Study Comparing Paclitaxel Plus Carboplatin Versus Anthracyclines Followed by Docetaxel as Adjuvant Chemotherapy for Triple Negative Breast Cancer (PATTERN)

NCT04031703 | Completed Phase 3 DMC

• 1 other identifier: PATTERN
• Study Type: interventional
• Target: 647
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  5 year

Secondary Outcomes (3)

• distant metastasis free survival

  5 year

• event free survival

  5 year

• overall survival

  5 year

Study Arms (2)

6 cycles of PC adjuvant chemotherapy

EXPERIMENTAL

6 cycles of PC (Paclitaxel 80 mg/m2 ivgtt d1,8,15+ Carboplatin Auc = 2 ivgtt d1,8,15, 28 days per cycle).

Drug: Paclitaxel; Drug: Carboplatin

3 cycles of FEC followed by 3 cycles of Docetaxel

ACTIVE COMPARATOR

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)

Drug: Epirubicin; Drug: Cyclophosphamide; Drug: 5-fluorouracil; Drug: Docetaxel

Interventions

Paclitaxel DRUG

Paclitaxel chemotherapy (injection)

6 cycles of PC adjuvant chemotherapy

Carboplatin DRUG

Carboplatin chemotherapy (injection)

6 cycles of PC adjuvant chemotherapy

Epirubicin DRUG

Epirubicin chemotherapy (injection)

3 cycles of FEC followed by 3 cycles of Docetaxel

Cyclophosphamide DRUG

Cyclophosphamide chemotherapy (injection)

3 cycles of FEC followed by 3 cycles of Docetaxel

5-fluorouracil DRUG

5-fluorouracil chemotherapy (injection)

3 cycles of FEC followed by 3 cycles of Docetaxel

Docetaxel DRUG

Docetaxel chemotherapy (injection)

3 cycles of FEC followed by 3 cycles of Docetaxel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Carboplatin; Epirubicin; Cyclophosphamide; Fluorouracil; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zhi-Ming Shao

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Arm 1：6 cycles of PC (Paclitaxel 80 mg/m2 ivgtt d1,8,15+ Carboplatin Auc = 2 ivgtt d1,8,15, 28 days per cycle). Arm 2：3 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)

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 24, 2019
• Study Start: January 1, 2011
• Primary Completion: April 20, 2016
• Study Completion: April 20, 2016
• Last Updated: April 24, 2020

Record last verified: 2020-03