Not provided
Not provided
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 |
|---|---|
| AGO Study Group | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The present clinical trial will investigate the safety and efficacy of a sequential preoperative therapy with Epirubicin/Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab in patients with HER-2 overexpression primary breast cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Epirubicin/Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab in patients with HER-2 overexpression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epirubicin / Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab | Drug | Cycles 1-4 Epirubicin: 90 mg/m2, i.v. day 1 Cyclophosphamide: 600 mg/m2, i.v. day 1 Every 22d Cycles 5-8 Paclitaxel: 175 mg/m2, i.v., 3h-infusion day 1 Trastuzumab: 8 mg/kg i.v. at day 0 of the 5th cycle and thereafter each 6 mg/kg i.v. day 1 in the cycles 6-8 Every 22d |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the rate of cardiac (serious) events NYHA III/IV-and pathological complete remission after study therapy. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess: the rate of breast conserving surgery, the clinical response rates, the histopathological lymph node status after preoperative therapy, the disease-free and overall survival. | 36 months | |
| To evaluate the quality of life. | 36 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Untch, MD, Prof. | AGO Study Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwig Maximillian University Munich, Department of Gynecology and Obstetrics | Munich | Bavaria | D-81377 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22508812 | Derived | von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| D017239 | Paclitaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| 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 |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |