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Status unknownNCT03123770ESNDBCPUpdated Apr 10, 2019

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

A Phase 4 interventional study of Pegylated liposomal doxorubicin and Cyclophosphamide in Breast Cancer, sponsored by Zhejiang University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by Zhejiang University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Dec 2016, registered Apr 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
384
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

  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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast cancer
  • Neoadjuvant Chemotherapy
  • Pegylated liposomal doxorubicin
  • PLD
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 384 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
384 participants (estimated)

Study arms

  • Experimental
    DC Follow T

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

    Drug: Pegylated liposomal doxorubicin · Drug: Cyclophosphamide · Drug: Docetaxel

  • Active comparator
    EC Follow T

    Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery.

    Drug: Cyclophosphamide · Drug: Epirubicin · Drug: Docetaxel

Interventions

  • DrugPegylated liposomal doxorubicin

    a new kind of doxorubicin

    Also known as: PLD

  • DrugCyclophosphamide

    traditional chemotherapy drug

    Also known as: C

  • DrugEpirubicin

    traditional chemotherapy drug used in breast cancer

    Also known as: E

  • DrugDocetaxel

    traditional chemotherapy drug used in breast cancer

    Also known as: T

06

What researchers measure

Primary outcomes

  1. Pathological complete response rate

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

    Time frame: 5 years

Secondary outcomes

  1. Side effects

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

    Time frame: 5 years

  2. Overall survival

    Determine the overall survival at 5 years.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Cancer institute
    Hangzhou, Zhejiang 310009, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 14998846 ↗
  • 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. PubMed 24847380 ↗
  • 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. PubMed 25981896 ↗
  • 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. PubMed 26951122 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03123770
Lead 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
Responsible party
Zhigang Zhang (Dr, Zhejiang University) — Principal investigator
First posted
Apr 21, 2017
Start date
Dec 2016
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Apr 10, 2019

Study contacts

Huang Jian, Dr
Contact
drhuangjiang@zju.edu.cn
8657187315009
Zhang Zhigang, Dr
Contact
zzg2011@zju.edu.cn
8657187315009
Huang Jian, Dr
study chair · Second Affiliated Hospital of Zhejiang University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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