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Adjuvant Platinum and Taxane in Triple-negative Breast Cancer (PATTERN)

NCT01216111 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 647

Last updated 2020-05-19

No results posted yet for this study

Summary

Previous studies in Western country show that triple-negative breast cancer has aggressive clinical and pathological features compared with non-triple negative breast cancer, including onset at a young age, advanced clinical stage, high histologic and nuclear grade and more distant recurrence.

According to the characteristics of triple negative breast tumor, the TNBC patients can benefit neither from hormonal therapies nor from target therapies against Her2 receptors. The only systemic therapy currently available is chemotherapy, and prognosis remains poor. It becomes more and more important to investigate the sensitive chemotherapy regimen for triple negative patients.

Cisplatin-based regimen was active for the patients of lung cancer, colorectal cancer and ect. Triple negative breast cancer patients were more sensitive to platinum-based chemotherapy regimens according to the results of some retrospective studies.

The investigators hypothesized that paclitaxel combined with cisplatin is more sensitive to triple negative breast cancer compared with CEF followed by docetaxel.

Conditions

Interventions

DRUG

Paclitaxel Cisplatin

Paclitaxel 80 mg/m2 D1，8，15 Cisplatin AUC=2 D1，8，15 1 cycle = 28days PC\*6

DRUG

fluorouracil epirubicin cyclophosphamide and docetaxel (FEC-T)

fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 intravenously on day 1 every 21 days for three cycles followed by docetaxel 100 mg/m2 intravenously

Sponsors & Collaborators

  • Chinese Anti-Cancer Association

    collaborator OTHER

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-01
Primary Completion
2016-04-20
Completion
2016-04-20

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01216111 on ClinicalTrials.gov