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Breast CancerPhase 4ESNDBCPNCT03123770

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

A Phase 4 study testing Pegylated liposomal doxorubicin, Cyclophosphamide and Epirubicin in people with Breast Cancer, run by Zhejiang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Pegylated liposomal doxorubicin, Cyclophosphamide and Epirubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
384 participants
Where
1 siteChina
Study dates
Dec 2016to Dec 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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）；

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Huang Jian, Dr contact

8657187315009

drhuangjiang@zju.edu.cn

Zhang Zhigang, Dr contact

8657187315009

zzg2011@zju.edu.cn

China1 site, 1 recruiting

  • Cancer institute

    Hangzhou, Zhejiang, 310009

    Zhang Zhigang, Dr, 8657187315009, zzg2011@zju.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Conditions
Breast Cancer
Being tested
Pegylated liposomal doxorubicin, Cyclophosphamide, Epirubicin, Docetaxel
Keywords
Breast cancer, Neoadjuvant Chemotherapy, Pegylated liposomal doxorubicin, PLD
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pegylated liposomal doxorubicinDrug

    Also called PLD

    a new kind of doxorubicin

  • CyclophosphamideDrug

    Also called C

    traditional chemotherapy drug

  • EpirubicinDrug

    Also called E

    traditional chemotherapy drug used in breast cancer

  • DocetaxelDrug

    Also called T

    traditional chemotherapy drug used in breast cancer

Study groups in NCT03123770
Study groupRoleWhat they receive
DC Follow TExperimentalParticipants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery.
Receives: Drug: Pegylated liposomal doxorubicin; Drug: Cyclophosphamide; Drug: Docetaxel
EC Follow TActive comparatorParticipants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery.
Receives: Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response rate

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

    Measured: 5 years

Secondary outcomes (2)

  1. Side effects

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

    Measured: 5 years

  2. Overall survival

    Determine the overall survival at 5 years.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2017
  2. Study startDec 2016
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
384 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03123770
Sponsor's protocol ID
ESNDBCP
Acronym
ESNDBCP
Status last verified
Apr 2019
First submitted
14 Apr 2017
Last updated
10 Apr 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pegylated liposomal doxorubicin, Cyclophosphamide and Epirubicin in people with Breast Cancer, run by Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huang Jian, Dr (8657187315009, drhuangjiang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03123770, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.

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