Sequential Neo-adjuvant Chemotherapy Followed by Capecitabine Vs. Conventional Adjuvant Chemotherapy in Breast Cancer

NCT03011060 | Unknown Phase 3 DMC

• 1 other identifier: JLUDBSCRH 001
• Study Type: interventional
• Target: 1,588
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by Capecitabine could achieve additional benefits over traditional postoperative chemotherapy. In the study group, patients that do not achieve pathological complete response(pCR) will receive sequential neo-adjuvant chemotherapy followed by Capecitabine. In the control group, patients will be treated with postoperative adjuvant chemotherapy.

Conditions

Breast Neoplasm Female

Keywords

neo-adjuvant chemotherapy; pathological complete response; Neoadjuvant Therapy; Capecitabine; Chemotherapy, Adjuvant

Outcome Measures

Primary Outcomes (1)

• Disease-free survival(DFS)

  5 years

Secondary Outcomes (1)

• Overall survival(OS)

  5 years

Study Arms (3)

NAC not achieving pCR

EXPERIMENTAL

Patients in the study group will accept neo-adjuvant chemotherapy. Among these patients, those who do not achieve pCR after neo-adjuvant chemotherapy will be treated with Capecitabine after surgery. And then they will be followed up for 5 years. Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.

Procedure: Neo-adjuvant Chemotherapy; Drug: Capecitabine

NAC achieving pCR

EXPERIMENTAL

Patients in the study group will accept neo-adjuvant chemotherapy. In these patients, those who reach to pCR after neo-adjuvant chemotherapy will be followed up for 5 years after surgery.

Procedure: Neo-adjuvant Chemotherapy

Adjuvant Chemotherapy

NO INTERVENTION

Patients in the control group will accept surgeries and corresponding adjuvant chemotherapy.They will be followed up for 5 years after adjuvant chemotherapy.

Interventions

Neo-adjuvant Chemotherapy PROCEDURE

A preoperative chemotherapy based on anthracyclines and taxanes.

Also known as: Preoperative Chemotherapy, Primary Chemotherapy, Induction Chemotherapy

NAC achieving pCR; NAC not achieving pCR

Capecitabine DRUG

Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.

Also known as: Xeloda

NAC not achieving pCR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed unilateral invasive carcinoma (all pathological types);
• No gross or microscopic residual tumor after resection;
• Clinical stage Ⅰ-stage Ⅲ A, no absolute surgical contraindications;
• Eastern Cooperative Oncology Group(ECOG) score ≤1;
• Accepting adjuvant chemotherapy within 15 days after surgery;
• No peripheral neuropathy;
• Normal bone marrow and organ functions:
• Bone marrow function: ANC≥1500/mm3，PLT≥100000/mm3，HGB≥8g/dl
• Renal function: serum creatinine≤1.5 times the upper limit of normal(ULN), Liver function: total bilirubin ≤1.5 times the upper limit of normal，AST≤2.5 times the upper limit of normal，alanine aminotransferase(ALT)≤2.5 times the upper limit of normal
• Cardiac function:LVEF≥50%
• Signed informed consent form.

You may not qualify if:

• Patients with the history of oral fluorouracil chemotherapy or Chinese medicine treatment;
• Patients with organ dysfunction:
• Renal function: serum creatinine\>1.5 times the upper limit of normal
• Liver function: total bilirubin\>1.5 times the upper limit of normal，AST\>1.5 times the upper limit of normal, alanine aminotransferase(ALT)\>1.5 times the upper limit of normal or alkaline phosphatase (ALP) \>2.5 times the upper limit of normal
• Cardiac function：LVEF\<50%;
• Human epidermal growth factor receptor-2(HER-2) positive patients who cannot receive Herceptin treatment with a left ventricular ejection fraction(LVEF) less than 55%;
• Patients allergic to docetaxel, capecitabine, epirubicin and cyclophosphamide;
• Patients with severe systemic disease and/or uncontrollable infections;
• Patients with previous malignancies, including contralateral breast cancer;
• Patients with severe cardiovascular and cerebrovascular disease(i.e. Unstable angina, chronic cardiac failure, uncontrollable high blood pressure of \>150/90 mmhg, myocardial infarction and cerebrovascular accident) history within 6 months before randomization;
• Pregnant or lactating women.
• Patients who have cognitive or psychological impairment as well as cannot understand the test program or stand side effects, which will result in a suspension of the trial program and follow-up;
• Patients without personal freedom or independent civil capacity.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead
• First Hospital of China Medical University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• Qingdao University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Baotou Cancer Hospital: collaborator

