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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03349177
• Other study ID #: ShandongCHI-02
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: October 14, 2017
• Last updated: November 18, 2017
• Start date: November 27, 2017
• Est. completion date: November 27, 2019

Study information

• Verified date: November 2017
• Source: Shandong Cancer Hospital and Institute
• Contact: Zhiyong Yu, PhD
• Phone: 86-13355312277
• Email: drzhiyongyu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoadjuvant Chemotherapy
• Pathological Complete Response

Intervention

Drug:
• Epirubicin
100mg/m2
• Fluorouracil
500mg/m2
• Docetaxel
75mg/m2(TC), 100mg/m2(EC-T)
• Cyclophosphamide
500mg/m2(FEC), 600mg/m2(EC-T and TC)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhiyong Yu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 years