Gynäkologische Onkologie-Klinische Studien

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1 Gynäkologische Onkologie-Klinische Studien Breast cancer A randomized, phase 2 trial of AEZS-108 in chemotherapy refractory triple negative (ER/PR/HER2-negative) LHRH-R positive metastatic breast cancer AEZS local contact : Dr. M. Hellriegel (Sub-Investigator) Ovarian cancer A prospective randomised Phase III trial to evaluate optimal treatment duration of first-line bevacizumab in combination with carboplatin and paclitaxel in patients with primary epithelial ovarian, fallopian tube or peritoneal cancer. The BOOST (Bevacizumab Ovarian Optimal Standard Treatment) Trial- AGO-OVAR 17/BOOST local contact : Dr. M. Hellriegel (Sub-Investigator) A randomized multicenter study to compare the efficacy of additional tumor debulking surgery versus chemotherapy alone for recurrent platinum-sensitive ovarian cancer- AGO-OVAR OP.4 (AGO Desktop Ovar III) local Does Palliativ Chemotherapie Improve Symptoms in Women with Reccurent Ovarian Cancer? Measuring subjective improvement as well as objective response to 1

2 estimate the benefit of palliative chemotherapy in women with platinum resistant or refractory ovarian cancer- AGO-Pro 1 / Symptom Benefit local Endometrium-, Cervixcarcinom, Uterussarcoma u.a. Antitumoral activity and safety of Temsirolimus in advance andometrial cancer and platinum-refractory ovarian cancer- AGO-Gyn 8 Follow-up Studies Breastcancer A randomised three-arm multi-centre comparison of 1 year and 2-years of Herceptin versus no Herceptin in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy-hera A Prospectively Randomized Phase III Trial, studying the benefits of adjuvant sequential vs. combined taxan based chemotherapy and different durations of Zoledronate treatment in early breast cancer: Success Trial-SUCCESS A 2

3 Prospectively randomized phase III trial, studying the benefits of adjuvant sequential anthracycline axane based vs. anthracycline free taxane based chemotherapy, followed by a dietary intervention study in early, HER2-negative breast cancer SUCCESS-C - A randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer. Adjuvante Lapatinib u./o. Trastuzumab Treatment Optimisation (ALLTO) contact: Dr. M. Hellriegel (Senior Assistent Medical Director) A phase III trials program exploring the integration of Bevacizumab, Everolimus (RAD001),and Lapatinib into current neoadjuvant chemotherapy regimes for primary breast cancer -GeparQuinto. 3

4 A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab. Bevacizumab with Trastuzumab Adjuvant Therapy in HER2+ Breast Cancer (Beth) Randomised comparison of adjuvant Docetaxel / Cyclophosphamide with sequential adjuvant EC / Docetaxel chemotherapy in patients with HER2/neu negative early breast cancer 6 x TC vs. 4 x EC-> 4 x Doc. Plan B PI: Dr. M. Hellriegel contact: Dr. M. Hellriegel A phase III multicenter double blind randomized trial of celecoxib versus placebo in primary breast cancer patients (REACT-Randomised European Celecoxib Trial) An international multi-centre study of tamoxifen vs anastrozole in postmenopausal women with Ductal Carcinoma in Situ (IBIS-DCIS) PI: Prof. Dr. G. Emons 4

5 Ovariancancer ICON7/AGO Ovar 11 - A randomised, two-arm, multi-centre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer HECTOR (Hycamtin plus Carboplatin versus Established Regimens for the Treatment of Ovarian Cancer Relapse) A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have not Progressed after First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal. AGO-OVAR 16 AGO-OVAR LION-Study: Lymhadenectomy In Ovarian Neoplasms. Prospectiv randomized, multicentral Study to assess the efficacy of systematic pelvic and paraaortic lymphadenectomy in patients with advanced ovarian cancer and intraabdominal complete debulking. 5

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