Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer

NCT ID: NCT01635465

Last Updated: 2015-12-22

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

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2016-12-31

Brief Summary

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Docetaxel plus Capecitabine in anthracycline-pretreated metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Vinorelbine plus Capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Detailed Description

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A randomised controlled trial of vinorelbine plus capecitabine versus docetaxel plus capecitabine in anthracycline-pretreated women with metastatic breast cancer. The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Conditions

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Anthracycline-pretreated Metastatic Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation group:vinorelbine plus capecitabine

No interventions assigned to this group

Control group:docetaxel plus capecitabine

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* female ≥ 18 years old ECOG 0-2

Exclusion Criteria

* brain metastasis
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Central Contacts

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Li shufen, bachelor

Role: CONTACT

Phone: 022-23340123-1052

Email: [email protected]

Facility Contacts

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Li Shufen, bachelor

Role: primary

References

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Li S, Meng W, Zhang J, Xie X, Hao C, Jia Y, Tong Z. A randomized controlled Phase II trial of vinorelbine plus capecitabine versus docetaxel plus capecitabine in anthracycline-pretreated women with metastatic breast cancer. J Cancer Res Ther. 2020 Sep;16(5):1069-1076. doi: 10.4103/jcrt.JCRT_792_19.

Reference Type DERIVED
PMID: 33004749 (View on PubMed)

Other Identifiers

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CIH-LSF-201205001

Identifier Type: -

Identifier Source: org_study_id