Clinical trial NCT01479036: Trial of Neoadjuvant Endostar, Docetaxel and Epirubicin for Patients With Breast Cancer
Official title: Phase Ⅲ Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-Line Therapy in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast cancer
neoadjuvant chemotherapy
recombinant human endostatin (endostar)
docetaxel
epirubicin
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
* Stage ⅡA-ⅢC
* Age 18-70
* ECOG performance status 0-2
* No evidence of distant metastasis
* No previous therapy
* Normal hematologic function
* left ventricular ejection fraction greater than 50 percent
* No abnormality of renal or liver function
* Written informed consent

Exclusion Criteria:

* With allergic constitution or possible allergic reflection to drugs to be used in this study
* Any concurrent uncontrolled medical or psychiatric disorder
* History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease.
* History of bleeding diathesis
* Being pregnant or nursing

Primary outcomes:
measure: Clinical/pathological response
timeFrame: 3 years
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 3 years
measure: Quality of life
timeFrame: 3 years
measure: Number of adverse events reported during neoadjuvant therapy
timeFrame: 3 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Jianghao Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xijing Hospital
name: Ling Wang, MD
role: STUDY_DIRECTOR
References:
citation: In our previous phase Ⅱ trial (NCT00604435), the combination of rh-endostatin with docetaxel and epirubicin chemotherapy resulted in a higher objective response rate without increased toxicity in breast cancer patients, as compared with chemotherapy alone. Our results have been accepted to report as General Poster in ASCO's 47th Annual Meeting in 2011. Wang L, Chen JH, Yao Q, et al. Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study. 2011 ASCO Annual Meeting Proceedings, J Clin Oncol 2011; 29(15s): 112s.
citation: Chen J, Yao Q, Huang M, Wang B, Zhang J, Wang T, Ming Y, Zhou X, Jia Q, Huan Y, Wang J, Wang L. A randomized Phase III trial of neoadjuvant recombinant human endostatin, docetaxel and epirubicin as first-line therapy for patients with breast cancer (CBCRT01). Int J Cancer. 2018 May 15;142(10):2130-2138. doi: 10.1002/ijc.31217. Epub 2017 Dec 23.