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

Last updated: November 12, 2023
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

3

Condition

Breast Cancer

Cancer

Treatment

Docetaxel

Cyclophosphamide

Clinical Study ID

NCT03926091
CLOVER
  • Ages 18-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. women aged 18-70 years old;
  2. Patient has localized invasive breast carcinoma with1-3 positive lymph nodes, and isER+/HER2- confirmed by histopathology after early breast cancer surgery(HER2-negativebreast cancer (based on most recently analyzed biopsy) defined as a negative in situhybridization 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 followingconditions: (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;
  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 marrowfunction: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absoluteneutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver andkidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN),Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serumcreatinine ≤ 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 anytrial related activities are conducted, has good compliance and has agreed tofollow-up.

Exclusion

Exclusion Criteria:

  1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapyor endocrine therapy);
  2. Has bilateral breast cancer;
  3. Has previous history of additional malignancy, with the exception of adequatelytreated basal cell carcinoma and cervical carcinoma in situ.
  4. Has metastatic (Stage 4) breast cancer;
  5. Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, andinflammatory breast cancer);
  6. Is pregnant, is breast feeding women, or women of childbearing age who cannot practiceeffective contraceptives;
  7. Patients participating in other clinical trials at the same time;
  8. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, leftventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardiocerebral vascular disease within the 6 months previous of randomization (such asunstable angina, chronic heart failure, uncontrolled hypertension with bloodpressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabeticpatients with poor blood glucose control; patients with severe hypertension;
  9. Has known allergy to taxane and excipients.
  10. Has severe or uncontrolled infection;
  11. Has a history of psychotropic substance abuse and were unable to abandon drug habits,or those with history of mental disorders;
  12. the researchers judged patients to be unsuitable for the study.

Study Design

Total Participants: 2172
Treatment Group(s): 2
Primary Treatment: Docetaxel
Phase: 3
Study Start date:
April 01, 2019
Estimated Completion Date:
November 01, 2025

Study Description

While TC (docetaxel+cyclophosphamide) adjuvant chemotherapy is one of the preferred regimens for early breast cancer, we have yet to determine the optimum number of cycles for TC adjuvant chemotherapy. In this prospective, open-label clinical trial, estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer patients with 1-3 positive lymph nodes will be randomized into either 4 cycles or 6 cycles of TC adjuvant chemotherapy. The safety and efficacy of each group will be assessed through disease-free survival (DFS), invasive disease free survival (iDFS), distant disease free survival (DDFS), overall survival (OS) and adverse effects (AE) as graded by Common Terminology Criteria for Adverse Events (CTCAE) 4.0.

Connect with a study center

  • Chongqing Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

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

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150081
    China

    Active - Recruiting

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

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning 116027
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266000
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Hospital

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • OB/GYN Hospital of Fudan University

    Shanghai, Shanghai 200011
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

  • The First Affiliated Hospital, ZheJiang University

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hanzhou, Zhejiang 310009
    China

    Active - Recruiting

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