Breast Cancer RecurrentPhase 2NCT02947061
S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer
A Phase 2 study testing S1 plus Docetaxel and Capecitabine plus Docetaxel in people with Breast Cancer Recurrent, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To compare the progression free survival(PFS) and safety of TS-S vs. TX-X in Patients With Advanced Breast Cancer first-line treatment Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Recurrent
- What is being tested?
- S1 plus Docetaxel and Capecitabine plus Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Apr 2019
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ≤ age ≤ 75;
- ECOG 0-2, The expected survival time more than 3 months;
- Histologically or cytologically proven locally advanced or advanced HER-2 negative breast cancer;
- No chemical treatment after Cancer recurrence;
- At least one measurable disease ( as per RECIST1.1);
- Adequate bone marrow functions (ANC ≥1.5×109 /L, PLT ≥100×109 /L, HB ≥90 g/L);
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- Adequate renal functions(serum creatinine ≤ 1.5 ULN; creatinine clearance≥50 ml/min);
- liver functions (serum bilirubin ≤ 1.5ULN, AST/ALT ≤ 2.5 ULN);
- Written informed consent;
- Pregnancy test (serum or urine) within 7 days of entry and willing to use the appropriate method of contraception.
Who cannot join
- Previously chemotherapy with cytotoxic drugs
- Pregnant, lactating women Did not take effective contraceptive measures
- Adjuvant chemotherapy/ neoadjuvant chemotherapy with 5-FU-based chemotherapy or Paclitaxel -based chemotherapy within 1 year after recurrence;
- Her-2 positive or unknown
- Other trails Before 4weeks
- Affection of the absorption of drugs(Unable to swallow、after gastrectomy、Chronic diarrhea and intestinal obstruction
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- Organs with rapid progression of invasion(Liver and lung lesions more than 1/2 organ area or hepatic insufficiency)
- Central nervous system disorders or mental disorders
- For docetaxel or fluorouracil or Twain 80 had serious adverse reactions or Allergy to 5-FU
- Severe upper gastrointestinal ulcer or absorption dysfunction syndrome
- Abnormal blood routine (ANC <1.5×109 /L, PLT <100×109 /L, HB <90 g/L);
- Renal functions(serum creatinine > 1.5 ULN);
- Liver functions (serum bilirubin > 1.5ULN
- Brain metastases out of control
- Other unapplicable
Trial locations and contacts
1 site in 1 country.
Binghe Xu, M.D. contact
Jiayu Wang, M.D. contact
China1 site, 1 recruiting
- Recruiting
No.17 panjiayuannanli, Chaoyang District
Beijing, Beijing Municipality, 100021
Binghe Xu, M.D., 86-10-88788826, xubinghe@medmail.com.cn
Jiayu Wang, M.D.
About this study
Official title: S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer: a Phase 2, Prospective,Multicenter, Randomised Study
To compare the progression free survival(PFS) and safety of TS-S vs. TX-X in Patients With Advanced Breast Cancer first-line treatment
Read the detailed description
To compare progression free survival (PFS) of the S-1 combined with docetaxel followed by maintenance treatment with S-1 and capecitabine combined with docetaxel followed by maintenance therapy with capecitabine in patients with advanced breast cancer first-line treatment.
- Conditions
- Breast Cancer Recurrent
- Being tested
- S1 plus Docetaxel, Capecitabine plus Docetaxel
- Keywords
- Advanced Breast Cancer,first treatment, S1, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1 plus DocetaxelDrug
S1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
Capecitabine plus DocetaxelDrug
Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | S1 plus Docetaxel ：S-1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1 Receives: Drug: S1 plus Docetaxel |
| control group | Active comparator | Capecitabine plus Docetaxel ：Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1 Receives: Drug: Capecitabine plus Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 2 years
Secondary outcomes (3)
overall survival
Measured: 1 year
objective response rate
Measured: 2 years
Disease control rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startApr 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer RecurrentStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binghe Xu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Binghe Xu, M.D., Principal investigator, Chinese Academy of Medical SciencesGuohui Han, M.D., Principal investigator, Tumor Hospital of Shanxi Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947061
- Sponsor's protocol ID
- CH-BC-033
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer: a Phase 2, Prospective,Multicenter, Randomised Study
- ClinicalTrials.gov ID
- NCT02947061
- Acronym / sponsor ID
- CH-BC-033
- Conditions
- Breast Cancer Recurrent
- Keywords
- Advanced Breast Cancer,first treatment, S1, Capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 27 Oct 2016 (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.
To compare the progression free survival(PFS) and safety of TS-S vs. TX-X in Patients With Advanced Breast Cancer first-line treatment
Detailed description
To compare progression free survival (PFS) of the S-1 combined with docetaxel followed by maintenance treatment with S-1 and capecitabine combined with docetaxel followed by maintenance therapy with capecitabine in patients with advanced breast cancer first-line treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Drug: S1 plus DocetaxelS1 plus Docetaxel ：S-1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1 |
| control group | Active comparator | Drug: Capecitabine plus DocetaxelCapecitabine plus Docetaxel ：Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 ≤ age ≤ 75;
- ECOG 0-2, The expected survival time more than 3 months;
- Histologically or cytologically proven locally advanced or advanced HER-2 negative breast cancer;
- No chemical treatment after Cancer recurrence;
- At least one measurable disease ( as per RECIST1.1);
Key exclusion criteria (15 listed)
- Previously chemotherapy with cytotoxic drugs
- Pregnant, lactating women Did not take effective contraceptive measures
- Adjuvant chemotherapy/ neoadjuvant chemotherapy with 5-FU-based chemotherapy or Paclitaxel -based chemotherapy within 1 year after recurrence;
- Her-2 positive or unknown
- Other trails Before 4weeks
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 |
|---|---|---|
| S1 plus DocetaxelS1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1 | Drug | test group |
| Capecitabine plus DocetaxelCapecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1 | Drug | control group |
Primary outcome
progression free survival
Time frame: 2 years
3 secondary outcomes
overall survival
Time frame: 1 year
objective response rate
Time frame: 2 years
Disease control rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Binghe Xu, M.D. contact
Jiayu Wang, M.D. contact
Binghe Xu, M.D. principal investigator
Chinese Academy of Medical Sciences
Guohui Han, M.D. principal investigator
Tumor Hospital of Shanxi Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S1 plus Docetaxel and Capecitabine plus Docetaxel in people with Breast Cancer Recurrent, 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 10 inclusion and 15 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 31 Oct 2016. 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 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?
Contact Binghe Xu, M.D. (010-87778826), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2016.