Metastatic Breast CancerPhase 2NCT01387295
Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease
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
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to 1 Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 determined by PET-CT-scan.
- No progression on treatment with capecitabine.
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- 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 in Patients With Limited Extrahepatic Disease
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 with limited extrahepatic disease are included.
- Conditions
- Metastatic Breast Cancer, Liver Metastases
- Being tested
- oxaliplatin, capecitabine, trastuzumab
- Keywords
- breast cancer, liver metastases, intrahepatic chemotherapy
- Medical subject headings
- Breast Neoplasms
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 and 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.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions,
Measured: up to 24 months from baseline
Secondary outcomes (4)
Number of Patients Suitable for Local Therapy (Radiofrequency)
Total number of patients receiving RF treatment or surgical treatment
Measured: upon completion of treatment, an average of 7 months
Survival
All patients in intent-to-treat population , calculated from start of treatment to death of any course
Measured: up to 7 years
Adverse Events
Number of participants with at least 1 AE related to study treatment - The details on which AEs occured are listed in the Adverse Event section below
Measured: from start of treatment to 28 days after last treatment, an average of 7 months
PFS
From start of therapy to progression or death of any cause.
Measured: up to 6 years
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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 38 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
- NCT01387295
- Sponsor's protocol ID
- MA 0918
- Status last verified
- Mar 2023
- First submitted
- 31 May 2011
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lindgaard SC, Brinch CM, Jensen BK, Norgaard HH, Hermann KL, Theile S, Larsen FO, Jensen BV, Michelsen H, Nelausen KM, Holm VH, Ekblad L, Soerensen PG, Nielsen DL. Hepatic arterial therapy with oxaliplatin and systemic capecitabine for patients with liver metastases from breast cancer. Breast. 2019 Feb;43:113-119. doi: 10.1016/j.breast.2018.12.002. Epub 2018 Dec 5.
PubMed 30544058
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. 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 in Patients With Limited Extrahepatic Disease
- ClinicalTrials.gov ID
- NCT01387295
- Acronym / sponsor ID
- MA 0918
- Conditions
- Metastatic Breast Cancer, Liver Metastases
- Keywords
- breast cancer, liver metastases, intrahepatic chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 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
- Posted 11 Dec 2023
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 with limited 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 (13 listed)
- 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 determined by PET-CT-scan.
Key exclusion criteria (16 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 and trastuzumab systemic | Drug | chemotherapy |
Primary outcome
Response Rate
Time frame: up to 24 months from baseline
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. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions,
4 secondary outcomes
Number of Patients Suitable for Local Therapy (Radiofrequency)
Time frame: upon completion of treatment, an average of 7 months
Survival
Time frame: up to 7 years
Adverse Events
Time frame: from start of treatment to 28 days after last treatment, an average of 7 months
PFS
Time frame: up to 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30544058Lindgaard SC, Brinch CM, Jensen BK, Norgaard HH, Hermann KL, Theile S, Larsen FO, Jensen BV, Michelsen H, Nelausen KM, Holm VH, Ekblad L, Soerensen PG, Nielsen DL. Hepatic arterial therapy with oxaliplatin and systemic capecitabine for patients with liver metastases from breast cancer. Breast. 2019 Feb;43:113-119. doi: 10.1016/j.breast.2018.12.002. Epub 2018 Dec 5.
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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 13 inclusion and 16 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 11 Dec 2023. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2023). 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?
Response Rate (time frame: up to 24 months from baseline). 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 NCT01387295, 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 11 Dec 2023.