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

April 19, 2022 updated by: Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital
      • Shenzhen, Guangdong, China
        • Peking University Shenzhen Hospital
    • Hunan
      • Changsha, Hunan, China
        • Second Xiangya Hospital of Central South University
    • Xinjiang
      • Urumqi, Xinjiang, China, 830000
        • Xinjiang Medical School Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Xeloda
Drug: Cyclophosphamide (tablet)
Cyclophosphamide 50 mg/d, po, d1-d21
Other Names:
  • CTX
Drug: Fluorouracil
Fluorouracil 500mg/m2, iv, d1
Other Names:
  • 5-Fu
Drug: Epirubicin
Epirubicin 100mg/m2, iv, d1
Drug: Cyclophosphamide (injection)
Cyclophosphamide 500mg/m2, iv, d1
Other Names:
  • 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 Names:
  • 5-Fu
Drug: Epirubicin
Epirubicin 100mg/m2, iv, d1
Drug: Cyclophosphamide (injection)
Cyclophosphamide 500mg/m2, iv, d1
Other Names:
  • CTX

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pathological complete response (pCR) rate
Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication)
at definitive surgery (20-24 weeks after the first dose of study medication)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Ultrasound response rate
Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication)
at definitive surgery (20-24 weeks after the first dose of study medication)
Breast-conserving surgery rate
Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication)
at definitive surgery (20-24 weeks after the first dose of study medication)
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)
during on-neoadjuvant therapy period (defined as the period from the first dose of study medication up to 30 days of the last dose)
Tumor Ki67 reduction rate in relation to neoadjuvant therapy
Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication)
at definitive surgery (20-24 weeks after the first dose of study medication)
Tumor CD31 reduction rate in relation to neoadjuvant therapy
Time Frame: at definitive surgery (20-24 weeks after the first dose of study medication)
at definitive surgery (20-24 weeks after the first dose of study medication)
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)
at definitive surgery (20-24 weeks after the first dose of study medication)
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)
at definitive surgery (20-24 weeks after the first dose of study medication)
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)
at definitive surgery (20-24 weeks after the first dose of study medication)
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)
at definitive surgery (20-24 weeks after the first dose of study medication)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCCT2016001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings