Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hormonal Therapy · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Trastuzumab, Docetaxel, and Bevacizumab | EXPERIMENTAL | Participants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of \<70% will receive trastuzumab and docetaxel along with bevacizumab in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the bevacizumab infusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment. |
| Trastuzumab and Docetaxel | ACTIVE_COMPARATOR | Participants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of \<70% will receive trastuzumab and docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the study treatment perfusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment. |
| Trastuzumab and Docetaxel (Standard Regimen) | ACTIVE_COMPARATOR | Participants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of \>/=70% will receive trastuzumab and docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the study treatment perfusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment. |
| Name | Type | Description |
|---|---|---|
| Bevacizumab | DRUG | Bevacizumab at a dose of 15 mg/kg will be administered as IV infusion over 90 minutes from Cycles 3-6 (1 Cycle=21 days). |
| Docetaxel | DRUG | Docetaxel at a dose of 100 mg/m\^2 will be administered as IV infusion from Cycles 1-6 (1 Cycle=21 days). |
| Trastuzumab | DRUG | Trastuzumab will be administered as a loading dose of 8 mg/kg as IV infusion in Cycle 1, followed by subsequent dose of 6 mg/kg as IV infusion in Cycles 2 to 7, and during additional 11 cycles post surgery (1 Cycle=21 days). |
| Surgery | PROCEDURE | All participants will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the study treatment infusion in Cycle 6 (1 Cycle=21 days). |
| Radiotherapy | RADIATION | All participants will receive radiotherapy starting about 4 to 8 weeks after surgery, and will last around 4 to 6 weeks as per site's standard practice. |
| Hormonal Therapy | DRUG | Participants who are hormone receptors positive, will receive hormonal therapy after completion of radio therapy period as per investigator's discretion and site's standard practice. |
Inclusion Criteria: * Participants with early stage HER2-positive breast cancer * Scheduled to receive neoadjuvant therapy with the objective of conservative surgery * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Exclusion Criteria: * Participants with partial or total l...
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Hormonal Therapy is an investigational small molecule being studied for the treatment of breast cancer. It is currently in Phase 2 clinical development. The therapy is being evaluated in the neoadjuvant setting for early stage HER2-positive breast cancer, according to a completed clinical trial.
Hormonal Therapy is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational oncology treatment for breast cancer.
Hormonal Therapy is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial for the therapy has been completed.
Hormonal Therapy has been studied in one clinical trial, identified as NCT01142778. This was a Phase 2 study that evaluated the therapy in combination with other agents in the neoadjuvant setting for early stage HER2-positive breast cancer. The trial enrolled 152 female participants in France and has been completed.
Hormonal Therapy is not the same as bevacizumab or trastuzumab. The clinical trial NCT01142778 studied the addition of bevacizumab to trastuzumab plus docetaxel, and Hormonal Therapy refers to the overall treatment regimen being investigated. The trial was active-controlled and randomized.