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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a prospective, multi-center, real-world study designed to evaluate the efficacy and safety of albumin-bound paclitaxel versus paclitaxel or docetaxel in adjuvant treatment of breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC followed by albumin-bound paclitaxel | Experimental | A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by albumin-bound paclitaxel for 4 cycles. |
|
| AC followed by taxanes | Active Comparator | A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxorubicin | Drug | doxorubicin 50~60mg/m2, i.v., d1, q3w or q2w. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5-year invasive disease-free survival (IDFS) rate | Invasive disease free survival was defined as the time from enrollment until the date of first occurrence of one of the following events: invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence (including first metastasis), invasive contralateral breast cancer, second primary invasive cancer (nonbreast, not including squamous or basal cell skin cancers, or new in situ carcinomas of any site), or death from any cause. 5-year IDFS rate is thepercentage of participants with IDFS from enrollment through 5 years. | up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| IDFS | Invasive disease free survival was defined as the time from enrollment until the date of first occurrence of one of the following events: invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence (including first metastasis), invasive contralateral breast cancer, second primary invasive cancer (nonbreast, not including squamous or basal cell skin cancers, or new in situ carcinomas of any site), or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiao Li, MD | Contact | 86-10-87788120 | liqiaopumc@yahoo.cn | |
| Binghe Xu, PHD | Contact | 86-10-87788495 | xubinghe@medmail.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, ChineseAMS | 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 |
|---|---|
| D004317 | Doxorubicin |
| D015251 | Epirubicin |
| C027260 | pirarubicin |
| D003520 | Cyclophosphamide |
| D000068196 | Albumin-Bound Paclitaxel |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| epirubicin | Drug | epirubicin 80~100mg/m2, i.v., d1, q3w or q2w. |
|
| pirarubicin | Drug | pirarubicin 40~50mg/m2, i.v., d1, q3w or q2w. |
|
| cyclophosphamide | Drug | cyclophosphamide 600mg/m2, i.v., d1, q3w or q2w. |
|
| albumin-bound paclitaxel | Drug | albumin-bound paclitaxel 260mg/m2, i.v., d1, q3w; 260mg/m2, i.v., d1, q2w; or 125mg/m2, i.v., d1, qw. |
|
| paclitaxel | Drug | paclitaxel 175mg/m2, i.v., d1, q3w; 175mg/m2, i.v., d1, q2w; or 80mg/m2, i.v., d1, qw. |
|
| docetaxel | Drug | docetaxel 80~100mg/m2, i.v., d1, q3w. |
|
| up to 60 months |
| overall survival (OS) | OS was defined as the time from enrollment assignment to death as a result of any cause. | up to 60 months |
| 3-year invasive disease-free survival (IDFS) rate | 3-year IDFS rate is the percentage of participants with IDFS from enrollment through 3 years. | up to 36 months |
| Incidence and severity of adverse events | Adverse events as assessed by NCI-CTCAE V5.0 | up to 60 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |