Neoadjuvant Trial of Capecitabine for Axillary Lymph Node Positive Operable Breast Cancer

Stage II Breast Cancer Clinical Trial

Official title:

Phase II Neoadjuvant Trial of Capecitabine, Cyclophosphamide and Epirubicin for Patients With Axillary Lymph Node Positive Stage II-III Operable Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02115152
• Other study ID #: JLiu
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 24, 2014
• Last updated: April 14, 2014
• Start date: June 2014

Study information

• Verified date: April 2014
• Source: Guangxi Medical University
• Contact: Jianlun Liu
• Email: jianlunliu[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomized phase II trial compared pathologic response rates (pCR) of early breast cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and capecitabine-epirubicin-cyclophosphamide (XEC).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Females aged 18-70 with histologically proven, core-biopsied, Stage II-III invasive breast cancer

• No distant disease

Exclusion Criteria:

• Inadequate heart or liver or kidney function

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Stage II Breast Cancer
• Stage III Breast Cancer

Intervention

Drug:
• fluorouracil

• capecitabine

• cyclophosphamide

• Epirubicin

Locations

Country	Name	City	State
China	Breast Cancer Surgery Department of Guangxi Medical University Cancer Center	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic response rates (pCR)	The absence of invasive tumor in the final surgical breast sample (stage yT0 or ypTis)	The breast sample will be evaluaed on the day of surgery during the cycle 4, an expected average of 12 weeks.	No
Secondary	DFS(Disease free survial)	Time from randmization to breast-cancer recurrence, or a second primay cancer(ecluding contralateral ducal carcinoma in situ), or death from any cause, whichever comes first	Participants will be evaluated on Day 1 of each cycle during chemotherapy, and Day 1 every 3 months after completion of chemotherapy. The expected average of 5 years.	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Adverse events are classified accoding NCI CTC criteria.	Hematologic, renal, and hepatic funcion will be assessed after each cycle and at the end of therapy, an expected average of 3 weeks.	Yes