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Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer

NCT ID: NCT02207335

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

PHASE3

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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Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Detailed Description

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A multicenter randomized phase Ⅲ clinical trial of gemcitabine in combination with capecitabine versus gemcitabine plus carboplatin as first-line treatment in triple-negative recurrent or 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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Gemcitabine，Capecitabine

Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14

Group Type EXPERIMENTAL

Gemcitabine，Capecitabine

Intervention Type DRUG

Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14

Gemcitabine, Carboplatin

Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8

Group Type ACTIVE_COMPARATOR

Gemcitabine, Carboplatin

Intervention Type DRUG

Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8

Interventions

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Gemcitabine，Capecitabine

Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14

Intervention Type DRUG

Gemcitabine, Carboplatin

Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female
* 18-70 years old
* ECOG 0-1
* Expected lifetime more than 12 weeks

Exclusion Criteria

* Pregnancy
* Brain Metastasis,
* Severe Infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Liu X, Zhao W, Jia Y, Shi Y, Wang X, Li S, Zhang P, Wang C, Hao C, Tong Z. A non-inferiority, phase III trial of gemcitabine plus capecitabine versus gemcitabine plus carboplatin as first-line therapy and tumor-infiltrating lymphocytes as a prognostic biomarker in patients with advanced triple-negative breast cancer. Ther Adv Med Oncol. 2024 Dec 3;16:17588359241240304. doi: 10.1177/17588359241240304. eCollection 2024.

Reference Type DERIVED
PMID: 39634173 (View on PubMed)

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-20140421-01

Identifier Type: -

Identifier Source: org_study_id