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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00550771 |
The purpose of this study is to compare the incidence of cardiac dysfunction in subjects with HER2 positive breast cancer treated with either doxorubicin or pegylated liposomal doxorubicin (PLD), both in combination with trastuzumab.
Condition | Intervention | Phase |
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Breast Neoplasm |
Drug: doxorubicin, cyclophosphamide, paclitaxel, trastuzumab Drug: PLD, cyclophosphamide, trastuzumab, paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Randomized Phase II Multinational Trial to Evaluate the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer: Caelyx + Cyclophosphamide + Trastuzumab (C+C+H) or Doxorubicin + Cyclophosphamide (A+C), Each Followed by Paclitaxel + Trastuzumab (T+H) BACH |
Estimated Enrollment: | 180 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Active Comparator
doxorubicin 60 mg/m2 IV push + cyclophosphamide 600 mg/m2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
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Drug: doxorubicin, cyclophosphamide, paclitaxel, trastuzumab
doxorubicin 60 mg/m2 IV push + cyclophosphamide 600 mg/m2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
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Arm B: Experimental
PLD 35 mg/m2 IV over 60 minutes + cyclophosphamide 600 mg/m2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
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Drug: PLD, cyclophosphamide, trastuzumab, paclitaxel
PLD 35 mg/m2 IV over 60 minutes + cyclophosphamide 600 mg/m2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects with operable, node-positive or high-risk node-negative (see #3 below) HER2-positive breast carcinoma are eligible for the study, provided they satisfy the following criteria.
3. Subjects must have been diagnosed with operable, histologically confirmed adenocarcinoma of the breast with no clinical or radiological evidence of metastatic disease but with otherwise high or intermediate risk tumor characteristics:
node-negative AND at least one of the following features:
Tumor >1 cm and
Exclusion Criteria:
Subject who meets any of the following exclusion criteria will be disqualified from participation in the study:
Serious cardiac illness including, but not confined to
Any of the following clinical conditions:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
Australia | |
Investigational Site 1 | Recruiting |
Parkville, Australia, 3050 | |
Investigational Site 64 | Recruiting |
Box Hill, Australia, 3128 | |
Belgium | |
Investigational Site 5 | Recruiting |
Charleroi, Belgium, 6000 | |
Canada | |
Investigational Site 9 | Recruiting |
Quebec, Canada, G1S 4L8 | |
Investigational Site 8 | Recruiting |
Halifax, Canada, B3H 2Y9 | |
Italy | |
Investigational Site 18 | Recruiting |
Messina, Italy, 98125 | |
Investigational Site 15 | Recruiting |
Roma, Italy, 00168 | |
Investigational Site 16 | Recruiting |
Campobasso, Italy, 86100 | |
Netherlands | |
Investigational Site 48 | Recruiting |
Apeldoorn, Netherlands, 7334 DZ | |
Investigational Site 42 | Recruiting |
Emmen, Netherlands, 7824 AA | |
Investigational Site 44 | Recruiting |
Almere, Netherlands, 1315 RA | |
Investigational Site 46 | Recruiting |
Dordrecht, Netherlands, 3318 AT | |
Investigational Site 47 | Recruiting |
Goes, Netherlands, 4462 RA | |
Investigational Site 49 | Recruiting |
S Gravenhage, Netherlands, 2545 CH | |
Investigational Site 56 | Recruiting |
Breda, Netherlands, 4819 EV | |
Investigational Site 40 | Recruiting |
Utrecht, Netherlands, 3527 CE | |
Investigational Site 50 | Recruiting |
Rotterdam, Netherlands, 3078 HT | |
Investigational Site 54 | Recruiting |
Schiedam, Netherlands, 3116BA | |
Investigational Site 59 | Recruiting |
Alkmaar, Netherlands, 1814 JD | |
Investigational Site 39 | Recruiting |
S Hertogenbosch, Netherlands, 5211 NL | |
Investigational Site 53 | Recruiting |
Hengelo, Netherlands, 7555 DL | |
Investigational Site 45 | Recruiting |
Capelle aan de IJssel, Netherlands, 2906 ZC | |
Investigational Site 51 | Completed |
Enschede, Netherlands, 7511 JX | |
Investigational Site 41 | Recruiting |
Amsterdam, Netherlands, 1105 AZ | |
Investigational Site 55 | Recruiting |
Amstelveen, Netherlands, 1186 AM | |
Investigational site 67 | Recruiting |
Harderwijk, Netherlands, 3844 DG | |
Spain | |
Investigational Site 31 | Recruiting |
Valencia, Spain, 46010 | |
Investigational Site 32 | Recruiting |
Madrid, Spain, 28034 | |
Investigational Site 33 | Recruiting |
Cruces-Baracaldo, Spain, 48903 | |
Investigational Site 35 | Recruiting |
Pontevedra, Spain, 36002 | |
Switzerland | |
Investigational Site 37 | Recruiting |
Zurich, Switzerland, CH-8091 | |
Investigational Site 38 | Recruiting |
Aarau, Switzerland, 5001 |
Study Chair: | Shanna Stopatschinskaja | Essex Chemie AG |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05048 |
Study First Received: | October 29, 2007 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00550771 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Skin Diseases Paclitaxel Trastuzumab Breast Neoplasms |
Cyclophosphamide Doxorubicin Breast Diseases |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |