Metastatic Breast CancerPhase 2NCT01387373
Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer
A Phase 2 study testing oxaliplatin, capecitabine, trastuzumab in people with Metastatic Breast Cancer and Liver Metastases, run by Dorte Nielsen at 1 site in Denmark.
Trial summary
This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Liver Metastases
- What is being tested?
- oxaliplatin, capecitabine, trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to 1 Sep 2017
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Age > 18 years
- Performance status 0-1; expected survival ≥ 3 months
- Patient with histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the breast
- Liver metastases not suitable for local treatment
- Extrahepatic disease should be excluded by PET-CT-scan.
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- No progression on treatment with capecitabine.
- Prior treatment with taxane (adjuvant or for metastatic disease)
- Metastases < 70 % of the liver
- Neutrophile granulocytes > 1.5 x 109/l og thrombocytes > 100 x 109/l
- Bilirubin < 2.0 x UNL (upper normal limit).
- Creatinine-clearance > 30 ml/min.
- INR < 1.6.
- If the patient is HER2-positive:Baseline LVEF ≥ 50 %.
Who cannot join
- History of chemotherapy within the 4-week period prior to the start of trial medication
- Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
- Previous treatment with oxaliplatin
- Cytotoxic or experimental treatment within a 14 days period before start of trial medication
- The patient is not allowed to participate in other clinical trials.
- Any clinical symptoms suggesting peripheral neuropathy < or equal to grade 2 or CNS metastases (In case of clinical suspicion on CNS metastases a MR or CT scan should be performed within 4 weeks before inclusion
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- Other severe medical conditions e.g. severe cardial disease or AMI < 1 year
- Presence of diseases which prevent oral therapy. • Patients with uncontrolled infection
- Pregnant or lactating women
- Women capable of childbearing not using a sufficient non-hormonal method of birth control
- Patients not able to understand the treatment or to collaborate.
- Prior serious or unsuspected reaction after treatment with fluoropyrimidine
- Known prior hypersensitivity reactions to the agents.
- If the patient is HER2-positive:
- Dyspnoea in due to complication related to malignant disease e.g.lung metastases with lymphangitis or other conditions with need of supportive oxygen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Capecitabine in Patient With Non-resectable Liver Metastases From Breast Cancer. A Phase II Trial
This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer.
Only patients without extrahepatic disease are included.
- Conditions
- Metastatic Breast Cancer, Liver Metastases
- Being tested
- oxaliplatin, capecitabine, trastuzumab
- Keywords
- breast cancer, metastatic, liver metastases, intrahepatic, chemotherapy
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatin, capecitabine, trastuzumabDrug
Also called HAI
Oxaliplatin intrahepatic capecitabine + trastuzumab systemic
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Experimental | Not described Receives: Drug: oxaliplatin, capecitabine, trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Number of patients with complete or partial response in the liver (RECIST version 1.1)Only patients with measurable disease are included in the protocol. Response rate number of patients with CR + PR divided with total number
Measured: 6 months after inclusion of last patient
Secondary outcomes (4)
Time to progression a) Intrahepatic progression b) Extrahepatic progression
Time from treatment start to progression of disease or death of any cause.
Measured: 6 months after inclusion of last patient
Number of patients suitable for local therapy (radiofrequency)
Total number of patients receiving RF treatment or surgical treatment
Measured: 6 months after inclusion of last patient
Survival
All patients in intent-to-treat population , calculated from start of treatment to death of any cause
Measured: 6 months after inclusion of last patient
Toxicity
All patients who received at least one dose of study drug are evaluable for toxicity. CTC version 3.0 will be used.
Measured: 28 days after last patient last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startApr 2010
- Primary completion1 May 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dorte Nielsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dorte Nielsen, Herlev Hospital
- Investigators
- Dorte Nielsen, Professor, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387373
- Sponsor's protocol ID
- MA 0919
- Status last verified
- Oct 2020
- First submitted
- 31 May 2011
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Capecitabine in Patient With Non-resectable Liver Metastases From Breast Cancer. A Phase II Trial
- ClinicalTrials.gov ID
- NCT01387373
- Acronym / sponsor ID
- MA 0919
- Conditions
- Metastatic Breast Cancer, Liver Metastases
- Keywords
- breast cancer, metastatic, liver metastases, intrahepatic, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Dorte NielsenUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 4 Jul 2011 (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.
This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer.
Only patients without extrahepatic disease are included.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Experimental | Drug: oxaliplatin, capecitabine, trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Informed consent
- Age > 18 years
- Performance status 0-1; expected survival ≥ 3 months
- Patient with histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the breast
- Liver metastases not suitable for local treatment
Key exclusion criteria (15 listed)
- History of chemotherapy within the 4-week period prior to the start of trial medication
- Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
- Previous treatment with oxaliplatin
- Cytotoxic or experimental treatment within a 14 days period before start of trial medication
- The patient is not allowed to participate in other clinical trials.
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 |
|---|---|---|
| oxaliplatin, capecitabine, trastuzumabAlso: HAIOxaliplatin intrahepatic capecitabine + trastuzumab systemic | Drug | chemotherapy |
Primary outcome
Response rate
Time frame: 6 months after inclusion of last patient
Number of patients with complete or partial response in the liver (RECIST version 1.1)Only patients with measurable disease are included in the protocol. Response rate number of patients with CR + PR divided with total number
4 secondary outcomes
Time to progression a) Intrahepatic progression b) Extrahepatic progression
Time frame: 6 months after inclusion of last patient
Number of patients suitable for local therapy (radiofrequency)
Time frame: 6 months after inclusion of last patient
Survival
Time frame: 6 months after inclusion of last patient
Toxicity
Time frame: 28 days after last patient last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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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.
Dorte Nielsen, Professor principal investigator
professor
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 oxaliplatin, capecitabine, trastuzumab in people with Metastatic Breast Cancer and Liver Metastases, run by Dorte Nielsen at 1 site in Denmark.
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 14 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: finished, as of the sponsor's last update on 5 Oct 2020. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate (time frame: 6 months after inclusion of last patient). 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 5 Oct 2020.