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

NCT ID: NCT03349177

Last Updated: 2017-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2019-11-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Pathological Complete Response Neoadjuvant Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Epirubicin

Intervention Type DRUG

100mg/m2

Fluorouracil

Intervention Type DRUG

500mg/m2

Cyclophosphamide

Intervention Type DRUG

500mg/m2(FEC), 600mg/m2(EC-T and TC)

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

Group Type EXPERIMENTAL

Epirubicin

Intervention Type DRUG

100mg/m2

Docetaxel

Intervention Type DRUG

75mg/m2(TC), 100mg/m2(EC-T)

Cyclophosphamide

Intervention Type DRUG

500mg/m2(FEC), 600mg/m2(EC-T and TC)

TC group

Docetaxel 75mg/m2 on day 1 and cyclophosphamide 600mg/m2 on day 1 every 3 weeks for six cycles

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

75mg/m2(TC), 100mg/m2(EC-T)

Cyclophosphamide

Intervention Type DRUG

500mg/m2(FEC), 600mg/m2(EC-T and TC)

Interventions

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Epirubicin

100mg/m2

Intervention Type DRUG

Fluorouracil

500mg/m2

Intervention Type DRUG

Docetaxel

75mg/m2(TC), 100mg/m2(EC-T)

Intervention Type DRUG

Cyclophosphamide

500mg/m2(FEC), 600mg/m2(EC-T and TC)

Intervention Type DRUG

Other Intervention Names

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Adriacin Fluorouracil injection Docetaxel injection Cyclophosphamide injection

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhiyong Yu

OTHER

Sponsor Role lead

Responsible Party

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Zhiyong Yu

Director of the Breast Surgery Ⅰ

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhiyong Yu, PhD

Role: STUDY_CHAIR

Shandong Cancer Hospital and Institute

Xiaoshan Cao, MD

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Central Contacts

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Zhiyong Yu, PhD

Role: CONTACT

Phone: 86-13355312277

Email: [email protected]

Xiaoshan Cao, MD

Role: CONTACT

Phone: 86-15154181183

Email: [email protected]

Other Identifiers

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ShandongCHI-02

Identifier Type: -

Identifier Source: org_study_id