Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nab-Paclitaxel · 1 trial · 1 indication
PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 millimeter (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method.
| Arm | Type | Description |
|---|---|---|
| Trastuzumab deruxtecan | EXPERIMENTAL | Trastuzumab deruxtecan (T-DXd; DS-8201a) arm |
| Standard of Care | ACTIVE_COMPARATOR | Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm |
| Name | Type | Description |
|---|---|---|
| Trastuzumab deruxtecan | DRUG | Trastuzumab deruxtecan by intravenous infusion |
| Capecitabine | DRUG | Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally. |
| Paclitaxel | DRUG | Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion. |
| Nab-Paclitaxel | DRUG | Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion |
Key Inclusion Criteria: * Patients must be ≥18 years of age * Pathologically documented breast cancer that: 1. is advanced or metastatic 2. has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) 3. ...
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Nab-Paclitaxel is being studied for use in advanced or metastatic breast cancer and small cell lung carcinoma. It is an oncology small molecule being evaluated in combination with other agents as part of clinical trials for these indications.
Nab-Paclitaxel is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the drug in oncology indications.
Nab-Paclitaxel is in Phase 3 clinical development. It is an investigational drug being studied in active clinical trials for advanced or metastatic breast cancer and is not yet approved by regulatory authorities.
Nab-Paclitaxel is part of the Phase 3 trial NCT04494425, which studies trastuzumab deruxtecan versus investigator's choice chemotherapy in HER2-low, hormone receptor positive, metastatic breast cancer. This trial has enrolled 866 participants across multiple countries.
Nab-Paclitaxel is also known as Nab-paclitaxel+carboplatin, which refers to the combination regimen being studied. The drug is being evaluated in combination with carboplatin in clinical trials for certain cancers.