Study Comparing 4 Cycles With 6 Cycles of TC (Docetaxel+Cyclophosphamide) Adjuvant Chemotherapy for 1-3 Lymph Node Positive ER+/HER2- Early Breast Cancer

NCT03926091 | Unknown Phase 3 DMC

• 1 other identifier: CLOVER
• Study Type: interventional
• Target: 2,172
• Locations: 1 country
• Sites: 14

Brief Summary

This is a prospective, multisite, randomized, open-label Phase III clinical trial (CLOVER study) comparing 4 cycles with 6 cycles of TC (docetaxel+cyclophosphamide) adjuvant chemotherapy for 1-3 positive lymph node, ER+/HER2- early breast cancer patients.

Conditions

Breast Cancer

Keywords

docetaxel; cyclophosphamide; adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Invasive disease free survival

  5 year

Secondary Outcomes (4)

• disease free survival

  5 years

• distant disease free survival

  5 years

• overall survival

  5 years

• adverse effects

  5 years

Study Arms (2)

4 cycles of TC adjuvant chemotherapy

EXPERIMENTAL

4 cycles of TC (Docetaxel 75 mg/m\^2 ivgtt d1+Cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle).

Drug: Docetaxel; Drug: Cyclophosphamide

6 cycles of TC adjuvant chemotherapy

ACTIVE COMPARATOR

6 cycles of TC (Docetaxel 75 mg/m\^2 ivgtt d1+Cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle).

Drug: Docetaxel; Drug: Cyclophosphamide

Interventions

Docetaxel DRUG

Docetaxel chemotherapy (injection)

Also known as: docetaxel injection

4 cycles of TC adjuvant chemotherapy; 6 cycles of TC adjuvant chemotherapy

Cyclophosphamide DRUG

Cyclophosphamide chemotherapy (injection)

Also known as: Cyclophosphamide injection

4 cycles of TC adjuvant chemotherapy; 6 cycles of TC adjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women aged 18-70 years old;
• Patient has localized invasive breast carcinoma with1-3 positive lymph nodes, and is ER+/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.), with at least one of the following conditions: (1) histological grade III; (2) Ki67 ≥ 30%; (3) progesterone receptor (PR) ≤ 20% positive; (4) age less than 35 years; (5) extensive vascular tumor thrombus; (6) multigene detection recurrence score (RS) \>25;
• 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 metastatic (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;
• Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;
• the researchers judged patients to be unsuitable for the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (14)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Sun Yet-Sen Memorial Hospital, Sun Yet-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

The First Bethune Hospital of Jilin University (The First Hospital of Jilin University)

Changchun, Jilin, 130021, China

RECRUITING

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116027, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

OB/GYN Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Fudan University Shanghai Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

The First Affiliated Hospital, ZheJiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hanzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Cyclophosphamide

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Zhimin Shao, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao, MD, PhD

CONTACT

+86-021-64175590; zhimingshao@yahoo.com

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: Chief Physician

Model Details: Arm 1：6 cycles of TC (Docetaxel 75 mg/m\^2 ivgtt d1+Cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle). Arm 2：4 cycles of TC (Docetaxel 75 mg/m\^2 ivgtt d1+Cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle).

Study Record Dates

• First Submitted: March 31, 2019
• First Posted: April 24, 2019
• Study Start: April 1, 2019
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

CN (14)