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

NCT ID: NCT01479036

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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breast cancer neoadjuvant chemotherapy recombinant human endostatin (endostar) docetaxel epirubicin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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docetaxel and epirubicin

DE chemotherapy alone

Group Type ACTIVE_COMPARATOR

docetaxel and epirubicin

Intervention Type DRUG

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 plus endostatin

chemotherapy plus endostatin

Group Type EXPERIMENTAL

docetaxel and epirubicin plus endostatin

Intervention Type DRUG

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

Interventions

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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, totally 3 cycles

Intervention Type DRUG

docetaxel and epirubicin plus endostatin

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

Intervention Type DRUG

Other Intervention Names

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Docetaxel, Sanofi-Aventis Epirubicin, Pfizer Endostatin, Simcere-Medgenn (No. S20050088)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianghao Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Ling Wang, MD

Role: STUDY_DIRECTOR

Xijing Hospital

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianghao Chen, MD, PhD

Role: CONTACT

Phone: 86-29-84775271

Email: [email protected]

Qing Yao, MD

Role: CONTACT

Phone: 86-29-84775271

Email: [email protected]

Facility Contacts

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Aidong Wen, MD

Role: primary

References

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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.

Reference Type BACKGROUND

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.

Reference Type DERIVED
PMID: 29238974 (View on PubMed)

Other Identifiers

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CBCRT01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Endostar B-02

Identifier Type: -

Identifier Source: org_study_id