Efficacy and Safety of Neoadjuvant DC-T in Breast Cancer Patients

Breast Cancer Clinical Trial

— ESNDBCP  

Official title:

The Efficacy and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Followed by Docetaxel in Breast Cancer Patients: A Multicentric, Open-label, Non-randomized Concurrent Control, Non-inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03123770
• Other study ID #: ESNDBCP
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2016
• Est. completion date: December 2021

Study information

• Verified date: April 2019
• Source: Zhejiang University
• Contact: Huang Jian, Dr
• Phone: 8657187315009
• Email: drhuangjiang[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicentric, open-label,non-randomized concurrent control, 1:1 match,non-inferiority trial that assesses the efficacy and safety of neoadjuvant chemotherapy regimen DC-T and EC-T in breast cancer patients.

Description:

OBJECTIVES: Determine the efficacy and safety of neoadjuvant chemotherapy regimen DC-T and EC-T in suitable breast cancer patients.

Participants are randomized to 1 of 2 treatment arms.

1. Arm I: Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery.

2. Arm II: Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery.

Patients in arms I and II will undergo physical examination, MRI, estimating of side effects every 4 cycles referring to RECIST (Response Evaluation Criteria In Solid Tumor) guideline. To adjust for potential bias, patients in DC-T arm were matched 1:1 to patients in the EC-T arm based on Her-2 and ER status. After finishing 8 cycles of neoadjuvant chemotherapy, every patient will receive mastectomy or breast-conserving surgery and then assess the pCR rate of primary lesion and axillary lymph nodes. Adjuvant radiotherapy and endocrine therapy will be taken if necessary. Every patient will be followed-up for five years to monitor survival condition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Women aged : 18~70 years.

2. WHO (ECOG) performance status 0-2.

3. Patients who have read and understand the informed consent form and have given written informed consent.

4. Diagnosed as invasive breast cancer by core biopsy

5. Diagnosed pre-surgically as (cTNM Staging)Stage II-III and suit for neoadjuvant chemotherapy.

6. Patients had previously not received chemotherapy,radiotherapy or biotherapy.

7. Normal organ function,meeting the requirement of laboratory testing below:

• WBC=4.0×109/L,

• NEU=1.5×109/L,

• PLT=100×109/L,

• HB =10g/dL,

• Scr=1.5× ULN,

• AST =2.5×ULN,

• ALT =2.5×ULN,

• TDIL=1.5×ULN.

8. Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline,(long diameter of primary lesion =1cm or minor diameter of lymph node =1.5cm);

Exclusion Criteria:

1. Pregnant or lactating women were excluded.

2. History of receiving organ transplantation(including Autologous bone marrow transplantation and peripheral hematopoietic stem-cell transplantation).

3. Dysfunction of peripheral nerve system caused by other diseases or history of either severe mental disorder or central nervous system disorders.

4. Uncontrolled infection or severe peptic ulcer need treatment.

5. Severe hepatic disease(such as hepatic cirrhosis),nephrosis,respiratory disease or uncontrolled diabetes.

6. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin.

7. Significant abnormal EKG or cardiac disease with drastic symptoms like congestive heart failure or severe coronary disease or uncontrolled arrhythmia or myocardial infarction within 12 months or NYHA level III-IV or LVEF<55% .

8. Be allergic to test drugs.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Pegylated liposomal doxorubicin
a new kind of doxorubicin
• Cyclophosphamide
traditional chemotherapy drug
• Epirubicin
traditional chemotherapy drug used in breast cancer
• Docetaxel
traditional chemotherapy drug used in breast cancer

Locations

Country	Name	City	State
China	Cancer institute	Hangzhou	Zhejiang

Sponsors (13)

Lead Sponsor

Collaborator

Zhejiang University

First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Zhejiang University, First People's Hospital of Hangzhou, Hangzhou Hospital of Traditional Chinese Medicine, Jinhua Central Hospital, Ningbo No. 1 Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sir Run Run Shaw Hospital, Women's Hospital School Of Medicine Zhejiang University, Zhejiang Cancer Hospital, Zhejiang Provincial Hospital of TCM, Zhejiang Provincial People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Gil-Gil MJ, Bellet M, Morales S, Ojeda B, Manso L, Mesia C, Garcia-Martínez E, Martinez-Jáñez N, Melé M, Llombart A, Pernas S, Villagrasa P, Blasco C, Baselga J. Pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel as primary chemotherapy in elderly or cardiotoxicity-prone patients with high-risk breast cancer: results of the phase II CAPRICE study. Breast Cancer Res Treat. 2015 Jun;151(3):597-606. doi: 10.1007/s10549-015-3415-2. Epub 2015 May 16. — View Citation

O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, Orlandi F, Mellars L, Alland L, Tendler C; CAELYX Breast Cancer Study Group. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 2004 Mar;15(3):440-9. — View Citation

Uriarte-Pinto M, Escolano-Pueyo Á, Gimeno-Ballester V, Pascual-Martínez O, Abad-Sazatornil MR, Agustín-Ferrández MJ. Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer. Int J Clin Pharm. 2016 Apr;38(2):446-53. doi: 10.1007/s11096-016-0278-5. Epub 2016 Mar 7. — View Citation

Vici P, Pizzuti L, Gamucci T, Sergi D, Conti F, Zampa G, Del Medico P, De Vita R, Pozzi M, Botti C, Di Filippo S, Tomao F, Sperduti I, Di Lauro L. Non-pegylated liposomal Doxorubicin-cyclophosphamide in sequential regimens with taxanes as neoadjuvant chemotherapy in breast cancer patients. J Cancer. 2014 Apr 25;5(6):398-405. doi: 10.7150/jca.9132. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response rate	The pathological complete response rate of primary lesion and axillary lymph nodes	5 years
Secondary	Side effects	Determine side effects of these drugs like cardiotoxicity ,hematological toxicity,gastrointestinal symptoms and so on.	5 years
Secondary	Overall survival	Determine the overall survival at 5 years.	5 years