Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients

May 23, 2016 updated by: Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Comparison of the Effectiveness of Neoadjuvant Chemotherapy and the Outcomes Associated With Chemo-induced Amenorrhea Between Docetaxel Plus Epirubicin, and Docetaxel Plus Epirubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients.

The current study is a multicentre, randomized, open (unblended), prospective clinical trial which is sponsored by the researchers. The trial is designed to compare the effectiveness between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant chemotherapies. The investigators will randomly assign 600 premenopausal female patients with operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy. Patients will undergo modified radical mastectomy or breast-conserving surgery after four cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two cycles), radiation therapy, herceptin targeted therapy or hormone therapy according to the NCCN (2011) guideline. The follow-up will be ten years after surgeries. The primary aim is to examine whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel, epirubicin, and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate, progression-free survival (PFS) and overall survival (OS)). The secondary aim is to correlate chemo (TE/TEC)-induced amenorrhea with outcomes in premenopausal women.

Study Overview

Status

Status

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

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.
600

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.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
          • Jie Yang
          • Phone Number: 86-13902805191
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
          • Siyu Wang
          • Phone Number: 86-18688464714
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Zhuanghong Wu
          • Phone Number: 86-13602722502
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-Sen University
        • Contact:
          • Renbin Liu
          • Phone Number: 86-13570073298
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Lehong Zhang
          • Phone Number: 86-13719150959
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The first affiliated hospital of Jinan University
        • Contact:
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangdong Women and Children Hospital
        • Contact:
          • Antai Zhang
          • Phone Number: 86-13925115929
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangzhou Army General Hospital
      • Guangzhou, Guangdong, China, 510095
        • Recruiting
        • Tumor Hospital of Guangzhou
        • Contact:
          • Hongsheng Li
          • Phone Number: 86-13725111258
      • Guangzhou, Guangdong, China, 510100
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
        • Contact:
          • Pengxi Liu
          • Phone Number: 86-13560333752
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital of Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Guangzhou Women and Children Hospital
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • The First People's Hospital of Guangzhou
        • Contact:
      • Guangzhou, Guangdong, China, 510282
        • Recruiting
        • Zhujiang Hospital of Nanfang Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Nanfang Medical University
        • Contact:
          • Changsheng Ye
          • Phone Number: 86-13802954097
      • Shenzhen, Guangdong, China, 518020
        • Recruiting
        • Shenzhen People's Hospital
        • Contact:
          • Dongxian Zhou
          • Phone Number: 86-13510363636
      • Shenzhen, Guangdong, China, 518035
        • Recruiting
        • The First Affiliated Hospital of Shenzhen University
        • Contact:
          • Xianming Wang
          • Phone Number: 86-13500056238

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. The patients signed the written informed consent.
  2. The patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.
  3. The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy.
  4. The patients have normal cardiac functions by echocardiography.
  5. The patients' ECOG scores are ≤ 0-2.
  6. The age of patient is ≥ 18 years old; And the patients are premenopausal females.
  7. The patients are disposed to practice contraception during the whole trial.

  8. The results of patients' blood tests are as follows:

    • Hb ≥ 90 g/L
    • WBC ≥ 4.0×109/L
    • Plt ≥ 100×109/L
    • Neutrophils ≥ 1.5×109/L
    • ALT and AST ≤ triple of normal upper limit.
    • TBIL ≤ 1.5 times of normal upper limit.
    • Creatinine ≤ 1.25 times of normal upper limit.

Exclusion Criteria:

  1. The patients have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.
  2. The patients have active infections that were not suitable for chemotherapy.
  3. The patients have severe non-cancerous diseases.
  4. The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.
  5. The patients whose breast cancers are HER2 positive and choose to undergo the neoadjuvant chemotherapy that includes herceptin regimen.
  6. The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.
  7. The patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.
  8. The patients have allergic history of the chemotherapeutic agents.
  9. The patients have bilateral breast cancers.

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.
Active Comparator: Docetaxel plus epirubicin
Drug: Docetaxel
75mg/m2, iv injection, day1, every 21 days
Drug: epirubicin
80mg/ m2, iv injection, day1, every 21 days
Procedure: Modified radical mastectomy or breast-conserving Surgery
Two weeks after four cycles of neoadjuvant chemotherapy
Drug: Docetaxel (post-operative)
Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Drug: Epirubicin (post-operative)
Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally
Radiation: Radiation therapy
Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline.
Drug: Herceptin （post-operative)
Perform herceptin therapy (one year) based on 2011 NCCN guideline if the pathological test of the operative tumor sample showed HER2 positive.
Drug: Tamoxifen (post-operative)
After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive.
Active Comparator: docetaxel plus epirubicin plus cyclophosphamide
Drug: Docetaxel
75mg/m2, iv injection, day1, every 21 days
Drug: epirubicin
80mg/ m2, iv injection, day1, every 21 days
Procedure: Modified radical mastectomy or breast-conserving Surgery
Two weeks after four cycles of neoadjuvant chemotherapy
Drug: Docetaxel (post-operative)
Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Drug: Epirubicin (post-operative)
Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally
Radiation: Radiation therapy
Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline.
Drug: Herceptin （post-operative)
Perform herceptin therapy (one year) based on 2011 NCCN guideline if the pathological test of the operative tumor sample showed HER2 positive.
Drug: Tamoxifen (post-operative)
After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive.
Drug: cyclophosphamide
500 mg/m2, iv injection, day1, every 21 days
Drug: Cyclophosphamide (post-operative)
Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally.

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
Progression-free survival of patients.
Time Frame: within 10 years after diagnosis
within 10 years after diagnosis
Overall survival of the patients
Time Frame: within 10 years after diagnosis
within 10 years after diagnosis

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
The pathological remission rate of patients after neoadjuvant chemotherapy.
Time Frame: within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
The clinical remission rate of patients after neoadjuvant chemotherapy
Time Frame: within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Fengxi Su, M.D., Sun Yat-Sen Memerial 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

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.
December 1, 2011

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.
May 1, 2018

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.
December 1, 2021

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).
December 29, 2011

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.
January 3, 2012

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.
January 4, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
May 24, 2016

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.
May 23, 2016

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.
May 1, 2016

More Information

Terms related to this study

Keywords

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.
  • BCSCO001

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.

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