Trial Outcomes & Findings for Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease (NCT NCT01387295)

Last Updated: 2023-12-11

Results Overview

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,

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

up to 24 months from baseline

Results posted on

2023-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Chemotherapy oxaliplatin, capecitabine, trastuzumab: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Overall Study STARTED	38
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy n=38 Participants oxaliplatin, capecitabine, trastuzumab: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Age, Categorical <=18 years	0 Participants n=38 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=38 Participants
Age, Categorical >=65 years	8 Participants n=38 Participants
Age, Continuous	54.5 years n=38 Participants
Sex: Female, Male Female	38 Participants n=38 Participants
Sex: Female, Male Male	0 Participants n=38 Participants
Region of Enrollment Denmark	38 participants n=38 Participants

PRIMARY outcome

Timeframe: up to 24 months from baseline

Outcome measures

Outcome measures
Measure	Chemotherapy n=38 Participants oxaliplatin, capecitabine, trastuzumab: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Response Rate CR	2 Participants
Response Rate PR	13 Participants
Response Rate SD	21 Participants
Response Rate PD	1 Participants
Response Rate NE	1 Participants

SECONDARY outcome

Timeframe: upon completion of treatment, an average of 7 months

Total number of patients receiving RF treatment or surgical treatment

Outcome measures

Outcome measures
Measure	Chemotherapy n=38 Participants oxaliplatin, capecitabine, trastuzumab: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Number of Patients Suitable for Local Therapy (Radiofrequency)	2 Participants

SECONDARY outcome

Timeframe: up to 7 years

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

Outcome measures

Outcome measures
Measure	Chemotherapy n=38 Participants oxaliplatin, capecitabine, trastuzumab: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Survival	24.0 months Interval 17.2 to 30.8

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Chemotherapy n=38 Participants oxaliplatin, capecitabine, trastuzumab: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Adverse Events	38 Participants

SECONDARY outcome

Timeframe: up to 6 years

From start of therapy to progression or death of any cause.

Outcome measures

Outcome measures
Measure	Chemotherapy n=38 Participants oxaliplatin, capecitabine, trastuzumab: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
PFS	12.8 months Interval 6.9 to 18.6

Adverse Events

Chemotherapy

Serious events: 8 serious events

Other events: 38 other events

Deaths: 33 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy n=38 participants at risk oxaliplatin, capecitabine, trastuzumab: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Injury, poisoning and procedural complications Morphine toxication	2.6% 1/38 • Number of events 1 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Vascular disorders Pulmonary embolism	5.3% 2/38 • Number of events 2 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
General disorders Fever	2.6% 1/38 • Number of events 1 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Hepatobiliary disorders gallbladder stone	2.6% 1/38 • Number of events 1 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Metabolism and nutrition disorders Diabetes mellitus	2.6% 1/38 • Number of events 1 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Infections and infestations Infection	7.9% 3/38 • Number of events 3 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years

Other adverse events

Other adverse events
Measure	Chemotherapy n=38 participants at risk oxaliplatin, capecitabine, trastuzumab: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Investigations Alanine aminotransferase increased	39.5% 15/38 • Number of events 38 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Investigations Aspartate aminotransferase increased	50.0% 19/38 • Number of events 77 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Investigations Alkaline phosphatase increased	36.8% 14/38 • Number of events 34 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Investigations Hyperbilirubinaemia	7.9% 3/38 • Number of events 8 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Investigations Thrombocytopenia	44.7% 17/38 • Number of events 82 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Investigations Neutropenia	39.5% 15/38 • Number of events 25 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Blood and lymphatic system disorders Anaemia	23.7% 9/38 • Number of events 12 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Nervous system disorders Dysaesthesia	92.1% 35/38 • Number of events 304 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Nervous system disorders Peripheral motor neuropathy	28.9% 11/38 • Number of events 41 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Nervous system disorders Peripheral sensory neuropathy	76.3% 29/38 • Number of events 179 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
General disorders Allergic reaction	7.9% 3/38 • Number of events 6 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
General disorders Fatigue	78.9% 30/38 • Number of events 159 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
General disorders Fever	23.7% 9/38 • Number of events 12 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
General disorders Pain	60.5% 23/38 • Number of events 59 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Gastrointestinal disorders Diarrhoea	55.3% 21/38 • Number of events 55 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Gastrointestinal disorders Stomatitis	55.3% 21/38 • Number of events 62 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Gastrointestinal disorders Nausea	89.5% 34/38 • Number of events 119 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Gastrointestinal disorders Vomiting	52.6% 20/38 • Number of events 36 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Gastrointestinal disorders Dyspepsia	13.2% 5/38 • Number of events 12 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	86.8% 33/38 • Number of events 184 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Skin and subcutaneous tissue disorders Alopecia	15.8% 6/38 • Number of events 6 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Musculoskeletal and connective tissue disorders Myalgia	13.2% 5/38 • Number of events 12 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Musculoskeletal and connective tissue disorders Arthralgia	10.5% 4/38 • Number of events 8 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Metabolism and nutrition disorders Anorexia	63.2% 24/38 • Number of events 91 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Infections and infestations infection	5.3% 2/38 • Number of events 3 • Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years

Additional Information

Dr Dorte Nielsen

Herlev University Hospital

Phone: +45 38682344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place