Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Municipal Science & Technology Commission | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Chinese Academy of Medical Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this phase â…¢, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel/anthracycline | Drug | standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel) |
|
| Measure | Description | Time Frame |
|---|---|---|
| distant disease-free survival (DDFS) | 3 years after surgery |
Not provided
Not provided
Inclusion Criteria:
Female patients, age ≦65 years
Biopsy proven lymph node positive, estrogen receptor- positive primary breast cancer
Must have completed a 4-cycle neo-adjuvant chemotherapy with a standard regimen(containing anthracycline or paclitaxel)
Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
Postoperative residual positive lymph nodes or G1/G2/G3 of Miller & Payne Grading System
Adequate recovery from recent surgery
No history of other malignancies
No currently uncontrolled diseased or active infection
Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
Adequate cardiovascular function reserve with a myocardial infarction within the past six month
Adequate hematologic function with:
Adequate hepatic and renal function with:
Knowledge of the investigational nature of the study and Ability to give informed consent
Ability and willingness to comply with study procedures.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tao Ouyang, Doctor | Beijing Cancer Hospital Breast Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 307 Hospital of Pla | Beijing | China | ||||
| Beijing Cancer Hospital Breast Center |
Not provided
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D018943 | Anthracyclines |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
| Peking University First Hospital |
| OTHER |
| Peking University People's Hospital | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| 307 Hospital of PLA | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Beijing |
| China |
| Beijing Chao-Yang Hospital | Beijing | China |
| Cancer Institution and Hospital.Chinese Academy of Medical Sciences | Beijing | China |
| Peking Union Medical College Hospital | Beijing | China |
| Peking University First Hospital | Beijing | China |
| Peking University People'S Hospital | Beijing | China |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |