Neoadjuvant Trial of Capecitabine for Axillary Lymph Node Positive Operable Breast Cancer

NCT ID: NCT02115152

Last Updated: 2014-04-15

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

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Brief Summary

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This randomized phase II trial compared pathologic response rates (pCR) of early breast cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and capecitabine-epirubicin-cyclophosphamide (XEC).

Detailed Description

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Conditions

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Stage II Breast Cancer Stage III Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FEC

Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery.

Group Type ACTIVE_COMPARATOR

fluorouracil

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

XEC

Patients will be randomized to received 4 cycles of capecitabine, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel and capecitabine after surgery.

Group Type EXPERIMENTAL

capecitabine

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Interventions

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fluorouracil

Intervention Type DRUG

capecitabine

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females aged 18-70 with histologically proven, core-biopsied, Stage II-III invasive breast cancer
* No distant disease

Exclusion Criteria

\- Inadequate heart or liver or kidney function
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Guangxi Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jianlun Liu

Director of Department of Breast Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianlun Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Guangxi Medical University Cancer Center

Locations

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Breast Cancer Surgery Department of Guangxi Medical University Cancer Center

Nanning, Guangxi, China

Site Status

Countries

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China

Central Contacts

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Jianlun Liu

Role: CONTACT

Facility Contacts

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Jianlun Liu, MD

Role: primary

Other Identifiers

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JLiu

Identifier Type: -

Identifier Source: org_study_id

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