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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031703
• Other study ID #: PATTERN
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2011
• Est. completion date: April 20, 2016

Study information

• Verified date: March 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 647
• Est. completion date: April 20, 2016
• Est. primary completion date: April 20, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Paclitaxel
Paclitaxel chemotherapy (injection)
• Carboplatin
Carboplatin chemotherapy (injection)
• Epirubicin
Epirubicin chemotherapy (injection)
• Cyclophosphamide
Cyclophosphamide chemotherapy (injection)
• 5-fluorouracil
5-fluorouracil chemotherapy (injection)
• Docetaxel
Docetaxel chemotherapy (injection)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		5 year
Secondary	distant metastasis free survival		5 year
Secondary	event free survival		5 year
Secondary	overall survival		5 year