Breast CancerPhase 2NCT03204734
Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
A Phase 2 study testing Capecitabine and endocrine therapy in people with Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
A single-site study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive \& HER2-negative after capecitabine-base chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Capecitabine and endocrine therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 30 Dec 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- The age is Above 18 years of age, <70 years old
- HR-positive \& HER2-negative
- Metastatic breast cancer,incurable.
- For recurrent or metastatic lesions has had at least 1 but no more than 3 kinds of chemotherapy, if there is disease progression within 6 months after the end of the adjuvant chemotherapy, adjuvant chemotherapy will been the first-line treatment for metastatic lesions
- No prior use of capecitabine therapy or the use of capecitabine treatment was effective, and the efficacy evaluation was CR/PR/SD more than 6 months.
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- Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1
- The basic function of normal bone marrow
- Functions of liver and kidney is normal
- Expectation of life is more than 3 months
- Agreed to take contraceptive measures during treatment
Who cannot join
- Previous toxicity was not recovered to 0-1 degrees
- Central nervous system metastasis
- Pregnancy or lactation
- There are uncontrolled infection, myocardial infarction, thrombosis, etc.
- There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;
- Researchers believe that is not suitable for the study
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- Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;
- Bilateral breast cancer
- Capecitabine was ineffective in past treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiaojia WANG, MD,PhD, +86 13906500190, wxiaojia0803@163.com
Ya-bing Zheng, MD, +8613858065353, zhengyabing@sina.com
About this study
Official title: Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After 2nd-line or Over 2nd-line Therapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
A single-site study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive \& HER2-negative after capecitabine-base chemotherapy.
Read the detailed description
Capecitabine-base chemotherapy must be ≥Second-line Therapy
- Conditions
- Breast Cancer
- Being tested
- Capecitabine, endocrine therapy
- Keywords
- therapy, Capecitabine, 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.
CapecitabineDrug
Capecitabine will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.
endocrine therapyDrug
endocrine therapy will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.Endocrine therapy is determined by the doctor, including any kind of letrozole, anastrozole, exemestane, fulvestrant, tamoxifen, toremifene, combined with or without drugs or surgery in the inhibition of ovarian function.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Experimental | Capecitabine by mouth twice per day for 14 days, per 21 days as a cycle, until disease progress or toxicity can not be tolerated.Capecitabine starting dose was the dose used at the end of the combined chemotherapy regimen,eg:1000mg per BSA. Receives: Drug: Capecitabine |
| endocrine therapy | Experimental | endocrine therapy will been given as a sequential treatment in Metastatic breast cancer patients who are got benefit in capecitabine-base chemotherapy.The medicine will be confirmed by the patient's past-treatment. Receives: Drug: endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
Measured: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Secondary outcomes (5)
clinical benefit rate(CBR)
the response is CR+PR+SD ≥ 24 weeks
Measured: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
overall survival
the time elapsed between enrolling and death from any cause
Measured: From date of enrolling until the date of death from any cause, assessed up to 3 years
Number of participants with Grade 3/4 adverse events
Number of Participants with Grade 3/4 Adverse Events
Measured: From date of enrolling until the date of 1 month of stop treatment, assessed up to 3 years
Quality of life(QOL)（1）
change from enrolling to progression disease or death according EORTC QLQ-C30
Measured: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Quality of life(QOL)（2）
change from enrolling to progression disease or death according EORTC BR23
Measured: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jan 2016
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengyabing, Zhejiang Cancer Hospital
- Investigators
- Xiao-jia Wang, PHD,MD, Principal investigator, Zhejiang Cance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204734
- Sponsor's protocol ID
- ZJCH15009
- Status last verified
- Jun 2017
- First submitted
- 24 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muss HB, Case LD, Richards F 2nd, White DR, Cooper MR, Cruz JM, Powell BL, Spurr CL, Capizzi RL. Interrupted versus continuous chemotherapy in patients with metastatic breast cancer. The Piedmont Oncology Association. N Engl J Med. 1991 Nov 7;325(19):1342-8. doi: 10.1056/NEJM199111073251904.
PubMed 1922236
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After 2nd-line or Over 2nd-line Therapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03204734
- Acronym / sponsor ID
- ZJCH15009
- Conditions
- Breast Cancer
- Keywords
- therapy, Capecitabine, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 2 Jul 2017 (actual)
- 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.
A single-site study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive \& HER2-negative after capecitabine-base chemotherapy.
Detailed description
Capecitabine-base chemotherapy must be ≥Second-line Therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Experimental | Drug: CapecitabineCapecitabine by mouth twice per day for 14 days, per 21 days as a cycle, until disease progress or toxicity can not be tolerated.Capecitabine starting dose was the dose used at the end of the combined chemotherapy regimen,eg:1000mg per BSA. |
| endocrine therapy | Experimental | Drug: endocrine therapyendocrine therapy will been given as a sequential treatment in Metastatic breast cancer patients who are got benefit in capecitabine-base chemotherapy.The medicine will be confirmed by the patient's past-treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent
- The age is Above 18 years of age, <70 years old
- HR-positive \& HER2-negative
- Metastatic breast cancer,incurable.
- For recurrent or metastatic lesions has had at least 1 but no more than 3 kinds of chemotherapy, if there is disease progression within 6 months after the end of the adjuvant chemotherapy, adjuvant chemotherapy will been the first-line treatment for metastatic lesions
Key exclusion criteria (9 listed)
- Previous toxicity was not recovered to 0-1 degrees
- Central nervous system metastasis
- Pregnancy or lactation
- There are uncontrolled infection, myocardial infarction, thrombosis, etc.
- There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;
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 |
|---|---|---|
| CapecitabineCapecitabine will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy. | Drug | Capecitabine |
| endocrine therapyendocrine therapy will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.Endocrine therapy is determined by the doctor, including any kind of letrozole, anastrozole, exemestane, fulvestrant, tamoxifen, toremifene, combined with or without drugs or surgery in the inhibition of ovarian function. | Drug | endocrine therapy |
Primary outcome
Progression-free survival(PFS)
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
5 secondary outcomes
clinical benefit rate(CBR)
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
overall survival
Time frame: From date of enrolling until the date of death from any cause, assessed up to 3 years
Number of participants with Grade 3/4 adverse events
Time frame: From date of enrolling until the date of 1 month of stop treatment, assessed up to 3 years
Quality of life(QOL)（1）
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Quality of life(QOL)（2）
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 1922236Muss HB, Case LD, Richards F 2nd, White DR, Cooper MR, Cruz JM, Powell BL, Spurr CL, Capizzi RL. Interrupted versus continuous chemotherapy in patients with metastatic breast cancer. The Piedmont Oncology Association. N Engl J Med. 1991 Nov 7;325(19):1342-8. doi: 10.1056/NEJM199111073251904.
- 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.
Xiao-jia Wang, PHD,MD principal investigator
Zhejiang Cance Hospital
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 Capecitabine and endocrine therapy in people with Breast Cancer, run by Zhejiang Cancer Hospital 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 11 inclusion and 9 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 2 Jul 2017. 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 Xiao-jia Wang, PHD,MD (86 13906500190, wxiaojia0803@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 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 NCT03204734, which also lists 1 linked publication.
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 2 Jul 2017.