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Related Publications (8)

• Fisher B, Brown A, Mamounas E, Wieand S, Robidoux A, Margolese RG, Cruz AB Jr, Fisher ER, Wickerham DL, Wolmark N, DeCillis A, Hoehn JL, Lees AW, Dimitrov NV. Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18. J Clin Oncol. 1997 Jul;15(7):2483-93. doi: 10.1200/JCO.1997.15.7.2483.

  PMID: 9215816 RESULT

• Bear HD, Anderson S, Smith RE, Geyer CE Jr, Mamounas EP, Fisher B, Brown AM, Robidoux A, Margolese R, Kahlenberg MS, Paik S, Soran A, Wickerham DL, Wolmark N. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer:National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006 May 1;24(13):2019-27. doi: 10.1200/JCO.2005.04.1665. Epub 2006 Apr 10.

  PMID: 16606972 RESULT

• Specht J, Gralow JR. Neoadjuvant chemotherapy for locally advanced breast cancer. Semin Radiat Oncol. 2009 Oct;19(4):222-8. doi: 10.1016/j.semradonc.2009.05.001.

  PMID: 19732686 RESULT

• Mathew J, Asgeirsson KS, Cheung KL, Chan S, Dahda A, Robertson JF. Neoadjuvant chemotherapy for locally advanced breast cancer: a review of the literature and future directions. Eur J Surg Oncol. 2009 Feb;35(2):113-22. doi: 10.1016/j.ejso.2008.03.015. Epub 2008 May 23.

  PMID: 18502088 RESULT

• Mieog JS, van de Velde CJ. Neoadjuvant chemotherapy for early breast cancer. Expert Opin Pharmacother. 2009 Jun;10(9):1423-34. doi: 10.1517/14656560903002105.

  PMID: 19505212 RESULT

• Alliot C. In vivo chemosensitivity-adapted preoperative chemotherapy in patients with early-stage breast cancer. Ann Oncol. 2005 Sep;16(9):1559-60; author reply 1560-1. doi: 10.1093/annonc/mdi287. Epub 2005 Aug 3. No abstract available.

  PMID: 16079161 RESULT

• Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Asola R, Kokko R, Ahlgren J, Auvinen P, Hemminki A, Paija O, Helle L, Nuortio L, Villman K, Nilsson G, Lahtela SL, Lehtio K, Pajunen M, Poikonen P, Nyandoto P, Kataja V, Bono P, Leinonen M, Lindman H; FinXX Study Investigators. Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for breast cancer: an open-label, randomised controlled trial. Lancet Oncol. 2009 Dec;10(12):1145-51. doi: 10.1016/S1470-2045(09)70307-9. Epub 2009 Nov 10.

  PMID: 19906561 RESULT

• M Toi, S-J Lee.Abstract S1-07: A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04). American Association for Cancer Research 76(4 Supplement):S1-07,2016

  RESULT

MeSH Terms

Interventions

Induction Chemotherapy; Capecitabine

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Fan Zhimin, Professor

  The First Hospital of Jilin University

  STUDY CHAIR

Central Study Contacts

Fan Zhimin, Professor

CONTACT

+8613756661286; fanzhimn@163.com

Han Bing, Professor

CONTACT

+8613504316519; han_bing@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 5, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: January 10, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)