HER2-positive Breast Cancer Clinical Trial
Official title:
Docetaxel Plus Atezolizumab Plus Herceptin SC and Pertuzumab (TAHP) for Patients With HER2-positive Early Breast Cancer and Subsequent Atezolizumab Plus Herceptin SC and Pertuzumab (AHP) Adjuvant tHerapy After Surgery
This study was phase IB-II clinical trial that designed to evaluate the efficacy and safety
of docetaxel + atezolizumab + Herceptin sc plus pertuzumab(TAHP) plus adjuvant therapy of
atezolizumab + trastuzumab + pertuzumab(AHP) after surgery in female patients with
HER2-positive early breast cancer.
Adjuvant AHP (atezolizumab + Herceptin SC + pertuzumab) will be continued for remaining 1
year.
For non-p CR patients, they are going to treat with 4 cycles of AC rather than Taxane only
before AHP adjuvant therapy.
A, Neoadjuvant setting); 6 cycles q3weeks, intravenous(IV) administration
- Docetaxel (75mg/m2, intravenous(IV)) Day(D)1
- Atezolizumab (1200mg, IV) D1
- Herceptin sc (600mg subcutaneous(SC))D1
- Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg(IV))D1
B, Adjuvant setting : 11-12 cycles q3weeks [patients with pCR]
- Atezolizumab (1200mg, IV)
- Trastuzumab (600mg, SC)
- Pertuzumab (420mg, IV) D1
[patients with non-pCR]
- Doxorubicin(60mg/m2), cyclophosphamide (600mg/m2) D1 X 4cycles 3weeks
- Atezolizumab (1200mg, IV)
- Trastuzumab (600mg, SC)
- Pertuzumab (420mg, IV) D1 X 11-12 cycles q3weeks
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04095390 -
A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT04578106 -
Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
|
Phase 2 | |
| Completed |
NCT01855828 -
Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer
|
Phase 2 | |
| Terminated |
NCT01912963 -
Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer
|
Phase 2 | |
| Terminated |
NCT01705340 -
Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery
|
Phase 1 | |
| Recruiting |
NCT04094896 -
TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT06087120 -
Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
|
||
| Recruiting |
NCT05346861 -
Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab
|
Phase 3 | |
| Recruiting |
NCT04899908 -
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
|
Phase 2 | |
| Completed |
NCT03330561 -
PRS-343 in HER2-Positive Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04997798 -
Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT04034823 -
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT04756921 -
18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response
|
||
| Completed |
NCT03140553 -
TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT03094052 -
Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib
|
Phase 2 | |
| Recruiting |
NCT05511844 -
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05325632 -
Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
|
Phase 2 | |
| Recruiting |
NCT05710666 -
Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK Study)
|
Phase 2 | |
| Recruiting |
NCT06161922 -
Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
|
||
| Not yet recruiting |
NCT05063643 -
Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude
|