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Sponsored by: |
Xijing Hospital |
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Information provided by: | Xijing Hospital |
ClinicalTrials.gov Identifier: | NCT00604435 |
This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy to chemotherapy could further enhance the cytotoxic activity in breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: docetaxel and epirubicin Drug: docetaxel and epirubicin plus endostatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-Line Therapy in Patients With Breast Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
neoadjuvant therapy with 3 cycles of DE
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Drug: docetaxel and epirubicin
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, totally 3 cycles
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2: Experimental
neoadjuvant therapy with 3 cycles of DE and endostatin
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Drug: docetaxel and epirubicin plus endostatin
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostatin 7.5mg/m2, IV (in the vein) on 1st to 14th days of each 21 day cycle; every 3 weeks, totally 3 cycles
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This is an open labelled, prospective, randomized, phase II clinical trial. A total of 60 patients with core-biopsy confirmed breast cancer, stage ⅡA to ⅢC, and to be treated with neoadjuvant systemic therapy are eligible for entry into this study. Patients will be allocated randomly to two groups to receive either 3 cycles of neoadjuvant DE and endostar or 3 cycles of neoadjuvant DE. All cases receive mammography, contrast-enhanced ultrasound (CEUS), magnetic resonance angiography (MRA), and positron emission tomography (PET) scanning pre- and post-neoadjuvant therapy, and then undergo surgical resection. The primary endpoint is clinical/pathological response. The secondary endpoint is (1) the safety and tolerability of the regimens, (2) the role of mammography, CEUS, MRA and PET for response evaluation, and (3) angiogenic profile and biological information involved in tumor response.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jianghao Chen, MD, PhD | 86-29-84775271 | chenjh@fmmu.edu.cn |
Contact: Qing Yao, MD | 86-29-84775267 | huanhuan@fmmu.edu.cn |
China, Shaanxi | |
Xijing Hospital, Fourth Military Medical University | Recruiting |
Xi'an, Shaanxi, China, 710032 | |
Contact: Jianghao Chen, MD, PhD 86-29-84775271 chenjh@fmmu.edu.cn | |
Contact: Qing Yao, MD 86-29-84775267 huanhuan@fmmu.edu.cn | |
Sub-Investigator: Dong Li, MD | |
Sub-Investigator: Ting Wang, MD | |
Sub-Investigator: Juliang Zhang, MD | |
Xijing Hospital, Fourth Military Medical University | Recruiting |
Xi'an, Shaanxi, China, 710032 | |
Contact: Jianghao Chen, MD, PhD 86-29-84775271 chenjh@fmmu.edu.cn | |
Principal Investigator: Jianghao Chen, MD, PhD | |
Principal Investigator: Ling Wang, MD |
Study Director: | Ling Wang, MD | Xijing Hospital, Fourth Military Medical University |
Study Chair: | Jianghao Chen, MD, PhD | Xijing Hospital, Fourth Military Medical University |
Responsible Party: | Fourth Military Medical University ( Dai-Ming Fan, Principal of Fourth Military Medical University ) |
Study ID Numbers: | Endostar B-01, XOBCR01 |
Study First Received: | January 16, 2008 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00604435 |
Health Authority: | China: State Food and Drug Administration |
breast cancer neoadjuvant chemotherapy docetaxel epirubicin |
recombinant human endostatin (endostar) chemotherapy endostatin |
Docetaxel Skin Diseases Breast Neoplasms |
Endostatins Epirubicin Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Antibiotics, Antineoplastic Angiogenesis Inhibitors Pharmacologic Actions |