Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| OMC BC-04 | Other Identifier | Osaka Medical College |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of nab-PTX and trastuzumab for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nab-paclitaxel plus trastuzumab | Experimental | Four cycles of nab-PTX 260 mg/m2 with trastuzumab 6 mg/kg (8 mg/kg as the loading dose). One year of adjuvant trastuzumab will be administrated. Anthracycline regimens may be administered by physician's choice for the case expected to have a high risk of recurrence based on the pathological findings of surgical specimen. Adjuvant endocrine therapy may be administrated for the case with weakly hormone-sensitive (1-9% of positive cells) tumor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-paclitaxel | Drug | nab-paclitaxel 260mg/m2 q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate | Up to 12 weeks after the protocol therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | Five years after the last patient enrolled | |
| Objective response rate | Up to 6 weeks after the protocol therapy | |
| Pathological response rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mitsuhiko Iwamoto, MD, PhD | Osaka Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka Medical College | Takatsuki | Osaka | 5698686 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30963212 | Derived | Tanaka S, Matsunami N, Morishima H, Oda N, Takashima T, Noda S, Kashiwagi S, Tauchi Y, Asano Y, Kimura K, Fujioka H, Terasawa R, Kawaguchi K, Ikari A, Morimoto T, Michishita S, Kobayashi T, Sakane J, Nitta T, Sato N, Hokimoto N, Nishida Y, Iwamoto M. De-escalated neoadjuvant therapy with nanoparticle albumin-bound paclitaxel and trastuzumab for low-risk pure HER2 breast cancer. Cancer Chemother Pharmacol. 2019 Jun;83(6):1099-1104. doi: 10.1007/s00280-019-03836-z. Epub 2019 Apr 8. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Trastuzumab | Drug | trastuzumab 6 mg/kg (8 mg/kg as the loading dose) |
|
|
| Up to 12 weeks after the protocol therapy |
| Breast-conserving surgery rate | Up to 6 weeks after the protocol therapy |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Up to 6 weeks after the protocol therapy |
| D017437 |
| Skin and Connective Tissue Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |