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Also known as Herceptin®, Herceptin
Trastuzumab · 5 trials · 6 indications
Evaluate the ability of tucatinib in combination with trastuzumab/pertuzumab or TDM-1 to prolong intracranial progression free survival (PFS) in patients compared to historical controls. PFS is defined as the time from the day of study treatment initiation until evidence of intracranial disease progression per RANO-BM or death from any cause.
Progression Free Survival is defined from the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST 1.1 or death from any cause, whichever occurs first.
cORR was defined as the percentage of participants with confirmed CR or PR according to RECIST v1.1. CR was defined as the disappearance of all target lesions and each target lymph node must have reduction in short axis to less than (\<)1.0 centimeter (cm). PR was defined as at least a 30 percentage (%) decrease in post-baseline sum of the diameters (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline sum of diameters.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
| Arm | Type | Description |
|---|---|---|
| Experimental Group | EXPERIMENTAL | Trastuzumab/pertuzumab + tucatinib or T-DM1 + tucatinib 300mg of tucatinib taken orally twice a day. Taken on Days 1-21 of a 21 Day cycle (3 Weeks). Trastuzumab/Biosimilar administered per current package insert based on site standard of care guidelines Pertuzumab or Biosimilar administered per current package insert based on site standard of care guidelines Trastuzumab Emtansine (T-DM1) administered per current package insert based on site standard of care guidelines |
| NH: Trastuzumab + Vinorelbine | EXPERIMENTAL | * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle |
| NHA: Trastuzumab + Vinorelbine + Avelumab | EXPERIMENTAL | * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab |
| NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab | EXPERIMENTAL | * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab * Utomilumab is administered intravenously once per cycle |
| Cohort A: Tucatinib + Trastuzumab | EXPERIMENTAL | Non-randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days. |
| Cohort B: Tucatinib + Trastuzumab | EXPERIMENTAL | Randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days. |
| Cohort C: Tucatinib Monotherapy | EXPERIMENTAL | Randomized cohort. Participants take tucatinib twice per orally every day. Participants who do not respond to therapy may have the option to receive tucatinib and trastuzumab. |
| Cohort 1 | EXPERIMENTAL | 0.04 mg/kg CpG 7909 |
| Cohort 2 | EXPERIMENTAL | 0.08 mg/kg CpG 7909 |
| Cohort 3 | EXPERIMENTAL | 0.12 mg/kg CpG 7909 Injection once weekly |
| Cohort 4 | EXPERIMENTAL | 0.16 mg/kg CpG 7909 |
| 1 | EXPERIMENTAL | Combination of SU011248 (37.5 mg once daily \[Schedule 2/1\]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose) |
| Name | Type | Description |
|---|---|---|
| Trastuzumab | DRUG | Administer per current package insert based on site standard of care guidelines |
| Trastuzumab Emtansine (T-DM1) | DRUG | Administer per current package insert based on site standard of care guidelines |
| Pertuzumab | DRUG | Administer per current package insert based on site standard of care guidelines |
| Tucatinib | DRUG | 300 mg orally twice daily (21 Day Cycle) |
| Vinorelbine | DRUG | work by interfering with cell division, which leaves the tumor unable to grow and spread |
| Avelumab | DRUG | monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein |
| Utomilumab | DRUG | Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells |
| 0.04 mg/kg CpG 7909 | DRUG | 0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks |
| Herceptin® | DRUG | Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909. |
| 0.08 mg/kg CpG 7909 | DRUG | 0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks |
| 0.12 mg/kg CpG 7909 | DRUG | 0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks |
| 0.16 mg/kg CpG 7909 | DRUG | 0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks |
| Herceptin | DRUG | Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks. |
| Sunitinib | DRUG | SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued. |
| Taxotere | DRUG | The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion. |
Inclusion Criteria: Subject must meet all of the following applicable inclusion criteria to participate in this study: * Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed cons...
Herceptin is used for breast cancer, specifically carcinoma of the breast. It is being studied in patients with metastatic breast cancer and in those with HER-2 positive advanced breast cancer. The drug is in clinical development for these oncology indications.
Herceptin targets ERBB2, also known as HER2, and acts as an inhibitor of this molecular target. By inhibiting ERBB2, the drug is designed to interfere with signaling pathways that can drive cancer cell growth in breast cancer.
Herceptin is developed by Pfizer, Inc., which trades under the ticker symbol PFE on the stock exchange. Pfizer is the company responsible for the clinical development of this drug for breast cancer indications.
Herceptin is in Phase 1 clinical development. It has completed one Phase 1 trial and one Phase 2 trial, but the current development stage is Phase 1. Herceptin is investigational and has not been approved by regulatory authorities.
Herceptin has been studied in two completed clinical trials. NCT00043394 was a Phase 2 study of CPG 7909 plus Herceptin in patients with metastatic breast cancer. NCT00372424 was a Phase 1 study of SU011248 in combination with docetaxel and trastuzumab in patients with HER-2 positive advanced breast cancer.
Yes, Herceptin is also known as Trastuzumab. The drug is sometimes referred to by its generic name, trastuzumab, and is also studied in combination products such as Trastuzumab plus Pertuzumab. These names refer to the same therapeutic agent.