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non-pegylated liposomal doxorubicin · 1 trial · 7 indications
To compare the pathological complete response (pCR= ypT0/is ypN0) rates of neoadjuvant treatment with sequential, dose-dense, dose-intensified ETC(+HP) vs. weekly PM(Cb)(+HP) in patients with high-risk operable or locally advanced breast cancer. Masked role for assessor.
Only for those patients randomized for the supportive anemia treatment: To compare the frequency of patients reaching hemoglobin (Hb) levels ≥ 11g/dl 6 weeks after treatment start of a first episode of anemia grade ≥2 (Hb \< 10g/dl) between patients receiving supportive treatment for iron deficiency with parental ferric carboxymaltose versus physician's choice (no supportive treatment, oral iron substitution, erythropoiesis-stimulating agent (ESA), or both).
| Arm | Type | Description |
|---|---|---|
| PM(Cb) | EXPERIMENTAL | PM(Cb): paclitaxel 80mg/m² 18 times weekly simultaneously with NPLD (Myocet®)20mg/m² 18 times weekly simultaneously with carboplatin AUC 1.5 18 times weekly (only in patients with TNBC) Patients with HER2-positive disease will receive trastuzumab 6 (8) mg/kg every 3 weeks and pertuzumab 420 (840) mg every 3 weeks simultaneously to all cycles. |
| ETC | ACTIVE_COMPARATOR | ETC: epirubicin 150mg/m² every 2 weeks for 3 cycles followed by paclitaxel 225 mg/m² every 2 weeks for 3 cycles followed cyclophosphamide 2000 mg/m² every 2 weeks for 3 cycles. Patients with HER2-positive disease will receive trastuzumab 6 (8) mg/kg every 3 weeks and pertuzumab 420 (840) mg every 3 weeks simultaneously to all T and C cycles. |
| Name | Type | Description |
|---|---|---|
| non-pegylated liposomal doxorubicin | DRUG | 20 mg/m2, i.V. 18 times weekly |
| Carboplatin | DRUG | Carboplatin AUC 1.5 18 times weekly (only in patients with triple-negative breast cancer). |
| Paclitaxel | DRUG | paclitaxel 80mg/m² 18 times weekly |
| Epirubicin | DRUG | 150mg/m² every 2 weeks for 3 cycles. |
| Cyclophosphamide | DRUG | 2000 mg/m² every 2 weeks for 3 cycles. |
| Pertuzumab | DRUG | 420 (840) mg every 3 weeks simultaneously to all T and C cycles in the ETC arm and to all cycles in the PM(Cb) arm. |
| Trastuzumab | DRUG | Trastuzumab 6 (8) mg/kg every 3 weeks simultaneously to all T and C cycles in the ETC arm and to all cycles in the PM(Cb) arm. |
| Ferric carboxymaltose | DRUG | after first anemia grade ≥2 and in case of randomisation: Ferric carboxymaltose i.V. 1000 mg followed 1 week later by an injection of ferric carboxymaltose i.V. 500 mg (if body weight is \<70 kg) or 1000 mg (if body weight is ≥70 kg). In case body weight is \<50 kg, both dosages will be reduced to 500 mg each. |
Inclusion Criteria: Patients will be eligible for study participation only if they comply with the following criteria: * Written informed consent according to local regulatory requirements prior to beginning specific protocol procedures. * Complete baseline documentation must be submitted via MedC...
Non-pegylated liposomal doxorubicin is being studied for the treatment of tubular breast cancer stage II, as well as other high-risk early breast cancer types including tubular breast cancer stage III, mucinous breast cancer stage II, invasive ductal breast cancer, HER2 positive breast cancer, and inflammatory breast cancer. It is an investigational small molecule oncology therapy.
Amgen Inc. (NASDAQ: AMGN) is developing non-pegylated liposomal doxorubicin. The drug is currently in Phase 3 clinical development for the treatment of high-risk early breast cancer.
Non-pegylated liposomal doxorubicin is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. It is being evaluated in a completed Phase 3 trial for the neoadjuvant treatment of high-risk early breast cancer.
Non-pegylated liposomal doxorubicin was studied in the clinical trial NCT02125344, titled 'A Phase III Trial Comparing Two Dose-dense, Dose-intensified Approaches (ETC and PM(Cb)) for Neoadjuvant Treatment of Patients With High-risk Early Breast Cancer (GeparOcto)'. This completed trial enrolled 961 female participants aged 18 years and older in Germany.
Non-pegylated liposomal doxorubicin is a liposomal formulation of doxorubicin, an anthracycline chemotherapy agent. It works by intercalating DNA and inhibiting topoisomerase II, which disrupts DNA replication and leads to cancer cell death. The liposomal encapsulation is designed to alter the drug's distribution and potentially reduce certain side effects.