Trial of Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy

Sponsor

RenJi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02879513

Collaborator

(none)

290

Enrollment

Location

Arms

107

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those who had pathological complete response to DP will be randomized to have 2 cycles of DP or have no further chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Invasive Ductal Breast Cancer Tubular Breast Cancer Mucinous Breast Cancer Inflammatory Breast Cancer	Drug: Paclitaxel Drug: Cisplatin Drug: Epirubicin Drug: Cyclophosphamide Drug: 5-fluoruracil	Phase 3

Detailed Description

All the patients who had neoadjuvant chemotherapy and had pathological complete response (pCR) or partial response to DP will enrolled in this trial. Those who had pCR will randmized to have two cycles of DP as adjuvant chemotherapy or have no further chemotherapy. Those patients who had PR will be randomized to have two cycles of DP or four cycles of CEF. All the patients with hormonal receptor positive or Her2 overexpress tumors are allowed to accept endocrine therapy or anti-Her2 target therapy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

290 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Phase III Trial of Comparing Combination Administration of Paclitaxel and Cisplatin Versus CEF as Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy

Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Switch to CEF Epirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks.	Drug: Epirubicin Drug: Cyclophosphamide Drug: 5-fluoruracil Other Names: 5-FU
Experimental: Continue the neoadjuvant regimen Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.	Drug: Paclitaxel Other Names: Taxol Drug: Cisplatin
Experimental: Pathological complete response group with chemotherapy Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.	Drug: Paclitaxel Other Names: Taxol Drug: Cisplatin
No Intervention: Pathological complete response group with no chemotherapy

Outcome Measures

Primary Outcome Measures

Disease-free survival (DFS) [Up to 5 years]

Secondary Outcome Measures

overall survival (OS) [Up to 5 years]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [4 months during adjuvant therapy]
regional recurrence free survival (RRFS) [5 years]
local recurrence free survival (LRFS) [5 years]
distant-disease- free survival (DDFS) [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women aged ≥18years and ≤70 years;
Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy.
Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Endocrine therapy and trastuzumab were allowed to use.
ECOG 0-2;
Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL;
No obvious main organs dysfunction.

Exclusion Criteria:

Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;
Patient is pregnant or breast feeding;
Metastatic breast cancer;
Any evidence of sense or motor nerve disorders;
Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;
Any concurrent malignancy other than breast cancer;
Know severe hypersensitivity to any drugs in this study.