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Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer

Primary Purpose

Metastatic Breast Cancer, Liver Metastases

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

oxaliplatin, capecitabine, trastuzumab

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring breast cancer, metastatic, liver metastases, intrahepatic, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 excluded 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 %.

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.

Sites / Locations

Herlev Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to progression a) Intrahepatic progression b) Extrahepatic progression

Time from treatment start to progression of disease or death of any cause.

Number of patients suitable for local therapy (radiofrequency)

Total number of patients receiving RF treatment or surgical treatment

Survival

All patients in intent-to-treat population , calculated from start of treatment to death of any cause

Toxicity

All patients who received at least one dose of study drug are evaluable for toxicity. CTC version 3.0 will be used.

Full Information

NCT ID

NCT01387373

First Posted

May 31, 2011

Last Updated

October 1, 2020

Sponsor

Dorte Nielsen

1. Study Identification

Unique Protocol Identification Number

NCT01387373

Brief Title

Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

May 1, 2017 (Actual)

Study Completion Date

September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dorte Nielsen

4. Oversight

Data Monitoring Committee

5. Study Description

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 without extrahepatic disease are included.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Breast Cancer, Liver Metastases

Keywords

breast cancer, metastatic, liver metastases, intrahepatic, chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

chemotherapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

oxaliplatin, capecitabine, trastuzumab

Other Intervention Name(s)

HAI

Intervention Description

Oxaliplatin intrahepatic capecitabine + trastuzumab systemic

Primary Outcome Measure Information:

Title

Response rate

Description

Time Frame

6 months after inclusion of last patient

Secondary Outcome Measure Information:

Title

Time to progression a) Intrahepatic progression b) Extrahepatic progression

Description

Time from treatment start to progression of disease or death of any cause.

Time Frame

6 months after inclusion of last patient

Title

Number of patients suitable for local therapy (radiofrequency)

Description

Total number of patients receiving RF treatment or surgical treatment

Time Frame

6 months after inclusion of last patient

Title

Survival

Description

All patients in intent-to-treat population , calculated from start of treatment to death of any cause

Time Frame

6 months after inclusion of last patient

Title

Toxicity

Description

All patients who received at least one dose of study drug are evaluable for toxicity. CTC version 3.0 will be used.

Time Frame

28 days after last patient last dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 excluded 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 %. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dorte Nielsen, Professor

Organizational Affiliation

professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herlev Hospital

City

Herlev

ZIP/Postal Code

DK-2730

Country

Denmark

12. IPD Sharing Statement

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Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer

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