Fasting on Newly Diagnosed Breast Cancer — STEFNE  

HER2-positive Breast Cancer Clinical Trial

Official title: A Pilot Study of Short-term Fasting on Neoadjuvant Chemotherapy in Patients With Newly Diagnosed Breast Cancer (STEFNE Study)

Status Terminated

Clinical Trial Summary

This study is to see how safe the use of short-term fasting is in breast cancer patients who will receive chemotherapy before undergoing surgery and to examine if the use of short-term fasting will decrease the side effects of chemotherapy and how much a tumor shrinks while receiving chemotherapy.

Clinical Trial Description

Patients will fast 24 hours before and 24 hours after the administration of chemotherapy which will consist of doxorubicin plus cyclophosphamide every 2 weeks for four cycles followed by paclitaxel every 2 weeks for four cycles (dose-dense AC + T) or docetaxel (T) every 3 weeks for four cycles. Trastuzumab (H) and Pertuzumab (P) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pathological complete remission (pCR), adjuvant chemotherapy with doxorubicin (A) plus cyclophosphamide (C) every 3 weeks for four cycles will be given, followed by trastuzumab every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC). ;

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

• NCT number: NCT02379585
• Study type: Interventional
• Source: Western Regional Medical Center
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: January 2013
• Completion date: August 2015