Adenocarcinoma Breast Stage IV
Conditions
Keywords
Hormone receptor positive
Brief summary
The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer.
Detailed description
This is a multicentre, placebo-controlled, double-blind, 1:1 randomised Phase IIb study in female hormone receptor-positive metastatic breast cancer patients. The study comprises of two stages. Stage 1 is the open-label, safety run-in stage consisting of cohort 1 and 2 to confirm the (RPTD) of IMP321 in combination with paclitaxel. Stage 2 is placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo.
Interventions
BIOLOGICALIMP321 (eftilagimod alpha)
In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo
DRUGPlacebo
In the placebo-controlled, double-blind randomisation stage, paclitaxel + placebo will be compared to paclitaxel + IMP321 at the RPTD
DRUGPaclitaxel
Paclitaxel will be given in both treatment arms (classified as Non IMP)
Sponsors
Immutep S.A.S.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to give written informed consent and to comply with the protocol 2. Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis 3. Female of age 18 years or above 4. Patients who are indicated to received first line chemotherapy with weekly paclitaxel 5. Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1 6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.
Exclusion criteria
1. Prior chemotherapy for metastatic breast adenocarcinoma 2. Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy 3. Inflammatory carcinoma 4. Candidate for treatment with trastuzumab (or other Her2/neu targeted agents) 5. Systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week prior to first dose of study treatment or CDK4/6 inhibitors within 5 times half-life (acc.to SPC) prior to first dose of study treatment and until completion of study treatment 6. Symptomatic known cerebral and/or leptomeningeal metastases 7. Serious intercurrent infection 8. Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment 9. Active acute or chronic infection 10. Active autoimmune disease requiring immunosuppressive therapy 11. Previous malignancies within the last three years other than breast carcinoma 12. Patients with prior organ or stem cell transplantation 13. Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Progression-Free Survival (PFS) | Up to 37 month |
| Stage 1 to determine the recommended phase two dose for the randomised phase | Up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the overall survival (OS) | Up to 48 month |
| Stage 1: Evaluation of the pharmacokinetic e.g. Peak Plasma Concentration [Cmax] | Up to 12 months |
| Assessment of the change in quality of life (QOL) | Up to 37 months |
| Evaluation of objective response rate (ORR) | Up to 37 months |
| Evaluation of stable disease | Up to 37 months |
| Evaluation of the time to next treatment | Up to 37 months |
| Assessment of the safety and tolerability of IMP321 as compared to placebo | Up to 19 months |
Other
| Measure | Time frame |
|---|---|
| Stage 1: assessment of Immuno-monitoring in a defined subset of 60 patients during the randomised stage | Up to 37 months |
Countries
Belgium, France, Germany, Hungary, Netherlands, Poland, United Kingdom
Outcome results
None listed