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

Inflammatory Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02879513
• Other study ID #: RenJiH-BC-003
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: December 2022

Study information

• Verified date: March 2019
• Source: RenJi Hospital
• Contact: Jinsong Lu, MD
• Email: lujjss[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: December 2022
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Women aged =18years and =70 years;

2. Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy.

3. Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST).

4. Endocrine therapy and trastuzumab were allowed to use.

5. ECOG 0-2;

6. 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;

7. No obvious main organs dysfunction.

Exclusion Criteria:

1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;

2. Patient is pregnant or breast feeding;

3. Metastatic breast cancer;

4. Any evidence of sense or motor nerve disorders;

5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;

6. Any concurrent malignancy other than breast cancer;

7. Know severe hypersensitivity to any drugs in this study.

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Ductal, Breast
• Inflammatory Breast Cancer
• Invasive Ductal Breast Cancer
• Mucinous Breast Cancer
• Tubular Breast Cancer

Intervention

Drug:
• Paclitaxel

• Cisplatin

• Epirubicin

• Cyclophosphamide

• 5-fluoruracil

Locations

Country	Name	City	State
China	Shanghai Jiaotong University School of Medicine, Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)		Up to 5 years
Secondary	overall survival (OS)		Up to 5 years
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		4 months during adjuvant therapy
Secondary	regional recurrence free survival (RRFS)		5 years
Secondary	local recurrence free survival (LRFS)		5 years
Secondary	distant-disease- free survival (DDFS)		5 years