Advanced Breast CancerPhase 2NCT00717951
A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
A Phase 2 study testing docetaxol, cisplatin, capecitabine in people with Advanced Breast Cancer, run by Academy Military Medical Science, China.
Trial summary
Docetaxol plus capecitabine regimen is the standard treatment for the anthracycline-pretreated patients with advanced breast cancer. Cisplatin is an important drug for advanced breast cancer and potential effective drug for triple negative breast cancer.The study primary objective:Assess ORR,TTP,TTF and 2 year PFS… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- docetaxol, cisplatin, capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2008to May 2010
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age≥18y
- KPS≥ 70
- pathologic diagnosis of breast cancer
- at least 1 measurable lesion as defined by modified RECIST criteria
- screening laboratory values with the following parameters: hemoglobin:≥10.0 g/dl absolute neutrophils count:≥1.5×109/L platelet:≥100×109/L creatinine clearance rate: ≥60ml/min total bilirubin: ≤1.5 ×upper limits of normal Alkaline phosphatase,Aspartate aminotransferase and Alanine aminotransferase:≤ 2.5×upper limits of normal（≤5×upper limits of normal if liver metastasis are present)
- signed ICF
- for women of child bearing potential,a negative serum or urine pregnancy test result before study entry.
Who cannot join
- More than 2 cytotoxic chemotherapy treatment regimens for metastatic disease.
- prior exposure to 5-Fluorouracil continuous infusion.
- prior exposure docetaxol for metastatic disease
- Any other cancer within 5 years prior to screening with the exception of contralateral breast cancer,adequately treated cervical carcinoma in situ,or adequately treated basal or squamous cell carcinoma of skin
About this study
Docetaxol plus capecitabine regimen is the standard treatment for the anthracycline-pretreated patients with advanced breast cancer. Cisplatin is an important drug for advanced breast cancer and potential effective drug for triple negative breast cancer.The study primary objective:Assess ORR,TTP,TTF and 2 year PFS rate between docetaxol+capecitabine and docetaxol+cisplatin.
The second objective:Assess the safety and QOL.
Read the detailed description
The study main inclusion criteria are:1.age≥18,KPS>70.2.anthracycline-pretreated patients with advanced breast cancer.3.at least 1 measurable lesion as defined by modified RECIST criteria.4.screening laboratory values within the following parameters:ANC ≥1.5×109/L,Hemoglobin≥10.0 g/dl，Platelet≥100×109/L. 5. signed ICF The patients will be randomised two group: docetaxol+capecitabine and docetaxol+cisplatin. According to AE, the dose will be adjusted.
- Conditions
- Advanced Breast Cancer
- Being tested
- docetaxol, cisplatin, capecitabine
- Keywords
- advanced breast cancer, docetaxol, capecitabine, cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxol, cisplatin, capecitabineDrug
docetaxol(75mg/m2 d1 every 21 days) combined with cisplatin(75mg/m2 d1 every 21 days) VS docetaxol( 75mg/m2 d1 every 21 days) combined with capecitabine(2000mg/m2 d1-14 every 21 days)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Arm A is "docetaxol+capecitabine" chemotherapy Receives: Drug: docetaxol, cisplatin, capecitabine |
| B | Experimental | Arm B is "docetaxol+cisplatin" chemotherapy Receives: Drug: docetaxol, cisplatin, capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR,TTP,TTF and 2 year PFS
Measured: 2008-2010
Secondary outcomes (1)
safety and QOL
Measured: 2008-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2009 (estimated)
- Study completionMay 2010 (estimated)
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 Advanced 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academy Military Medical Science, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences
- Investigators
- jiang zefei, Ph.D, Principal investigator, Academy MMS,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717951
- Sponsor's protocol ID
- TAX625
- Other IDs
- CBCSG003
- Status last verified
- May 2008
- First submitted
- 14 Jul 2008
- Last updated
- 25 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
PubMed 34037241Egger SJ, Chan MMK, Luo Q, Wilcken N. Platinum-containing regimens for triple-negative metastatic breast cancer. Cochrane Database Syst Rev. 2020 Oct 21;10(10):CD013750. doi: 10.1002/14651858.CD013750.
