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This is a single-center, prospective, single arm phase II study to evaluate the efficacy and safety of nab-paclitaxel plus carboplatin (with trastuzumab for HER-2 positive patients) as neoadjuvant therapy in operable locally advanced breast cancer patients. The primary objective is pCR. The secondary objectives include ORR, 3-yr DFS, OS and safety. The sample size is 30.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-paclitaxel | Drug | nab-paclitaxel 125mg/m2, day 1, 8, 15, q4w; carboplatin AUC 2, day 1, 8, 15, q4w; for HER-2 positive patients: trastuzumab loading dose 4mg/kg, then 2mg/kg, day 1, 8, 15, 22, q4w. All patients will receive up to four cycles except for unacceptable toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate | The percentage of patients with a pathological complete response after neoadjuvant therapy | Obtained within six months of the last patient's enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | The percentage of patients with complete response or partial response after neoadjuvant therapy | Obtained within six months of the last patient's enrollment |
| Three-year disease free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhimin Shao, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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 |
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|
The percentage of patients who survive without breast cancer recurrence or metastases three years after surgery
| Obtained within 42 months after last patient's enrollment |
| Overall survival | The overall survival time of all patients enrolled in the study presented by survival curve and median value | Obtained around 5 years after the last patient's erollment |
| Safety | List and frequencies of adverse events occured during and one-month after the investigational drug treatment | Obtained around six months after the last patient's enrollment |
| 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 |