Pathological Complete Response Rate in Locally Advanced Breast Cancer With FEC, EC-T, or TC as Neoadjuvant Chemotherapy
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Nov 2017
Shorter than P25 for phase_2 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2017
CompletedFirst Posted
Study publicly available on registry
November 21, 2017
CompletedStudy Start
First participant enrolled
November 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2019
CompletedNovember 21, 2017
November 1, 2017
2 years
October 14, 2017
November 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Pathological Complete Response (pCR)
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.
2 years
Secondary Outcomes (1)
The relation between pCR rate, molecular subtypes, and different regiments.
2 years
Study Arms (3)
FEC group
EXPERIMENTALFluorouracil 500mg/m2 on day 1, epirubicin 100mg/m2 on day 1 and cyclophosphamide 500mg/m2 on day 1 every 3 weeks for six cycles
EC-T group
EXPERIMENTALEpirubicin 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
TC group
EXPERIMENTALDocetaxel 75mg/m2 on day 1 and cyclophosphamide 600mg/m2 on day 1 every 3 weeks for six cycles
Interventions
500mg/m2(FEC), 600mg/m2(EC-T and TC)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhiyong Yulead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhiyong Yu, PhD
Shandong Cancer Hospital and Institute
- PRINCIPAL INVESTIGATOR
Xiaoshan Cao, MD
Shandong Cancer Hospital and Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of the Breast Surgery Ⅰ
Study Record Dates
First Submitted
October 14, 2017
First Posted
November 21, 2017
Study Start
November 27, 2017
Primary Completion
November 27, 2019
Study Completion
November 27, 2019
Last Updated
November 21, 2017
Record last verified: 2017-11