primary breast cancer
Conditions
Interventions
Product Name: L-BLP25 (Stimuvax®)
Product Code: EMD531444
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: L-BLP25 reconstituted
Other descriptive name: L-BLP25 reconstitu
Sponsors
ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Pre- and postmenopausal female patients with core-biopsied, early primary invasive breast cancer of any clinical and/or radiological tumor stage (except T4d, inflammatory breast cancer) scheduled to receive pre-operative therapy. • One core from the biopsy will be dedicated to analyses of a validated gene expression array • Patients must fulfill the following criteria: -Postmenopausal AND E+++ or [E++ and ki6714%] OR G3 OR premenopausal status AND scheduled for anthracyclin-taxan-based chemotherapy as institutional standard of care (34 B) *Note: for ki67 status determination any antibody can be used; scores for determination of E/PR receptor status according to institutional standard • No distant metastasis (M0) or secondary carcinoma as assessed clinically and radiologically (X-Ray or CT or MRI or PET) within 3 months prior randomization • Age = 18 • WHO performance status 0 or 1 • No prior chemotherapy, radiotherapy, or endocrine therapy for invasive breast cancer • Willingness to undergo Sln and/or ALND Procedure (Sentinel/Axillary Lymph node dissection) acc. to institutional standard • No medical and/or cardiologic contraindication to receive an anthracyclin- and taxan-containing chemotherapy or endocrine therapy regimen • Adequate Hematologic function (= 14 days prior to randomization) • Adequate Renal function (= 14 days of randomization) • Adequate Hepatic function (= 14 days of randomization) • Adequate cardiac function: Normal cardiac function must be confirmed by LVEF (Echocardiography or MUGA scan) for chemotherapy treatment only. The result must be above 50% or above the lower normal limit of the institution. In addition each of the following criteria must be met: o NYHA 12 months with uterus still in situ and/or c) the patient is 61 years of age or older.In this situation, the investigator must document why the pregnancy test was not performed. • In all premenopausal patients adequate conception with non-hormonal methods (e.g. condoms, non-levonorgestrel-releasing intrauterine devices, diaphragms, vasectomized partner, or abstinence) is mandatory during study duration until at least 30 days after the last vaccination of L-BLP25. • Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form and able to comply with the required treatments, visits and assessments • Informed consent signed prior to randomization and prior to any study specific procedure (study specific baseline blood sample) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: • HER2 overexpression (+++) • Past or current history of other neoplasms in the last 5 years, except basal cell cancer of the skin, non-melanoma skin cancer and in situ cancer of the cervix • Any medical condition rendering the patient unfit for standard of care pre-operative therapy (chemotherapy or endocrine therapy in the respective SoC treatment group) • Concurrent or prior systemic antitumor therapy T or T->EC • Clinically significant cardiovascular disease (including unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months prior to study entry) at low dose (< 20 mg methylprednisolone or equivalent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare efficacy of pre-operative standard of care treatment with or without a therapeutic cancer vaccine (L-BLP25), measured by Residual Cancer Burden (RCB) at the time of surgery;Secondary Objective: • to compare the efficacy of pre-operative standard of care treatment with or without a therapeutic cancer vaccine (L-BLP25), when measured by pathological complete remission (pCR, =absence of invasive cancer cells in surgical specimen) at the time of surgery. • to detect differences in the efficacy between reverse versus conventional sequenced chemotherapy with or without L-BLP25, when measured by RCB. • to compare safety and tolerability of standard of care pre-operative treatment with or without a therapeutic cancer vaccine (L-BLP25). • to compare differences in tumor associated lymphocytes and ki67 status along the course of therapy in women who receive standard of care pre-operative treatment with or without L-BLP25 • to evaluate Quality of Life in women treated with our without a therapeutic cancer vaccine (L-BLP25) • additional sensitivity analyses of subgroups according to pre-defined study populations ;Primary end point(s): Histo-pathological response to pre-operative standard of care treatment with or without L-BLP25 therapy when measured by Residual Cancer Burden (RCB0/I versus RCBII/III) at the time of surgery;Timepoint(s) of evaluation of this end point: at the time of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of pathological complete remission (pCR; = absence of invasive cancer cells in surgical specimen) • Efficacy of reverse versus conventional sequence chemotherapy with or without L-BLP25 as measured by RCB • Safety and tolerability of vaccination with L-BLP25 • Proportion of patients with lymphocyte-predominant breast cancer as measured by tumor associated lymphocytes (TAL) and changes in TAL, as well as ki67 status under tumor therapy; • Quality of Life (QoL) • Subgroup analysis according to pre-defined study populations ;Timepoint(s) of evaluation of this end point: • pCR, lymphocyte-predominant breast cancer, KI-67, RCB: at the time of surgery • Safety/tolerabilty: after final surgery • QoL: after the End of Study Visit | — |
Countries
Austria
Contacts
Public ContactTrial Office
ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Outcome results
None listed