Breast CancerMACRONCT02012634
Metronomic Chemotherapy of Capecitabine After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer
An observational study of Breast Cancer and Capecitabine, run by Xijing Hospital at 1 site in China.
Trial summary
A Multi-center, III Phase,Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer, Capecitabine, Triple Negative Breast Cancer
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2018
- Phase
- Observational
- 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
Study population: Breast cancer patients of vascular endocrine surgery department in Xijing Hospital
Who may be able to join
- Female;
- aged 18 - 70 years old;
- Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable);
- Newly diagnosed conditions allowing direct surgery without any absolute contraindication for surgery;
- No mass or microscopic tumor residue after surgery resection;
- Initiate adjuvant chemotherapy within 30 days after surgery;
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- Axillary lymph node positive (including the sentinel lymph node positive and lymph node positive after axillary dissection), for example, axillary lymph node negative requires that primary tumor size must be greater than 1cm;
- Definite reports on ER/PR(progesterone receptor)/Her2 receptor showing all ER/PR/Her2 negative (specific definitions: immunohistochemical detection of ER <10% tumor cells is defined as ER negative, PR <10% positive tumor cells is defined as PR-negative, Her2 is 0~1+ or 2+ but determined negative via FISH or CISH detected (no amplification) is defined as Her2 negative);
- No relevant clinical or imaging evidence of metastasis showing in the preoperative examination (M0);
- Without peripheral neuropathy;
- ECOG performance score is 0 or 1;
- Postoperative recovery was good and an interval of at least one week since the surgery is necessary;
- White blood cell count> 4 × 10^9/l, neutrophil count> 2 × 10^9/l, platelet count> 100 × 10^9/l and hemoglobin 9g/dl);
- ASAT and ALAT <1.5 folds of the upper limit of normal values, alkaline phosphatase <2.5 folds of the upper limit of normal values, total bilirubin <1.5 folds of the upper limit of normal values;
- Serum creatinine <1.5 folds of the upper limit of normal value;
- Women at childbearing age should take contraception measures during treatment;
- Cardiac function: echocardiographic examination showed LEVF> 50%;
- Informed consent form signed.
Who cannot join
- Bilateral breast cancer or carcinoma in situ (DCIS / LCIS);
- Metastasis at any location;
- Any tumor > T4a (UICC1987) (accompanied by skin involvement, lump adhesion and fixation, inflammatory breast cancer);
- Any of ER, PR or Her-2 is positive;
- Contralateral breast clinically or radiologically suspected to be malignant but not confirmed which needs a biopsy;
- Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;
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- Previously suffering from malignant tumors (except for basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer;
- Already enrolled into other clinical trials;
- Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study LEVF <50% (echocardiography);
- Suffering from severe cardiovascular and cerebrovascular diseases within six months before the randomization (such as: unstable angina, chronic heart failure, uncontrollable high blood pressure > 150/90mmHg, myocardial infarction or brain vascular accident);
- Known allergic to taxane and anthracycline agents;
- Women at childbearing age refuse to take contraception measures during the treatment and 8 weeks after completion of treatment;
- Pregnant and breast-feeding women;
- Pregnancy test showed positive results before drug administration after enrolling in to the study; With mental illness and cognitive impairment, unable to understand trial protocol and side effects and complete trial protocol and follow-ups (systematic evaluation is required before recruiting into this study);
- Without personal freedom and independent civil capacity.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital ，Fourth Military Medical University
Xi'an, Shaanxi, 710032
Nanlin Li, Doctor, +86-137-0911-3279, nanlin-74@163.com
Chen Cong, Master, +86-136-4929-4730, congcongfeiyang@126.com
About this study
Official title: A Multi-center, III Phase，Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer
A Multi-center, III Phase,Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer
Read the detailed description
Capecitabine comes as a tablet to take by mouth. It is usually taken twice a day (in the morning and in the evening) for 2 weeks, followed by a 1 week break before repeating the next dosage cycle. In this study, capecitabine will be prescribed as dosage of 900mg/m2, and maintain for a whole year after the standard treatment in operable triple negative breast cancer patients. DFS is set as the primary outcome, OS and DDFS are also observed as the secondary outcomes. Statistical analysis are made to see whether this metronomic therapy of capecitabine ( 900mg/m2) will bring benefit to any of the iterms above.
- Conditions
- Breast Cancer, Capecitabine, Triple Negative Breast Cancer
- Keywords
- Breast Cancer, Capecitabine, Triple Negative Breast CancerTNBC（TNBC）
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS（Progression-free survival）
PFS was defined as the time from the date of randomization until the date of disease progression at any site including distant metastasis or second primary tumors or death， assessed up to 3 years
Measured: Progression-free survival：time from the date of randomization until the date of disease progression，assessed up to 3 years
Secondary outcomes (2)
OS
OS was defined as the time from the date of randomization until the date of any death occurred
Measured: time from the date of randomization until the date of any death occurred
DDFS
Measured: time from the date of randomization until the date of any disease occurred
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital
- Investigators
- Nanlin Li, Doctor, Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012634
- Sponsor's protocol ID
- TPYS-01
- Acronym
- MACRO
- Status last verified
- Nov 2014
- First submitted
- 26 Nov 2013
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, III Phase，Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02012634
- Acronym / sponsor ID
- MACRO / TPYS-01
- Conditions
- Breast Cancer, Capecitabine, Triple Negative Breast Cancer
- Keywords
- Breast Cancer, Capecitabine, Triple Negative Breast CancerTNBC（TNBC）
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Dec 2013 (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.
A Multi-center, III Phase,Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer
Detailed description
Capecitabine comes as a tablet to take by mouth. It is usually taken twice a day (in the morning and in the evening) for 2 weeks, followed by a 1 week break before repeating the next dosage cycle. In this study, capecitabine will be prescribed as dosage of 900mg/m2, and maintain for a whole year after the standard treatment in operable triple negative breast cancer patients. DFS is set as the primary outcome, OS and DDFS are also observed as the secondary outcomes. Statistical analysis are made to see whether this metronomic therapy of capecitabine ( 900mg/m2) will bring benefit to any of the iterms above.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients of vascular endocrine surgery department in Xijing Hospital
Key inclusion criteria (18 listed)
- Female;
- aged 18 - 70 years old;
- Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable);
- Newly diagnosed conditions allowing direct surgery without any absolute contraindication for surgery;
- No mass or microscopic tumor residue after surgery resection;
Key exclusion criteria (15 listed)
- Bilateral breast cancer or carcinoma in situ (DCIS / LCIS);
- Metastasis at any location;
- Any tumor > T4a (UICC1987) (accompanied by skin involvement, lump adhesion and fixation, inflammatory breast cancer);
- Any of ER, PR or Her-2 is positive;
- Contralateral breast clinically or radiologically suspected to be malignant but not confirmed which needs a biopsy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS（Progression-free survival）
Time frame: Progression-free survival：time from the date of randomization until the date of disease progression，assessed up to 3 years
PFS was defined as the time from the date of randomization until the date of disease progression at any site including distant metastasis or second primary tumors or death， assessed up to 3 years
2 secondary outcomes
OS
Time frame: time from the date of randomization until the date of any death occurred
DDFS
Time frame: time from the date of randomization until the date of any disease occurred
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
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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.
Nanlin Li, Doctor principal investigator
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Capecitabine, run by Xijing 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 18 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 13 Nov 2014. 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.
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 Chen Cong, Master (+86-13649294730, congcongfeiyang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS（Progression-free survival） (time frame: Progression-free survival：time from the date of randomization until the date of disease progression，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?
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 13 Nov 2014.