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Trial record 28 of 99 for:    FEC

Pathological Complete Response Rate in Locally Advanced Breast Cancer With FEC, EC-T, or TC as Neoadjuvant Chemotherapy

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ClinicalTrials.gov Identifier: NCT03349177
Recruitment Status : Not yet recruiting
First Posted : November 21, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Zhiyong Yu, Shandong Cancer Hospital and Institute

Brief Summary:
Neoadjuvant chemotherapy (NAC) has become the standard therapy for both locally advanced and early-stage breast cancer in recent years for the improvement breast conserving surgery rate and the evaluation of treatment response in vivo. Pathological complete response (pCR) is an independent prognostic factor irrespective of breast cancer intrinsic subtypes after NAC. The trial is designed to compare effectiveness between anthracycline and/or taxane as neoadjuvant chemotherapy for operable advanced breast cancer in different molecular typing. In this trial the investigators will randomly assign 200 primary breast cancer patients to receive six cycles of fluorourcil, epirubicin,and cyclophosphamide(FEC), or four cycles of epirubicin and cyclophosphamide (EC) followed by four cycles of docetaxel(T), or six cycles of docetaxel and cyclophosphamide (TC). Trasuzumab was recommended combining docetaxel to patients if HER-2 positive.The effectiveness of therapy will be estimated after every two cycles of neoadjuvant chemotherapy. Surgery will be performed after completing designated full cycles of neoadjuvant chemotherapy. The primary endpoint is to assess pathologic complete response (pCR, ypT0/is ypN0) rate in different regiments. The secondary endpoint is to assess the relationship between pCR rate with molecular typing in different regiments, so that the investigators could optimize neoadjuvant chemotherapy regiment according to molecular typing.

Condition or disease Intervention/treatment Phase
Breast Cancer Pathological Complete Response Neoadjuvant Chemotherapy Drug: Epirubicin Drug: Fluorouracil Drug: Docetaxel Drug: Cyclophosphamide Phase 2 Phase 3

Detailed Description:
The trial is designed to compare effectiveness between anthracycline and/or taxane as neoadjuvant chemotherapy for operable advanced breast cancer in different molecular typing. In this trial the investigators will randomly assign 200 primary breast cancer patients to receive six cycles of fluorourcil, epirubicin,and cyclophosphamide(FEC), or four cycles of epirubicin and cyclophosphamide (EC) followed by four cycles of docetaxel(T), or six cycles of docetaxel and cyclophosphamide (TC). Trasuzumab was recommended combining docetaxel to patients if HER-2 positive.The effectiveness of therapy will be estimated after every two cycles of neoadjuvant chemotherapy. Surgery will be performed after completing designated full cycles of neoadjuvant chemotherapy. The primary endpoint is to assess pathologic complete response (pCR, ypT0/is ypN0) rate in different regiments. The secondary endpoint is to assess the relationship between pCR rate with molecular typing in different regiments, so that the investigators could optimize neoadjuvant chemotherapy regiment according to molecular typing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pathological Complete Response Rate in Locally Advanced Breast Cancer With Neoadjuvant Fluorourcil/Epirubicin/Cyclophosphamide, Epirubicin/Cyclophosphamide Followed by Docetaxel, or Docetaxel/Cyclophosphamide as Neoadjuvant Chemotherapy
Estimated Study Start Date : November 27, 2017
Estimated Primary Completion Date : November 27, 2019
Estimated Study Completion Date : November 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: FEC group
Fluorouracil 500mg/m2 on day 1, epirubicin 100mg/m2 on day 1 and cyclophosphamide 500mg/m2 on day 1 every 3 weeks for six cycles
Drug: Epirubicin
100mg/m2
Other Name: Adriacin

Drug: Fluorouracil
500mg/m2
Other Name: Fluorouracil injection

Drug: Cyclophosphamide
500mg/m2(FEC), 600mg/m2(EC-T and TC)
Other Name: Cyclophosphamide injection

Experimental: EC-T group
Epirubicin 100mg/m2 on day 1 cyclophosphamide 600mg/m2 on day1 every 2 weeks for four cycles followed by docetaxel 100mg/m2 on day 1 every 3 weeks for four cycles
Drug: Epirubicin
100mg/m2
Other Name: Adriacin

Drug: Docetaxel
75mg/m2(TC), 100mg/m2(EC-T)
Other Name: Docetaxel injection

Drug: Cyclophosphamide
500mg/m2(FEC), 600mg/m2(EC-T and TC)
Other Name: Cyclophosphamide injection

Experimental: TC group
Docetaxel 75mg/m2 on day 1 and cyclophosphamide 600mg/m2 on day 1 every 3 weeks for six cycles
Drug: Docetaxel
75mg/m2(TC), 100mg/m2(EC-T)
Other Name: Docetaxel injection

Drug: Cyclophosphamide
500mg/m2(FEC), 600mg/m2(EC-T and TC)
Other Name: Cyclophosphamide injection




Primary Outcome Measures :
  1. Percentage of Participants With Pathological Complete Response (pCR) [ Time Frame: 2 years ]
    Participants were evaluated following eight cycles of treatment and after surgery to assess for pCR. pCR was defined as no invasive or in situ residual tumor masses in the breast and lymph nodes according to pathologist examination. The percentage of participants with pCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.


Secondary Outcome Measures :
  1. The relation between pCR rate, molecular subtypes, and different regiments. [ Time Frame: 2 years ]
    The correlations were calculated using the Spearman rank correlation coefficient. The criteria for judging the size of the correlation coefficient were applied: correlations<0.30 are considered minor, correlations between 0.3-0.49 are considered medium, and ≥0.5 are considered strong. Cohen's kappa statistic was used to determine inter-examiner agreement. According to Altman's guidelines, it is poor when kappa scores ≤0.20, fair when kappa between 0.21-0.40, moderate when kappa between 0.41-0.60, good when kappa 0.61-0.80, and very good when kappa ≥0.80.



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

Inclusion Criteria:

  • All patients were required to give written informed consent.
  • Patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.
  • Have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy.
  • Have normal cardiac functions by echocardiography.
  • ECOG scores are ≤ 0-1.
  • Patients are disposed to practice contraception during the whole trial.
  • The results of patients' blood tests are as follows:

Hb ≥ 90 g/L WBC ≥ 3.0×109/L Plt ≥ 100×109/L Neutrophils ≥ 1.5×109/L ALT and AST ≤ 2.5 times of normal upper limit. TBIL ≤ 1.5 times of normal upper limit. Creatinine ≤ 1.5 times of normal upper limit.

Exclusion Criteria:

  • 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.
  • Active infections
  • Severe non-cancerous diseases.
  • The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.
  • Inflammatory breast cancer.
  • Pregnant or lactational, or patients refuse to practice contraception during the whole trial.
  • The patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.
  • Have allergic history of the chemotherapeutic agents.
  • Bilateral breast cancers.

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): NCT03349177


Contacts
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Contact: Zhiyong Yu, PhD 86-13355312277 drzhiyongyu@aliyun.com
Contact: Xiaoshan Cao, MD 86-15154181183 caoxiaoshan2009@163.com

Sponsors and Collaborators
Zhiyong Yu
Investigators
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Study Chair: Zhiyong Yu, PhD Shandong Cancer Hospital and Institute
Principal Investigator: Xiaoshan Cao, MD Shandong Cancer Hospital and Institute

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Responsible Party: Zhiyong Yu, Director of the Breast Surgery Ⅰ, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT03349177     History of Changes
Other Study ID Numbers: ShandongCHI-02
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Docetaxel
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
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors