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Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (pre- + postoperative chemotherapy) | Experimental | 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF. |
|
| B (conventional postoperative chemotherapy) | Experimental | Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide 600mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | ||
| Recurrence-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of breast-conserving procedures |
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Inclusion Criteria:
Patients with bioptically verified breast cancer
Estrogen receptor-negative status
Age: < 70 years
WHO Performance Status < 2
Laboratory parameters
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| Name | Affiliation | Role |
|---|---|---|
| Raimund Jakesz, MD | Austrian Breast & Colorectal Cancer Study Group | Principal Investigator |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Methotrexate | Drug | Methotrexate 40mg/m2 |
|
| Fluorouracil | Drug | Fluorouracil 600mg/m2 |
|
| Epirubicin | Drug | Epirubucin 60mg/m2 (only node-positive patients) |
|
| Surgery | Other | Surgery |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D008727 | Methotrexate |
| D005472 | Fluorouracil |
| D015251 | Epirubicin |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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