Metastatic Breast CancerPhase 2NCT01928680
Phase II Study of Capecitabine and Cisplatin to Treat Metastatic Triple Negative Breast Cancer
A Phase 2 study testing Cisplatin/Capecitabine in people with Metastatic Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
It is a phase II trial to explore the efficacy and safety of cisplatin plus capecitabine in anthracycline and taxane-pretreated metastatic triple negative breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Cisplatin/Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written and signed informed consent prior to beginning specific protocol procedures.
- Pathologically confirmed Estrogen Receptor(ER), Progesterone Receptor(PR) and Human Epidermal growth factor Receptor HER-2) negative ("triple negative") breast cancer and documented metastatic or locally advanced disease.
- Measurable disease - with at least 1 lesion measurable by radiological method
- KPS>=70
- 18 to 70 years old women
- Previously treated with an anthracycline and a taxane
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- Hormone therapy for early-stage or metastatic breast cancer was permitted if hormonal receptor positive.
- Treatment with Herceptin for early-stage or metastatic breast cancer is permitted if HER2 positive
- Laboratory requirements:
- Hematology Absolute neutrophil count>=1,500 /μl; Platelets>=100,000 /μl; Hemoglobin>=10 g/dl
- Liver function Total bilirubin<=2 times ULN ASAT (SGOT) and ALAT (SGPT)<=2.5 times UNL without liver metastasis or <=5.0 times if liver metastasis Glucose<=200 mg/dL
- Renal function Serum creatinine<=140 mol/l
- Life expectancy of at least 12 weeks
- Patients must be accessible for treatment and follow-up.
- Patients should have recovered from the acute reversible effects of prior treatment. This generally means at least 3 weeks should have elapsed since prior chemotherapy, adjuvant or Neoadjuvant treatment. and at least 4 weeks since prior (radical) radiotherapy or major surgery
Who cannot join
- Women who are pregnant or breast feeding
- History of brain and/or leptomeningeal metastases
- Past or current history of malignant neoplasm other than breast carcinoma, except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
- Pre-existing neuropathy grade 1 according to the NCIC-CTC 3.0
- Psychiatric disorders or other conditions which would prevent pt. compliance
- Other serious illness or medical condition:
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- Congestive heart failure, or unstable angina pectoris, previous history of myocardial infarction within 6 month prior to study entry, uncontrolled hypertension as determined by the Investigator or high risk uncontrolled, arrhythmia.
- History of significant neurological or psychiatric disorders including psychotic disorders, dementia of seizures that would prohibit the understanding and giving of informed consent.
- Active uncontrolled infection.
- Unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of Corticosteroids.
- Inability to take and/or absorb oral medicine
- Prior treatment with capecitabine and/or cisplatin
- Concurrent treatment with other experimental drugs, or participation in another clinical trial with any investigational drug within 30 days prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Capecitabine and Cisplatin in Anthracycline and Taxanes-pretreated Metastatic Triple Negative Breast Cancer Patients
It is a phase II trial to explore the efficacy and safety of cisplatin plus capecitabine in anthracycline and taxane-pretreated metastatic triple negative breast cancer patients.
Read the detailed description
Cisplatin contained regimens have been demonstrated to be effective in metastatic triple negative breast cancer patients in some phase II clinical trials. Meanwhile, Capecitabine is also a highly effective choice for metastatic breast cancer with considerable duration of response. Combination of cisplatin and capecitabine have been proved effective in metastatic breast cancer in several phase II trials. This study is aimed to investigate the efficacy and safety of this combination in triple negative breast cancer patients.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Cisplatin/Capecitabine
- Keywords
- Triple Negative Breast Cancer, Cisplatin, Capecitabine
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin/CapecitabineDrug
Also called Xeloda
Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin/Capecitabine | Experimental | Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.
This is a single arm phase II clinical trial. Receives: Drug: Cisplatin/Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Measured: 6 months
Secondary outcomes (3)
Progression Free Survival
Measured: 2 years
Overall Survival
Measured: 3 years
Number and Severity of Adverse Events of Patients Enrolled in This Trial
Number and severity of adverse events sufferred by patients who received capecitabine and cisplatin regimen.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startNov 2012
- Primary completionOct 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Qiao, Chinese Academy of Medical Sciences
- Investigators
- Binghe XU, MD, PHD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928680
- Sponsor's protocol ID
- LQ0001
- Other IDs
- CAMS-LQ0001
- Status last verified
- Feb 2015
- First submitted
- 1 May 2013
- Last updated
- 23 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Capecitabine and Cisplatin in Anthracycline and Taxanes-pretreated Metastatic Triple Negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01928680
- Acronym / sponsor ID
- LQ0001
- Conditions
- Metastatic Breast Cancer
- Keywords
- Triple Negative Breast Cancer, Cisplatin, Capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a phase II trial to explore the efficacy and safety of cisplatin plus capecitabine in anthracycline and taxane-pretreated metastatic triple negative breast cancer patients.
Detailed description
Cisplatin contained regimens have been demonstrated to be effective in metastatic triple negative breast cancer patients in some phase II clinical trials. Meanwhile, Capecitabine is also a highly effective choice for metastatic breast cancer with considerable duration of response. Combination of cisplatin and capecitabine have been proved effective in metastatic breast cancer in several phase II trials. This study is aimed to investigate the efficacy and safety of this combination in triple negative breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin/Capecitabine | Experimental | Drug: Cisplatin/CapecitabineCapecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity. This is a single arm phase II clinical trial. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written and signed informed consent prior to beginning specific protocol procedures.
- Pathologically confirmed Estrogen Receptor(ER), Progesterone Receptor(PR) and Human Epidermal growth factor Receptor HER-2) negative ("triple negative") breast cancer and documented metastatic or locally advanced disease.
- Measurable disease - with at least 1 lesion measurable by radiological method
- KPS>=70
- 18 to 70 years old women
Key exclusion criteria (13 listed)
- Women who are pregnant or breast feeding
- History of brain and/or leptomeningeal metastases
- Past or current history of malignant neoplasm other than breast carcinoma, except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
- Pre-existing neuropathy grade 1 according to the NCIC-CTC 3.0
- Psychiatric disorders or other conditions which would prevent pt. compliance
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 |
|---|---|---|
| Cisplatin/CapecitabineAlso: XelodaCisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity | Drug | Cisplatin/Capecitabine |
Primary outcome
Overall Response Rate
Time frame: 6 months
3 secondary outcomes
Progression Free Survival
Time frame: 2 years
Overall Survival
Time frame: 3 years
Number and Severity of Adverse Events of Patients Enrolled in This Trial
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MD, PHD 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 study testing Cisplatin/Capecitabine in people with Metastatic 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 15 inclusion and 13 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 23 Feb 2015. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (time frame: 6 months). 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 23 Feb 2015.