Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Herceptin is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-authorized companion diagnostic for Herceptin ( 1 , 2.2 ). FDA label
Also known as Herceptin, Trastuzumab
Trastuzumab+ Paclitaxel · 4 trials · 10 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).
at the time of final surgery after 6 cycles of Arm A (Epirubicin/ Docetaxel/ Capecitabine-containing chemotherapy ± Trastuzumab in HER-2 positive disease) vs. Arm B (Epirubicin/Docetaxel-containing chemotherapy ± Trastuzumab in HER-2 positive disease).
Defined as ypT0 ypN0 or ypT0/is ypN0 after 12 weeks of treatment by trastuzumab + paclitaxel ± pegfilgrastim with ypT0/Tis ypN0 defined as absence of invasive cancer in the breast and axillary nodes in all surgically excised specimens.
Recommended Doses of the combination treatment
% pathological Complete Response achieved according to Miller and Payne Criteria
| 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. |
| A (experimental group) | ACTIVE_COMPARATOR | Epirubicin/Docetaxel/Capecitabine-containing chemotherapy ± trastuzumab in HER-2 positive disease |
| B (control group) | ACTIVE_COMPARATOR | Epirubicin/Docetaxel-containing chemotherapy ± trastuzumab in HER-2 positive disease |
| Paclitaxel+Trastuzumab+Pegfilgrastim | EXPERIMENTAL | NEOADJUVANT TREATMENT PERIOD (up to 12 weeks) :Paclitaxel (80 mg/m2, weekly (D1, D8, D15), IV) + Trastuzumab (a loading dose 8 mg/kg at C1D1 followed by 6 mg/kg Q3W, IV OR 600mg, Q3W SC) + Pegfilgrastim (6 mg, Q3W, subcutaneously, the day after the trastuzumab + paclitaxel infusion (i.e. Day 2 of each cycle)). ADJUVANT TREATMENT PERIOD (up to 12 months) : Trastuzumab (a loading dose 8 mg/kg at C1D1 followed by 6 mg/kg Q3W, (IV) OR 600mg, Q3W SC) |
| Paclitaxel+Trastuzumab | ACTIVE_COMPARATOR | NEOADJUVANT TREATMENT PERIOD (up to 12 weeks) :Paclitaxel (80 mg/m2, weekly (D1, D8, D15), IV) + Trastuzumab (a loading dose 8 mg/kg at C1D1 followed by 6 mg/kg Q3W, IV OR 600mg, Q3W SC). ADJUVANT TREATMENT PERIOD (up to 12 months) : Trastuzumab (a loading dose 8 mg/kg at C1D1 followed by 6 mg/kg Q3W, (IV) OR 600mg, Q3W SC) |
| Myocet+Taxotere+Herceptin | EXPERIMENTAL | Myocet 50 mg/m2; Taxotere 60 mg/m2; Herceptín 4 mg/Kg (first dose) and in the following cycles 2 mg/Kg |
| 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. |
| Docetaxel | DRUG | 6 cycles 75mg/m2 i.v. day 1 q3w |
| Capecitabine | DRUG | 6 cycles 1000mg/m2 oral, day 1-14 q2d |
| Trastuzumab + Paclitaxel | DRUG | During neoadjuvant period, weekly paclitaxel + trastuzumab (every 3 weeks, Q3W) During adjuvant period, weekly trastuzumab (every 3 weeks, Q3W) |
| Pegfilgrastim | DRUG | During neoadjuvant period, weekly pegfilgrastim (every 3 weeks, Q3W) |
| Myocet | DRUG | Myocet®: 60-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles |
| Taxotere | DRUG | Taxotere® 70-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles |
| Herceptin | DRUG | Herceptin® (4) 2 mg/kg (vía IV) Semanal for 6 cycles |
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...
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Trastuzumab + Paclitaxel is used in the treatment of breast cancer, including HER2-positive breast cancer and tubular breast cancer stage II. It is studied in both early and operable HER2-positive disease, often as part of neoadjuvant or combination regimens.
Trastuzumab + Paclitaxel targets ERBB2, also known as HER2. Trastuzumab is a monoclonal antibody inhibitor of ERBB2, while paclitaxel is a chemotherapy agent. The combination is designed to block HER2 signaling and deliver cytotoxic chemotherapy in HER2-positive breast cancer.
Amgen Inc. (ticker: AMGN) is the developer associated with Trastuzumab + Paclitaxel. The drug is being studied in oncology, specifically in breast cancer indications.
Trastuzumab + Paclitaxel is in Phase 3 clinical development. It is an investigational combination and has not been approved by the FDA for the studied indications. The Phase 3 program includes active-controlled trials in HER2-positive and other breast cancer subtypes.
Trastuzumab + Paclitaxel has been studied in clinical trials including NCT03571633, a Phase 2 trial in operable HER2-positive breast cancer, and NCT02125344, a Phase 3 trial in high-risk early breast cancer. Other trials include NCT00309556 and NCT00129896.