome results
None listed