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Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT02897050
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary:
This multi-center, open-label, phase II randomized controlled trial is to evaluate the efficacy of docetaxel(T) combined with metronomic cyclophosphamide/capecitabine (mCX) followed by fluorouracil /epirubicin/cyclophosphamide (FEC) versus T followed by FEC as neoadjuvant chemotherapy in treating women with triple negative breast cancer (TNBC), and to study the anti-tumor immune effect of metronomic neoadjuvant chemotherapy. 186 stage M0 TNBC patients who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging are randomly enrolled to receive neoadjuvant T combined with mCX (3 cycles) followed by FEC (3 cycles) or T (3cycles) followed by FEC (3 cycles) before surgery. The primary end point is pathological complete response (pCR) rate, and the secondary end points include: clinical response rate, toxicities, breast-conserving rate, Ki67 and CD31 reduction rate, changes in the percentages of peripheral blood or tumor microenvironmental regulatory T cells (Treg), T helper cells (Th), CD8+ T cell, and tumor-specific CTL, and changes in tumor microenvironmental immune cytokines. Once there is a significant statistical difference in terms of pCR rate between two groups, 3-year disease-free survival (DFS) and 3-year overall survival (OS) will be included in the secondary end points. The aims of this study are to determine whether the neoadjuvant T combined with metronomic CX followed by FEC can significantly increase the pCR rate in TNBC with acceptable toxicity, and to explore the anti-tumor immune effect of metronomic neoadjuvant chemotherapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Drug: Capecitabine Drug: Cyclophosphamide (tablet) Drug: Fluorouracil Drug: Epirubicin Drug: Cyclophosphamide (injection) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: T+mCX followed by FEC
Docetaxel 75mg/m2, iv, d1 + CTX 50 mg/d, po, d1-d21 + capecitabine 1200mg/m2/d, po, d1-d21 * 3 cycles (21 days per cycle) followed by fluorouracil 500mg/m2,iv,d1 + epirubicin 100mg/m2,iv,d1 + cyclophosphamide 500mg/m2,iv,d1 * 3 cycles (21 days per cycle)
Drug: Docetaxel
Docetaxel 75mg/m2, iv, d1 or 100mg/m2, iv, d1

Drug: Capecitabine
Capecitabine 1200mg/m2/d, po, d1-d21
Other Name: Xeloda

Drug: Cyclophosphamide (tablet)
Cyclophosphamide 50 mg/d, po, d1-d21
Other Name: CTX

Drug: Fluorouracil
Fluorouracil 500mg/m2, iv, d1
Other Name: 5-Fu

Drug: Epirubicin
Epirubicin 100mg/m2, iv, d1

Drug: Cyclophosphamide (injection)
Cyclophosphamide 500mg/m2, iv, d1
Other Name: CTX

Active Comparator: T followed by FEC
Docetaxel 100mg/m2, iv, d1 * 3 cycles (21 days per cycle) followed by fluorouracil 500mg/m2,iv,d1 + epirubicin 100mg/m2,iv,d1 + cyclophosphamide 500mg/m2,iv,d1 * 3 cycles (21 days per cycle)
Drug: Docetaxel
Docetaxel 75mg/m2, iv, d1 or 100mg/m2, iv, d1

Drug: Fluorouracil
Fluorouracil 500mg/m2, iv, d1
Other Name: 5-Fu

Drug: Epirubicin
Epirubicin 100mg/m2, iv, d1

Drug: Cyclophosphamide (injection)
Cyclophosphamide 500mg/m2, iv, d1
Other Name: CTX




Primary Outcome Measures :
  1. Pathological complete response (pCR) rate [ Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication) ]

Secondary Outcome Measures :
  1. Ultrasound response rate [ Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication) ]
  2. Breast-conserving surgery rate [ Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication) ]
  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: during on-neoadjuvant therapy period (defined as the period from the first dose of study medication up to 30 days of the last dose) ]
  4. Tumor Ki67 reduction rate in relation to neoadjuvant therapy [ Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication) ]
  5. Tumor CD31 reduction rate in relation to neoadjuvant therapy [ Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication) ]
  6. Peripheral blood CD8+ T cell percentage change in relation to neoadjuvant therapy [ Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication) ]
  7. Peripheral blood regulatory T cell percentage change in relation to neoadjuvant therapy [ Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication) ]
  8. Peripheral blood tumor specific T cell (CTL) percentage change in relation to neoadjuvant therapy [ Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication) ]
  9. Peripheral blood T helper cell percentage change in relation to neoadjuvant therapy [ Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication) ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients signed the written informed consent
  • The patients present with non-metastatic unilateral invasive ER-negative (IHC<10%), PR-negative(IHC<10%), HER2-negative breast cancer with a primary breast tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging.
  • 18 years old< age < 70 years old.
  • The patients have no history of hormone therapy, chemotherapy, breast cancer surgery and radiotherapy.
  • The patients have normal cardiac functions by echocardiography.
  • The patients' ECOG scores are ≤2.
  • The patients can swallow pills.
  • The results of patients' blood tests are as follows:

    • Hb≥90g/L;
    • WBC≥4E+9/L;
    • Plt≥100E+9/L;
    • Neutrophils≥1.5E+9/L;
    • ALT and AST ≤ triple of normal upper limit;
    • TBIL ≤ 1.5 times of normal upper limit;
    • Creatinine ≤ 1.5 times of normal upper limit.

Exclusion Criteria:

  • The patients have other cancers at the same time or have the history of other cancers except controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix uterus;
  • The patients have active infections that were not suitable for chemotherapy;
  • The patients have severe non-cancerous diseases.
  • The patients have bilateral breast cancers or male breast cancers or inflammatory breast cancers.
  • The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials.
  • The patients are in some special conditions that they cannot understand the written informed consent, such as they are demented or hawkish.
  • The patients have allergic history or contraindication of any of the interventional drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897050


Contacts
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Contact: Erwei Song songew@mail.sysu.edu.cn
Contact: Jieqiong Liu liujieqiong01@163.com

Locations
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China, Guangdong
Sun Yat-sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Erwei Song       songew@mail.sysu.edu.cn   
Contact: Jieqiong Liu       liujieqiong01@163.com   
Peking University Shenzhen Hospital Recruiting
Shenzhen, Guangdong, China
Contact: Wei Wei, M.D.,Ph.D.    86-13600405191    rxwei1123@163.com   
China, Hunan
Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China
Contact: Enxiang Zhou, M.D.    86-13548636806    zhouenxiang@medmail.com.cn   
China, Xinjiang
Xinjiang Medical School Cancer Hospital Not yet recruiting
Urumqi, Xinjiang, China, 830000
Contact: Binlin Ma, M.D.    86-13809951599    mbldoctor@126.com   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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Responsible Party: Erwei Song, M.D., Ph.D., President of Sun Yat-sen Memorial Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02897050    
Other Study ID Numbers: BCCT2016001
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Capecitabine
Fluorouracil
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antimetabolites, Antineoplastic
Antimetabolites
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors