Neoplasms

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Breast Neoplasms

Breast Diseases

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Docetaxel

Epirubicin

Endostar protein

Endostatins

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Enzyme Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, totally 3 cycles

docetaxel and epirubicin

docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 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

docetaxel and epirubicin plus endostatin

Jianghao Chen, MD, PhD

Qing Yao, MD

Aidong Wen, MD

Ling Wang, MD

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 benefit breast cancer patients.

This is a multicenter, prospective, randomized, controlled phase Ⅲ clinical trial. A total of 800 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 clinical response will be evaluated according to RECIST criteria. The parameters of tumor metabolism and blood supply, as demonstrated by PET, MRA and CEUS, will be collected and analysed. The secondary endpoint is (1) the number of participants with adverse events, (2) quality of life scores, and (3) the number of adverse events reported during neoadjuvant therapy. In addition, the role of mammography, CEUS, MRA and PET for response evaluation, as well as the angiogenic profile and biological information involved in tumor response will be investigated.

Trial of Neoadjuvant Endostar, Docetaxel and Epirubicin for Patients With Breast Cancer

Phase Ⅲ Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-Line Therapy in Patients With Breast Cancer

The clincial response will be evaluated according to RECIST criteria. The parameters of tumor metabolism and blood supply, as demonstrated by PET, MRA and CEUS, will be collected and analysed.

The number of participants with adverse events will be recorded and analysed.

Quality of life is scored using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Questionnaire (QLQ30) at study entry and prior to surgery.

The adverse events during neoadjuvant therapy will be graded using the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 2.0.

Xijing Hospital

neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin

neoadjuvant therapy with 3 cycles of 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, totally 3 cycles

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

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Neoadjuvant Endostar, Docetaxel and Epirubicin for Patients With Breast Cancer	NCT01479036	Breast Cancer	docetaxel and e... docetaxel and e...	18 Years - 70 Years	Xijing Hospital
Neoadjuvant Endostatin and Chemotherapy for Breast Cancer	NCT00604435	Breast Cancer	docetaxel and e... docetaxel and e...	18 Years - 70 Years	Xijing Hospital
Neoadjuvant Endostatin and Chemotherapy for Breast Cancer	NCT00604435	Breast Cancer	docetaxel and e... docetaxel and e...	18 Years - 70 Years	Xijing Hospital
Trial of Neoadjuvant Endostar, Docetaxel and Epirubicin for Patients With Breast Cancer	NCT01479036	Breast Cancer	docetaxel and e... docetaxel and e...	18 Years - 70 Years	Xijing Hospital

Spots Global Cancer Trial Database for docetaxel and epirubicin plus endostatin