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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Pegylated liposomal doxorubicin

Cyclophosphamide

Epirubicin

Docetaxel

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Neoadjuvant Chemotherapy, Pegylated liposomal doxorubicin, PLD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women aged : 18~70 years.
WHO (ECOG) performance status 0-2.
Patients who have read and understand the informed consent form and have given written informed consent.
Diagnosed as invasive breast cancer by core biopsy
Diagnosed pre-surgically as (cTNM Staging)Stage II-III and suit for neoadjuvant chemotherapy.
Patients had previously not received chemotherapy，radiotherapy or biotherapy.
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.
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:

Pregnant or lactating women were excluded.
History of receiving organ transplantation（including Autologous bone marrow transplantation and peripheral hematopoietic stem-cell transplantation).
Dysfunction of peripheral nerve system caused by other diseases or history of either severe mental disorder or central nervous system disorders.
Uncontrolled infection or severe peptic ulcer need treatment.
Severe hepatic disease（such as hepatic cirrhosis),nephrosis,respiratory disease or uncontrolled diabetes.
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.
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% .
Be allergic to test drugs.

Sites / Locations

Cancer instituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DC Follow T

EC Follow T

Arm Description

Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery.

Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery.

Outcomes

Primary Outcome Measures

Pathological complete response rate

The pathological complete response rate of primary lesion and axillary lymph nodes

Secondary Outcome Measures

Side effects

Determine side effects of these drugs like cardiotoxicity ,hematological toxicity，gastrointestinal symptoms and so on.

Overall survival

Determine the overall survival at 5 years.

Full Information

NCT ID

NCT03123770

First Posted

April 14, 2017

Last Updated

April 9, 2019

Sponsor

Zhejiang University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03123770

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast cancer, Neoadjuvant Chemotherapy, Pegylated liposomal doxorubicin, PLD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DC Follow T

Arm Type

Experimental

Arm Description

Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery.

Arm Title

EC Follow T

Arm Type

Active Comparator

Arm Description

Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery.

Intervention Type

Drug

Intervention Name(s)

Pegylated liposomal doxorubicin

Other Intervention Name(s)

PLD

Intervention Description

a new kind of doxorubicin

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Intervention Description

traditional chemotherapy drug

Intervention Type

Drug

Intervention Name(s)

Epirubicin

Other Intervention Name(s)

Intervention Description

traditional chemotherapy drug used in breast cancer

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Intervention Description

traditional chemotherapy drug used in breast cancer

Primary Outcome Measure Information:

Title

Pathological complete response rate

Description

The pathological complete response rate of primary lesion and axillary lymph nodes

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Side effects

Description

Determine side effects of these drugs like cardiotoxicity ,hematological toxicity，gastrointestinal symptoms and so on.

Time Frame

5 years

Title

Overall survival

Description

Determine the overall survival at 5 years.

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women aged : 18~70 years. WHO (ECOG) performance status 0-2. Patients who have read and understand the informed consent form and have given written informed consent. Diagnosed as invasive breast cancer by core biopsy Diagnosed pre-surgically as (cTNM Staging)Stage II-III and suit for neoadjuvant chemotherapy. Patients had previously not received chemotherapy，radiotherapy or biotherapy. 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. 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: Pregnant or lactating women were excluded. History of receiving organ transplantation（including Autologous bone marrow transplantation and peripheral hematopoietic stem-cell transplantation). Dysfunction of peripheral nerve system caused by other diseases or history of either severe mental disorder or central nervous system disorders. Uncontrolled infection or severe peptic ulcer need treatment. Severe hepatic disease（such as hepatic cirrhosis),nephrosis,respiratory disease or uncontrolled diabetes. 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. 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% . Be allergic to test drugs.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huang Jian, Dr

Phone

8657187315009

drhuangjiang@zju.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Zhang Zhigang, Dr

Phone

8657187315009

zzg2011@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huang Jian, Dr

Organizational Affiliation

Second Affiliated Hospital of Zhejiang University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Cancer institute

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhang Zhigang, Dr

Phone

8657187315009

zzg2011@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

14998846

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. doi: 10.1093/annonc/mdh097.

Results Reference

background

PubMed Identifier

24847380

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.

Results Reference

background

PubMed Identifier

25981896

Citation

Gil-Gil MJ, Bellet M, Morales S, Ojeda B, Manso L, Mesia C, Garcia-Martinez E, Martinez-Janez N, Mele 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.

Results Reference

background

PubMed Identifier

26951122

Citation

Uriarte-Pinto M, Escolano-Pueyo A, Gimeno-Ballester V, Pascual-Martinez O, Abad-Sazatornil MR, Agustin-Ferrandez 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.

Results Reference

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

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