Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease

NCT01387295 | Completed Phase 2 Results DMC

• 1 other identifier: MA 0918
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Breast Cancer; Liver Metastases

Keywords

breast cancer; liver metastases; intrahepatic chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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,

  up to 24 months from baseline

Secondary Outcomes (4)

• Number of Patients Suitable for Local Therapy (Radiofrequency)

  upon completion of treatment, an average of 7 months

• Survival

  up to 7 years

• Adverse Events

  from start of treatment to 28 days after last treatment, an average of 7 months

• PFS

  up to 6 years

Study Arms (1)

chemotherapy

EXPERIMENTAL

Drug: oxaliplatin, capecitabine, trastuzumab

Interventions

oxaliplatin, capecitabine, trastuzumab DRUG

Oxaliplatin intrahepatic capecitabine and trastuzumab systemic

Also known as: HAI

chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 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 %

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dorte Nielsen: lead

Study Sites (1)

Herlev Hospital

Herlev, DK-2730, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30544058 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Oxaliplatin; Capecitabine; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr Dorte Nielsen
• Organization: Herlev University Hospital

dorte.nielsen.01@regionh.dk

+45 38682344

Study Officials

• Dorte Nielsen, Professor

  professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital.

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: July 4, 2011
• Study Start: April 1, 2010
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 11, 2023
• Results First Posted: December 11, 2023

Record last verified: 2023-03

Locations

DK (1)