PubMed 33084020
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00717951
- Acronym / sponsor ID
- TAX625
- Conditions
- Advanced Breast Cancer
- Keywords
- advanced breast cancer, docetaxol, capecitabine, cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Academy Military Medical Science, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- May 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 18 Jul 2008 (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.
Docetaxol plus capecitabine regimen is the standard treatment for the anthracycline-pretreated patients with advanced breast cancer. Cisplatin is an important drug for advanced breast cancer and potential effective drug for triple negative breast cancer.The study primary objective:Assess ORR,TTP,TTF and 2 year PFS rate between docetaxol+capecitabine and docetaxol+cisplatin.
The second objective:Assess the safety and QOL.
Detailed description
The study main inclusion criteria are:1.age≥18,KPS>70.2.anthracycline-pretreated patients with advanced breast cancer.3.at least 1 measurable lesion as defined by modified RECIST criteria.4.screening laboratory values within the following parameters:ANC ≥1.5×109/L,Hemoglobin≥10.0 g/dl，Platelet≥100×109/L. 5. signed ICF The patients will be randomised two group: docetaxol+capecitabine and docetaxol+cisplatin. According to AE, the dose will be adjusted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: docetaxol, cisplatin, capecitabineArm A is "docetaxol+capecitabine" chemotherapy |
| B | Experimental | Drug: docetaxol, cisplatin, capecitabineArm B is "docetaxol+cisplatin" chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age≥18y
- KPS≥ 70
- pathologic diagnosis of breast cancer
- at least 1 measurable lesion as defined by modified RECIST criteria
- screening laboratory values with the following parameters: hemoglobin:≥10.0 g/dl absolute neutrophils count:≥1.5×109/L platelet:≥100×109/L creatinine clearance rate: ≥60ml/min total bilirubin: ≤1.5 ×upper limits of normal Alkaline phosphatase,Aspartate aminotransferase and Alanine aminotransferase:≤ 2.5×upper limits of normal（≤5×upper limits of normal if liver metastasis are present)
Key exclusion criteria (4 listed)
- More than 2 cytotoxic chemotherapy treatment regimens for metastatic disease.
- prior exposure to 5-Fluorouracil continuous infusion.
- prior exposure docetaxol for metastatic disease
- Any other cancer within 5 years prior to screening with the exception of contralateral breast cancer,adequately treated cervical carcinoma in situ,or adequately treated basal or squamous cell carcinoma of skin
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 |
|---|---|---|
| docetaxol, cisplatin, capecitabinedocetaxol(75mg/m2 d1 every 21 days) combined with cisplatin(75mg/m2 d1 every 21 days) VS docetaxol( 75mg/m2 d1 every 21 days) combined with capecitabine(2000mg/m2 d1-14 every 21 days) | Drug | A, B |
Primary outcome
ORR,TTP,TTF and 2 year PFS
Time frame: 2008-2010
1 secondary outcome
safety and QOL
Time frame: 2008-2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2008.
- Derived from this study: PubMed 34037241Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
- Derived from this study: PubMed 33084020Egger SJ, Chan MMK, Luo Q, Wilcken N. Platinum-containing regimens for triple-negative metastatic breast cancer. Cochrane Database Syst Rev. 2020 Oct 21;10(10):CD013750. doi: 10.1002/14651858.CD013750.
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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.
jiang zefei, Ph.D principal investigator
Academy MMS,China
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxol, cisplatin, capecitabine in people with Advanced Breast Cancer, run by Academy Military Medical Science, 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 7 inclusion and 4 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 25 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
ORR,TTP,TTF and 2 year PFS (time frame: 2008-2010). 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 NCT00717951, 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 25 Jul 2008.