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

Primary Purpose

Breast Cancer, Pathological Complete Response, Neoadjuvant Chemotherapy

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Epirubicin

Fluorouracil

Docetaxel

Cyclophosphamide

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

FEC group

EC-T group

TC group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The relation between pCR rate, molecular subtypes, and different regiments.

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.

Full Information

NCT ID

NCT03349177

First Posted

October 14, 2017

Last Updated

November 18, 2017

Sponsor

Zhiyong Yu

1. Study Identification

Unique Protocol Identification Number

NCT03349177

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 27, 2017 (Anticipated)

Primary Completion Date

November 27, 2019 (Anticipated)

Study Completion Date

November 27, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zhiyong Yu

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Pathological Complete Response, Neoadjuvant Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FEC group

Arm Type

Experimental

Arm Description

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

Arm Title

EC-T group

Arm Type

Experimental

Arm Description

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

Arm Title

TC group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Epirubicin

Other Intervention Name(s)

Adriacin

Intervention Description

100mg/m2

Intervention Type

Drug

Intervention Name(s)

Fluorouracil

Other Intervention Name(s)

Fluorouracil injection

Intervention Description

500mg/m2

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Docetaxel injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Cyclophosphamide injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Participants With Pathological Complete Response (pCR)

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

The relation between pCR rate, molecular subtypes, and different regiments.

Description

Time Frame

2 years

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhiyong Yu, PhD

Phone

86-13355312277

drzhiyongyu@aliyun.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoshan Cao, MD

Phone

86-15154181183

caoxiaoshan2009@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhiyong Yu, PhD

Organizational Affiliation

Shandong Cancer Hospital and Institute

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Xiaoshan Cao, MD

Organizational Affiliation

Shandong Cancer Hospital and Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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