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The purpose of this study is to assess the response of docetaxel and gemcitabine in the neoadjuvant setting in women with locally advanced breast cancer.
Neoadjuvant chemotherapy is now standard for patients with locally advanced breast cancer, and this method of treatment has been extended to patients with earlier disease without affecting the treatment outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of docetaxel and gemcitabine in the neoadjuvant setting with locally advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| docetaxel/gemcitabine | Experimental | All the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate was assessed by pathologic examination after surgery. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Type of surgery (Breast Conserving Rate) | 6 month | |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 1 year | |
| progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ku Sang Kim, M.D. | Contact | 82-31-219-5200 | ideakims@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Young Jin Suh, M.D. Ph.D | Department of Surgery, the Catholic university of Korea, St. Vincent's hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, the Catholic university of Korea, St. Vincent's hospital | Suwon | Gyeonggi-do | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29285038 | Derived | Jeon YW, Kim TH, Youn HJ, Han S, Jung Y, Gwak G, Park YS, Kim JS, Suh YJ. A Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Docetaxel and Gemcitabine in Locally Advanced Breast Cancer. J Breast Cancer. 2017 Dec;20(4):340-346. doi: 10.4048/jbc.2017.20.4.340. Epub 2017 Dec 19. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 31, 2017 | |
| Reset | Aug 2, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 31, 2017 | Aug 2, 2018 |
| 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 |
|---|---|
| D000077143 | Docetaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| gemcitabine | Drug | gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles |
|
|
| 2 years |
| quality of life | 2 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |