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

Primary Purpose

Breast Cancer

Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Capecitabine
Cyclophosphamide (tablet)
Fluorouracil
Epirubicin
Cyclophosphamide (injection)
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yat-sen Memorial Hospital
  • Peking University Shenzhen Hospital
  • Second Xiangya Hospital of Central South University
  • Xinjiang Medical School Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

T+mCX followed by FEC

T followed by FEC

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Pathological complete response (pCR) rate

Secondary Outcome Measures

Ultrasound response rate
Breast-conserving surgery rate
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Tumor Ki67 reduction rate in relation to neoadjuvant therapy
Tumor CD31 reduction rate in relation to neoadjuvant therapy
Peripheral blood CD8+ T cell percentage change in relation to neoadjuvant therapy
Peripheral blood regulatory T cell percentage change in relation to neoadjuvant therapy
Peripheral blood tumor specific T cell (CTL) percentage change in relation to neoadjuvant therapy
Peripheral blood T helper cell percentage change in relation to neoadjuvant therapy

Full Information

First Posted
September 7, 2016
Last Updated
April 19, 2022
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02897050
Brief Title
Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer
Official Title
Phase II Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Suspended
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
T+mCX followed by FEC
Arm Type
Experimental
Arm Description
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)
Arm Title
T followed by FEC
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 75mg/m2, iv, d1 or 100mg/m2, iv, d1
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine 1200mg/m2/d, po, d1-d21
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide (tablet)
Other Intervention Name(s)
CTX
Intervention Description
Cyclophosphamide 50 mg/d, po, d1-d21
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
5-Fu
Intervention Description
Fluorouracil 500mg/m2, iv, d1
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
Epirubicin 100mg/m2, iv, d1
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide (injection)
Other Intervention Name(s)
CTX
Intervention Description
Cyclophosphamide 500mg/m2, iv, d1
Primary Outcome Measure Information:
Title
Pathological complete response (pCR) rate
Time Frame
at definitive surgery (20-24 weeks after the first dose of study medication)
Secondary Outcome Measure Information:
Title
Ultrasound response rate
Time Frame
at definitive surgery (20-24 weeks after the first dose of study medication)
Title
Breast-conserving surgery rate
Time Frame
at definitive surgery (20-24 weeks after the first dose of study medication)
Title
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)
Title
Tumor Ki67 reduction rate in relation to neoadjuvant therapy
Time Frame
at definitive surgery (20-24 weeks after the first dose of study medication)
Title
Tumor CD31 reduction rate in relation to neoadjuvant therapy
Time Frame
at definitive surgery (20-24 weeks after the first dose of study medication)
Title
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)
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Xinjiang Medical School Cancer Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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