Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer

NCT ID: NCT02207361

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

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-12-31

Brief Summary

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Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Detailed Description

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A Randomized Prospective Clinical Trial of Paclitaxel in Combination with Carboplatin Versus Paclitaxel plus Epirubicin as First-Line Treatment in 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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Metastatic Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paclitaxel, Carboplatin,injection

Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.

Group Type EXPERIMENTAL

Paclitaxel, Carboplatin

Intervention Type DRUG

Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.

Paclitaxel, Epirubicin,injection

Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.

Group Type ACTIVE_COMPARATOR

Paclitaxel, Epirubicin

Intervention Type DRUG

Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.

Interventions

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Paclitaxel, Carboplatin

Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.

Intervention Type DRUG

Paclitaxel, Epirubicin

Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* female ≥ 18 years old, ECOG 0-2 or KPS≥60, Expected lifetime more than 12 weeks.

Exclusion Criteria

* Pregnancy, Paclitaxel, platinum and anthracycline-based drugs' allergy, Severe Infection.
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

Principal Investigators

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Zhongsheng Tong, Master

Role: STUDY_DIRECTOR

Tianjin Medical University Cancer Institute and Hospital

Locations

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhongsheng Tong, Master

Role: CONTACT

Phone: +86 18622221181

Email: [email protected]

Facility Contacts

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Zhongsheng Tong, Master

Role: primary

References

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Egger SJ, Chan MMK, Luo Q, Wilcken N. Platinum-containing regimens for triple-negative metastatic breast cancer. Cochrane Database Syst Rev. 2020 Oct 21;10(10):CD013750. doi: 10.1002/14651858.CD013750.

Reference Type DERIVED
PMID: 33084020 (View on PubMed)

Other Identifiers

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CIH-TZS-20140421-02

Identifier Type: -

Identifier Source: org_study_id