Phase 2
N=38
Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease
Metastatic Breast Cancer · Liver Metastases
Bottom Line
View on ClinicalTrials.gov: NCT01387295 ↗Enrolled (actual)
38
Serious AEs
21.1%
Results posted
Dec 2023
Primary outcome: Primary: Response Rate — 2; 13; 21; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- oxaliplatin, capecitabine, trastuzumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dorte Nielsen
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate |
2; 13; 21; 1; 1 | — |
| SECONDARY Number of Patients Suitable for Local Therapy (Radiofrequency) |
2 | — |
| SECONDARY Survival |
24.0 | — |
| SECONDARY Adverse Events |
38 | — |
| SECONDARY PFS |
12.8 | — |
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.
Only patients with limited extrahepatic disease are included.
Eligibility Criteria
Inclusion Criteria:• 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 determined by PET-CT-scan.
- No progression on treatment with capecitabine.
- Prior treatment with taxane (adjuvant or for metastatic disease)
- Metastases 1.5 x 109/l og thrombocytes > 100 x 109/l
- Bilirubin 30 ml/min.
- INR < 1.6.
- If the patient is HER2-positive: Baseline LVEF ≥ 50 %
Exclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT01387295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.