Breast CancerPhase 2/3NCT01150513
Docetaxel+Carboplatin vs Epirubicin+Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
A Phase 2/3 study testing EC-T and TP in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no standard regimen. Some data showed that platins could improve the efficacy of advance TNBC. 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?
- EC-T and TP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Apr 2016
- Phase
- Phase 2/3
- 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
- Triple-negative breast cancer
- Older than 18 years old
- Have tumor resection surgery
- Sufficient organ function (marrow, heart, liver)
Who cannot join
- Other malignancy
- Other serious disease( marrow, heart, liver)
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute & Hospital Chinese Academy of Medical Sciences
Beijing, 100021
About this study
Official title: Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no standard regimen. Some data showed that platins could improve the efficacy of advance TNBC. In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).
- Conditions
- Breast Cancer
- Being tested
- EC-T, TP
- Keywords
- TRIPLE-NEGATIVE, BREAST CANCER
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC-TDrug
four cycles of EC (epirubicin: 90 mg/m2; cyclophosphamide :600 mg/m2, day 1) followed by four cycles of T (docetaxel : 75 mg/m2 or paclitaxel 175 mg/m2, day 1)
TPDrug
six cycles of TP (docetaxel: 75 mg/m2 or paclitaxel 175 mg/m2 d1; carboplatin AUC=5, day 1)
| Study group | Role | What they receive |
|---|---|---|
| EC-T | Active comparator | Not described Receives: Drug: EC-T |
| TP | Experimental | Not described Receives: Drug: TP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS) of 3 years
local recurrence, distant metastasis, the secondary primary malignancy
Measured: 3 years after mastectomy
Secondary outcomes (1)
Safety Profiles
All adverse events occurring during chemotherapy are to be recorded in the case report form, including hemotologic and nonhemotologic toxicities.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJun 2009
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Yuan, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Peng Yuan, MD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150513
- Sponsor's protocol ID
- CH-BC-007
- Status last verified
- Feb 2021
- First submitted
- 14 Jun 2010
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen Y, Wang X, Du F, Yue J, Si Y, Zhao X, Cui L, Zhang B, Bei T, Xu B, Yuan P. Association between homologous recombination deficiency and outcomes with platinum and platinum-free chemotherapy in patients with triple-negative breast cancer. Cancer Biol Med. 2023 Mar 2;20(2):155-68. doi: 10.20892/j.issn.2095-3941.2022.0525.
PubMed 36861447Zheng F, Du F, Wang W, Wang Y, Li M, Zhao J, Wang X, Yue J, Wang J, Yang Z, Cai R, Ma F, Fan Y, Li Q, Zhang P, Xu B, Yuan P. Updated efficacy of adjuvant epirubicin plus cyclophosphamide followed by taxanes versus carboplatin plus taxanes in early triple-negative breast cancer in phase 2 trial: 8.1-year median follow-up. Breast Cancer Res Treat. 2022 Jan;191(1):97-105. doi: 10.1007/s10549-021-06401-6. Epub 2021 Oct 14.
PubMed 34648118
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01150513
- Acronym / sponsor ID
- CH-BC-007
- Conditions
- Breast Cancer
- Keywords
- TRIPLE-NEGATIVE, BREAST CANCER
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no standard regimen. Some data showed that platins could improve the efficacy of advance TNBC. In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EC-T | Active comparator | Drug: EC-T |
| TP | Experimental | Drug: TP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Triple-negative breast cancer
- Older than 18 years old
- Have tumor resection surgery
- Sufficient organ function (marrow, heart, liver)
Key exclusion criteria (2 listed)
- Other malignancy
- Other serious disease( marrow, heart, liver)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EC-Tfour cycles of EC (epirubicin: 90 mg/m2; cyclophosphamide :600 mg/m2, day 1) followed by four cycles of T (docetaxel : 75 mg/m2 or paclitaxel 175 mg/m2, day 1) | Drug | EC-T |
| TPsix cycles of TP (docetaxel: 75 mg/m2 or paclitaxel 175 mg/m2 d1; carboplatin AUC=5, day 1) | Drug | TP |
Primary outcome
Disease Free Survival (DFS) of 3 years
Time frame: 3 years after mastectomy
local recurrence, distant metastasis, the secondary primary malignancy
1 secondary outcome
Safety Profiles
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Derived from this study: PubMed 36861447Chen Y, Wang X, Du F, Yue J, Si Y, Zhao X, Cui L, Zhang B, Bei T, Xu B, Yuan P. Association between homologous recombination deficiency and outcomes with platinum and platinum-free chemotherapy in patients with triple-negative breast cancer. Cancer Biol Med. 2023 Mar 2;20(2):155-68. doi: 10.20892/j.issn.2095-3941.2022.0525.
- Derived from this study: PubMed 34648118Zheng F, Du F, Wang W, Wang Y, Li M, Zhao J, Wang X, Yue J, Wang J, Yang Z, Cai R, Ma F, Fan Y, Li Q, Zhang P, Xu B, Yuan P. Updated efficacy of adjuvant epirubicin plus cyclophosphamide followed by taxanes versus carboplatin plus taxanes in early triple-negative breast cancer in phase 2 trial: 8.1-year median follow-up. Breast Cancer Res Treat. 2022 Jan;191(1):97-105. doi: 10.1007/s10549-021-06401-6. Epub 2021 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Yuan, MD principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EC-T and TP in people with Breast Cancer, run by Chinese Academy of Medical Sciences 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 9 Feb 2021. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) of 3 years (time frame: 3 years after mastectomy). 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 NCT01150513, which also lists 2 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 9 Feb 2021.