- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04031703
Study Comparing Paclitaxel Plus Carboplatin Versus Anthracyclines Followed by Docetaxel as Adjuvant Chemotherapy for Triple Negative Breast Cancer (PATTERN)
April 21, 2020 updated by: Zhimin Shao, Fudan University
Study Comparing Paclitaxel Plus Carboplatin Versus Anthracyclines Followed by Docetaxel as Adjuvant Chemotherapy for Triple Negative Breast Cancer
This is a prospective, multisite, randomized, open-lable Phase III clinical trial (PATTERN study) comparing Paclitaxel Plus Carboplatin versus Anthracyclines followed by docetaxel as adjuvant chemotherapy for triple negative breast cancer
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
647
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women aged 18-65 years old;
- Patient has localized invasive breast carcinoma, and is ER-/PR-/HER2- confirmed by histopathology after early breast cancer surgery(HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver in situ hybridization (SISH)) test is required by local laboratory testing.), positive lymph node or negative lymph node with at least one of the following conditions: (1) histological grade II or III; (2) tumor size > 0.5
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN,and with endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula).
- Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.
Exclusion Criteria:
- Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy);
- Has bilateral breast cancer;
- Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
- Has metastic (Stage 4) breast cancer;
- Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);
- Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
- Patients participating in other clinical trials at the same time;
- Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
- Has known allergy to taxane and excipients.
- Has severe or uncontrolled infection;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 6 cycles of PC adjuvant chemotherapy
6 cycles of PC (Paclitaxel 80 mg/m2 ivgtt d1,8,15+ Carboplatin Auc = 2 ivgtt d1,8,15, 28 days per cycle).
|
Paclitaxel chemotherapy (injection)
Carboplatin chemotherapy (injection)
|
Active Comparator: 3 cycles of FEC followed by 3 cycles of Docetaxel
3 cycles of FEC (epirubicin100 mg/m2 ivgtt d1+Cyclophosphamide 500 mg/m2 iv d1+ 5-fluorouracil 500 mg/m2 iv d1, 21 days per cycle) followed by 3 cycles of Docetaxel (Docetaxel 100mg/m2, ivgtt d1, 21 days per cycle)
|
Docetaxel chemotherapy (injection)
Cyclophosphamide chemotherapy (injection)
Epirubicin chemotherapy (injection)
5-fluorouracil chemotherapy (injection)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease free survival
Time Frame: 5 year
|
5 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 5 year
|
5 year
|
distant metastasis free survival
Time Frame: 5 year
|
5 year
|
event free survival
Time Frame: 5 year
|
5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zhi-Ming Shao, Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
April 20, 2016
Study Completion (Actual)
April 20, 2016
Study Registration Dates
First Submitted
July 22, 2019
First Submitted That Met QC Criteria
July 22, 2019
First Posted (Actual)
July 24, 2019
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 21, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Triple Negative Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Docetaxel
- Cyclophosphamide
- Carboplatin
- Paclitaxel
- Fluorouracil
- Epirubicin
Other Study ID Numbers
- PATTERN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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