Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000206729
Ethics application status
Approved
Date submitted
16/02/2013
Date registered
21/02/2013
Date last updated
4/10/2022
Date data sharing statement initially provided
4/10/2022
Date results information initially provided
4/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized, Multi-Centre, Open-Label Study of Neo-adjuvant Taxanes and Capecitabine(TX) versus Taxanes and Anthracycline(TA) for Breast Cancer
Scientific title
A Randomized, Multi-Centre, Open-Label Study: Comparision of the efficacy and safety of Neo-adjuvant Taxanes and Capecitabine(TX) versus Taxanes and Anthracycline(TA) in Patients with Breast Cancer
Secondary ID [1] 280933 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 287026 0
Neoadjuvant chemotherpy 287027 0
Condition category
Condition code
Cancer 287354 287354 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients with breast cancer are randomly assigned to one of two groups, receiving taxanes and capecitabine(TX) or taxanes and anthracycline(TA) regimen in neoadjuvant setting. The treatment response would be evaluated after the completion of two cycles. In compelte response , partial response, and stable patients, the therapy will be continued to four cycles , but patients with progressive lesions will be excluded(individualized therapy will be considered). After four cycle chemotherapy, surgery will be carried out and pathological response will be assessed. The specific surgery type, breast conserving surgery or modified radical mastectomy, will be dependent on individual patient.
1. TX arm: paclitaxel 175mg/m2, or docetaxel 75 mg/m2, introvenous, once every 3 weeks, combined with Capecitabine 1000mg/m2, oral, twice every day for 14 days,every 3 weeks.
2. TA arm: paclitaxel 175mg/m2, or docetaxel 75 mg/m2, introvenous, once every 3 weeks, combined with epirubicin 75mg/m2, introvenous, once every 3 weeks.
Intervention code [1] 285369 0
Treatment: Drugs
Comparator / control treatment
TA regimen
Control group
Active

Outcomes
Primary outcome [1] 288850 0
pathological complete response (pCR) rate (pCR is defined as no residual cancer at histologic examination
)
Timepoint [1] 288850 0
after the surgery
Secondary outcome [1] 301147 0
the adverse effect of the chemotherapy:
1. Common toxic reaction is assessed according to National Cancer Institution (NCI) Toxicity Criteria
2. Hand-foot sydrome (HFS) is recorded according to the HFS grading scale (online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2796406/table/T1/)
Timepoint [1] 301147 0
One week after every cycle and 3 months after the completion of the chemotherapy

Eligibility
Key inclusion criteria
1.Histological comfirmed breast cancer
2.Non-special type breast cancer
2.With at least one measurable lesion
3.Without distant metastasis
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Without any contradiction of chemotherapy or the drug concerned
2.ECOG score > 1
3.No systemic anti-cancer therapy before

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone , and by computer in some centers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1. Randomized block design is used
2. The sequence was created by a computer software ( SAS)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/09/2012
Actual
24/08/2012
Date of last participant enrolment
Anticipated
Actual
29/12/2018
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
400
Accrual to date
Final
166
Recruitment outside Australia
Country [1] 4447 0
China
State/province [1] 4447 0
Beijing

Funding & Sponsors
Funding source category [1] 285718 0
Charities/Societies/Foundations
Name [1] 285718 0
Chinese Anti-Cancer Association Committee of Breast Cancer Society
Country [1] 285718 0
China
Primary sponsor type
Hospital
Name
Peking University People's Hospital Breast Center
Address
Peking University People's Hospital Breast Cancer Center,No 11 Xizhimen South Street,Beijing 100044
Country
China
Secondary sponsor category [1] 284547 0
Charities/Societies/Foundations
Name [1] 284547 0
Chinese Anti-Cancer association Committee of Breast Cancer Society
Address [1] 284547 0
5-A-10,Lanyuan Road, Huayuan Industrial Park, Tianjin 300000
Country [1] 284547 0
China
Other collaborator category [1] 276986 0
Hospital
Name [1] 276986 0
People's Liberation Army General Hospital
Address [1] 276986 0
No 28 Fuxing Lu, Haidian District,Beijing 100000
Country [1] 276986 0
China
Other collaborator category [2] 276987 0
Hospital
Name [2] 276987 0
Peking University First Hospital
Address [2] 276987 0
No 8 Xishiku Street, West City District, Beijing 100000
Country [2] 276987 0
China
Other collaborator category [3] 277283 0
Hospital
Name [3] 277283 0
Beijing Tongren Hospital
Address [3] 277283 0
No 2 Chongwenmennei Street, Dongcheng District, Beijing 100730
Country [3] 277283 0
China
Other collaborator category [4] 277284 0
Hospital
Name [4] 277284 0
Beijing Friendship Hospital
Address [4] 277284 0
No 95 Yong'an Lu, Xuanwu District, Beijing 100000
Country [4] 277284 0
China
Other collaborator category [5] 277287 0
Hospital
Name [5] 277287 0
307 Hospital of PLA
Address [5] 277287 0
No 8 East Avenue , Fengtai District, Bejing 100000
Country [5] 277287 0
China
Other collaborator category [6] 277288 0
Hospital
Name [6] 277288 0
Beijing Shijitan Hospital
Address [6] 277288 0
No.10, Tieyi Road, Yangfangdian, Haidian District, Beijing 100000
Country [6] 277288 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287728 0
Peking University People's Hospital Ethics Committee
Ethics committee address [1] 287728 0
Peking University People's Hospital,No 11 Xizhimen South Street,Beijing 100044
Ethics committee country [1] 287728 0
China
Date submitted for ethics approval [1] 287728 0
Approval date [1] 287728 0
27/06/2012
Ethics approval number [1] 287728 0

Summary
Brief summary
This is a randomized clinical trial comparing combination of taxanes and capecitabine (TX) versus the combination of taxanes and anthracycline (TA) in neoadjuvant setting in patients with stage II-III breast cancer. The first end point is treatment response (pCR rate). And the adverse effect related to the preoperative cytotoxic therapy is assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34503 0
Prof Shu Wang
Address 34503 0
Peking University People's Hospital Breast Center,No11 Xizhimen South Street, Beijing 10044
Country 34503 0
China
Phone 34503 0
+86,010,88324010
Fax 34503 0
Email 34503 0
[email protected]
Contact person for public queries
Name 17750 0
Dr Houpu Yang
Address 17750 0
Peking University People's Hospital Breast Center,No11 Xizhimen South Street, Beijing 10044
Country 17750 0
China
Phone 17750 0
+86,010,88324010
Fax 17750 0
+86,010,88324013
Email 17750 0
[email protected]
Contact person for scientific queries
Name 8678 0
Prof Shu Wang
Address 8678 0
Peking University People's Hospital Breast Center,No11 Xizhimen South Street, Beijing 10044
Country 8678 0
China
Phone 8678 0
+86,010,88324011
Fax 8678 0
+86,010,88324013
Email 8678 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Between September 1, 2012, and December 31, 2018, ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNeoadjuvant docetaxel and capecitabine (TX) versus docetaxel and epirubicin (TE) for locally advanced or early her2-negative breast cancer: an open-label, randomized, multi-center, phase II Trial.2022https://dx.doi.org/10.1186/s12885-022-10439-0
N.B. These documents automatically identified may not have been verified by the study sponsor.