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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin(PLD)plus Albumin-Bound Paclitaxel and trastuzumab as neoadjuvant therapy in HER-2 positive breast cancer.
This is a single-center, prospective, single arm phase II study. Eligible patients will receive neoadjuvant therapy with pegylated liposome doxorubicin (PLD)/albumin-bound paclitaxel/trastuzumab regimentation.
This study consists of two phases, the first phase aims to determine the maximum tolerated dose (MTD) of PLD, and the second phase will explore the efficacy and safety of the regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLD/albumin-bound paclitaxel/Trastuzumab | Experimental | First phase PLD: Level 1:30mg/m2; Level 2:35mg/m2; Level 3:40mg/m2; IV, d1, q21d×6. albumin-bound paclitaxel: 220mg/m2 IV for the first infusion,Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6. Trastuzumab:8mg/kg IV for the first infusion , Subsequent infusions 6mg/kg. d1, q21d×6. Second phase PLD: maximum tolerated dose (MTD). IV, d1, q21d×6. albumin-bound paclitaxel: 220mg/m2 IV for the first infusion,Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6. Trastuzumab:8mg/kg IV for the first infusion ,Subsequent infusions 6mg/kg. d1, q21d×6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Liposomal Doxorubicin | Drug | First phase PLD: 30mg/m2;35mg/m2;40mg/m2;IV, d1, q21d×6. Second phase PLD:MTD. IV, d1, q21d×6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response(pCR) rate | Percentage of patients who do not exhibit residual invasive breast cancer in breast and lymph nodes at time of surgery | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Breast conserving surgery | Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy | 5 months |
| Rate of surgery | Percentage of patients undergoing mastectomy and breast-conserving surgery after neoadjuvant therapy |
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Inclusion Criteria:
Exclusion Criteria:
1) Significant ventricular arrhythmia or high degree atrioventricular block (Mobitz II or third degree atrioventricular block); 2) unstable angina; 3) clinically significant heart valve disease; 4) Electrocardiogram shows transmural myocardial infarction; 5) Uncontrolled hypertension. 6. Uncontrolled diabetes. 7. Severe or uncontrolled infection. 8. Hepatitis b surface antigen positive, or hepatitis c virus antibody positive, or human immunodeficiency virus (HIV) antibody positive.
9. Active malignancy, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin,within the past 5 years.
9)Women who are pregnant , breastfeeding ,or refuse to use adequate contraception prior to study entry and for the duration of study participation.
10)Other conditions considered to be inappropriate to be enrolled by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Ma, MD | Contact | +8613910217780 | 13910217780@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Fei Ma, MD | Cancer Hospital Chinese Academy of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fei Ma | Recruiting | Beijing | Beijing Municipality | 100021 | 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 |
|---|---|
| C506643 | liposomal doxorubicin |
| D000068196 | Albumin-Bound Paclitaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| Albumin-bound paclitaxel | Drug | 220mg/m2 IV for the first infusion,Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6. |
|
| Trastuzumab | Drug | 8mg/kg IV for the first infusion. Subsequent infusions 6mg/kg. d1, q21d×6. |
|
| 5 months |
| adverse events | Incidence and Severity of adverse events ,according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0 | 5 months |
| 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 |