Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Standard-of-Care · 1 trial · 1 indication
compared between patients treated with T-DXd neoadjuvant monotherapy for 18 weeks (part 1, cohort 2) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)
dDFS in patients with T-DXd neoadjuvant monotherapy (pooled experimental treatment arms of part 1, pooled cohorts 1 and 2)
in patients with T-DXd neoadjuvant therapy followed by CHT (pooled experimental treatment arms of part 2, cohort 3)
defined as ypT0is/ypN0, compared between patients treated with T-DXd neoadjuvant monotherapy (pooled experimental treatment arms of part 1, pooled cohorts 1 and 2) compared to patients of corresponding standard-of-care treatments (DOC/PAC+T+P or DOC/PAC+Carbo+T+P) (pooled standard-of-care treatment arms of part 1, pooled cohorts 1 and 2)
| Arm | Type | Description |
|---|---|---|
| T-DXd 12 weeks: HER2+ and low-intermediate risk for recurrence | EXPERIMENTAL | 12 weeks T-DXd i.v. in neoadjuvant treatment; pCR dependent T-DXd for 1 year in total in postneoadjuvant treatment |
| T-DXd 18 weeks: HER2+ and intermediate-high risk for recurrence | EXPERIMENTAL | 18 weeks T-DXd i.v. in neoadjuvant treatment; pCR dependent T-DXd for 1 year in total in postneoadjuvant treatment |
| Control SoC CTx 12 weeks: HER2+ and low-intermediate risk for recurrence | OTHER | Standard-of-Care-Treatment: 12 weeks PAC+T+P (standard-of-care) in neoadjuvant treatment; pCR dependent SOC chemotherapy +T+/-P or SOC T+/-P for 1 year in total in postneoadjuvant treatment |
| Control SoC CTx 18 weeks: HER2+ and intermediate-high risk for recurrence | OTHER | Standard-of-Care-Treatment: 18 weeks PAC/DOC+Carbo+T+P (standard-of-care) in neoadjuvant treatment; pCR dependent SOC chemotherapy +T+/-P or SOC T+/-P for 1 year in total in postneoadjuvant treatment |
| T-DXd 12 weeks + SoC CTx 6 weeks | EXPERIMENTAL | 12 weeks T-DXd i.v. follwed by 6 weeks SoC chemotherapy in neoadjuvant treatment; pCR dependent postneoadjuvant treatment: * non-pCR: 14 cycles of T-DXd is strongly recommended or SoC treatment, i.e., chemotherapy and anti-HER2-treatment, including T-DM1 at investigator´s decision * pCR: SoC treatment, e.g., T +/- P or T-DM1 (at investigator´s decision) |
| T-DXd 12 weeks + SoC CTx 12 weeks | EXPERIMENTAL | 12 weeks T-DXd i.v. follwed by 12 weeks SoC chemotherapy in neoadjuvant treatment; pCR dependent postneoadjuvant treatment: * non-pCR: 14 cycles of T-DXd is strongly recommended or SoC treatment, i.e., chemotherapy and anti-HER2-treatment, including T-DM1 at investigator´s decision * pCR: SoC treatment, e.g., T +/- P or T-DM1 (at investigator´s decision) Therapy for patients with non-pCR who received neoadjuvant T-DXd (12 weeks) + 12 weeks (4 cycles) of SoC chemotherapy will exceed total therapy over one year. Here, approximately 66 weeks are considered as maximum therapy (individual variations may apply) |
| SoC CTx 18 weeks | OTHER | Standard-of-Care-Treatment: 18 weeks PAC/DOC+Carbo+T+P (standard-of-care) in neoadjuvant treatment; pCR dependent SOC chemotherapy +T+/-P or SOC T+/-P for 1 year in total in postneoadjuvant treatment * non-pCR (in particular ypT \>1b (5 mm) or ypN+: 14 cycles with T-DXd recommended * pCR: SoC treatment, e.g., T +/- P or T-DM1 (at investigator´s decision) Therapy for patients with non-pCR who received neoadjuvant SoC chemotherapy will exceed total therapy over one year. Here, approximately 60 weeks are considered as maximum therapy (individual variations may apply). |
| Name | Type | Description |
|---|---|---|
| Trastuzumab deruxtecan | DRUG | T-DXd i.v. |
| Standard-of-Care | DRUG | Chemotherapy+T+P |
Inclusion Criteria: Patients eligible for inclusion in this study must meet all the following criteria: 1\. Female patients with invasive, untreated HER2+ breast cancer (as assessed by local pathology) maximum 6 weeks before registration (standard-of-care diagnostic biopsy according to current AGO...
Standard-of-Care is being studied for the treatment of HER2-positive early breast cancer. It is currently in Phase 2 clinical development as part of a neoadjuvant therapy trial, where it is compared against a regimen of chemotherapy plus trastuzumab and pertuzumab in female patients aged 18 years and older.
Standard-of-Care is being developed by AstraZeneca PLC, which is listed on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 2 clinical trial to evaluate this treatment in patients with HER2-positive early breast cancer.
Standard-of-Care is currently in Phase 2 clinical development. It is an investigational therapy being studied in a randomized, controlled trial for HER2-positive early breast cancer. The trial is actively recruiting participants, and the drug has not yet been approved by regulatory authorities.
Standard-of-Care is being evaluated in a single Phase 2 clinical trial with the identifier NCT05704829. This trial, titled 'NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer', is recruiting 702 female participants in Germany and is currently in the recruiting stage.
No, Standard-of-Care is not the same as trastuzumab-deruxtecan. In the clinical trial NCT05704829, Standard-of-Care refers to the control arm, which consists of chemotherapy plus trastuzumab and pertuzumab. Trastuzumab-deruxtecan is the experimental treatment being compared against this standard-of-care regimen.