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

NCT ID: NCT04031703

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 647 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2016-04-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Paclitaxel chemotherapy (injection)

Carboplatin

Intervention Type: DRUG

Carboplatin chemotherapy (injection)

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)

Group Type: ACTIVE_COMPARATOR

Epirubicin

Intervention Type: DRUG

Epirubicin chemotherapy (injection)

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide chemotherapy (injection)

5-fluorouracil

Intervention Type: DRUG

5-fluorouracil chemotherapy (injection)

Docetaxel

Intervention Type: DRUG

Docetaxel chemotherapy (injection)

Interventions

Paclitaxel

Paclitaxel chemotherapy (injection)

Intervention Type: DRUG

Carboplatin

Carboplatin chemotherapy (injection)

Intervention Type: DRUG

Epirubicin

Epirubicin chemotherapy (injection)

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide chemotherapy (injection)

Intervention Type: DRUG

5-fluorouracil

5-fluorouracil chemotherapy (injection)

Intervention Type: DRUG

Docetaxel

Docetaxel chemotherapy (injection)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. women aged 18-65 years old;

2. 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

3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

4. 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).

5. 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

1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy）;

2. Has bilateral breast cancer;

3. Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.

4. Has metastic (Stage 4) breast cancer;

5. Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);

6. Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;

7. Patients participating in other clinical trials at the same time;

8. 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;

9. Has known allergy to taxane and excipients.

10. Has severe or uncontrolled infection;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhi-Ming Shao

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Other Identifiers

PATTERN

Identifier Type: -

Identifier Source: org_study_id