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Herceptin · 1 trial · 1 indication
Disease-free survival (DFS) for all patients regardless of randomization will be determined by patients' own physicians at the individual study sites during routine follow-up screening. This will occur every three months for the first 24 months after completion of primary therapies and every six months thereafter with clinical exam, and laboratory and radiographic surveillance. The primary objective of the study is disease-free survival (DFS) at 24 months.
| Arm | Type | Description |
|---|---|---|
| Herceptin + NeuVax vaccine | EXPERIMENTAL | Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year; the first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive vaccinations of NeuVax vaccine administered intradermally every 3 weeks for 6 total vaccinations, 30-120 minutes after completion of Herceptin infusion. The NeuVax vaccine series will begin immediately after completion of the third Herceptin infusion, but may be delayed to the fourth or fifth Herceptin infusion with prior approval from the PI. Patients will be blinded regarding assigned arm. After completion of primary vaccine series, patients will receive 4 NeuVax vaccine booster inoculations to be administered every 6 months x 4 for total treatment duration of 30 months. |
| Herceptin + GM-CSF only | ACTIVE_COMPARATOR | Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year. The first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive inoculations of GM-CSF only (250mcg) administered intradermally every 3 weeks for 6 total inoculations, 30-120 minutes after completion of Herceptin infusion. The GM-CSF only inoculation series will begin immediately after completion of the third Herceptin infusion. Patients will be blinded as to whether they are receiving NeuVax vaccine or GM-CSF only. After completion of six-inoculation primary vaccine series, patients will then receive a total of four GM-CSF only booster inoculations to be administered at 12, 18, 24, and 30 months from the date of the first Herceptin infusion. |
| Name | Type | Description |
|---|---|---|
| Herceptin | DRUG | Herceptin will be administered to patients every three weeks as monotherapy for one year, to be given upon completion of standard of care chemotherapy/radiotherapy. The first Herceptin infusion will be given no sooner than three weeks and no later than 12 weeks after completion of chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. |
| NeuVax vaccine | DRUG | At the time of vaccine administration, a frozen solution of E75 acetate (1.5mg/ml) is thawed and 1000mcg E75 peptide mixed thoroughly with 250mcg GM-CSF. This constitutes the NeuVax vaccine. For patients randomized to the Herceptin + NeuVax vaccine arm, they will commence Herceptin monotherapy and then will begin the NeuVax vaccine series immediately after completion of the third Herceptin infusion. The vaccine series consists of NeuVax vaccine administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of Herceptin infusion. |
| GM-CSF | DRUG | For patients randomized to the Herceptin + GM-CSF only arm, they will commence Herceptin monotherapy and then will begin the GM-CSF inoculation series immediately after completion of the third Herceptin infusion. The GM-CSF inoculation series consists of 250mcg GM-CSF administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of Herceptin infusion. |
Patients will be included in the study based on the following criteria: * Women 18 years or older * Node-positive breast cancer (AJCC N1, N2, or N3) * Node-negative breast cancer if negative for both estrogen (ER) and progesterone (PR) receptors and have received chemotherapy as standard of care * ...
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Herceptin is used for breast cancer. It is being studied in combination with the HER2 vaccine NeuVax as a form of combination immunotherapy. The drug is currently in Phase 2 clinical development for this indication.
Herceptin is being developed by SELLAS Life Sciences Group, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SLS. The company is conducting clinical trials to evaluate the drug's efficacy in breast cancer patients.
Herceptin is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being evaluated in a completed Phase 2 trial for the treatment of breast cancer.
Herceptin is associated with one completed clinical trial, NCT01570036, titled 'Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax.' This Phase 2 trial enrolled 275 female patients with breast cancer in the United States and used an active-controlled design.
No, Herceptin is not the same as NeuVax. Herceptin is the investigational drug being studied, while NeuVax is a HER2 vaccine used in combination with Herceptin in the clinical trial. They are distinct agents evaluated together as combination immunotherapy.
Yes, the Herceptin Phase 2 trial was randomized and biomarker-selected. The trial enrolled 275 patients and was active-controlled, meaning patients received either the combination therapy or an active comparator. The trial was not double-blind.