PET/CT-biopsi study A PET/CT biopsy study in patients Capecitabine +/- Sorafenib in the treatment of locally advanced or metastatic HER2-negative breast cancer.

PET/CT-biopsi study A PET/CT biopsy sub study in patients who have given informed consent to participate in a randomized, dubbel blind, placebo controlled phase III trial with Capecitabine +/- Sorafenib in the treatment of locally advanced or metastatic HER2-negative breast cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002053-29-SE

Enrollment

Registered

2012-07-24

Start date

2012-08-10

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morphological verifications of metastatic lesions, PET Ribonucleic Acid (RNA)-expression study in subjects with locally advance or metastatic HER2-negative breast cancer. MedDRA version: 14.1 Level: LLT Classification code 10004244 Term: Benign breast neoplasm NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Nexavar Product Name: Nexavar Pharmaceutical Form: Film-coated tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Xeloda Produc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Signed Informed Consent for participation in the trial 12444 with EudraCT number 2012-018501-10. Signed Informed Consent for this trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Not defined.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to explore gene-expression profiling as a possible means of identifying gene signatures that could be predictive of therapeutic response, with focus on the combination of capecitabine and sorafenib versus capecitabine alone. The subjects who will participate are subjects with locally advanced or metastatic HER2-negative breast cancer and are participating in trial 12444 with EudraCT number 2012-018501-10. This sub study was initially submitted and approved as an amendment 5 to above trial 12444, and with EudraCT number 2012-018501-10. ;Secondary Objective: To correlate gene expression of tyrosine kinase receptors known to be affected by sorafenib with the phosphorylation status of these receptors; To compare the effects of the given therapies (ie, combination of sorafenib and capecitabine vs. capecitabine alone) as analyzed by [18F]-FDG-PET/CT, which will be performed at Day 1 and at Day 14, to conventional radiological evaluations. This trial will also allow comparison between the primary cancers (ie, the subject’s original biopsy), which will be analyzed as described in this trial, including single nucleotide polymorphisms (SNPs) and the metastatic lesions studied under this protocol. ;Primary end point(s): Not defined;Timepoint(s) of evaluation of this end point: Day 1 and day 14	—

Measure

Time frame

Main Objective: The primary objective of this study is to explore gene-expression profiling as a possible means of identifying gene signatures that could be predictive of therapeutic response, with focus on the combination of capecitabine and sorafenib versus capecitabine alone. The subjects who will participate are subjects with locally advanced or metastatic HER2-negative breast cancer and are participating in trial 12444 with EudraCT number 2012-018501-10. This sub study was initially submitted and approved as an amendment 5 to above trial 12444, and with EudraCT number 2012-018501-10. ;Secondary Objective: To correlate gene expression of tyrosine kinase receptors known to be affected by sorafenib with the phosphorylation status of these receptors; To compare the effects of the given therapies (ie, combination of sorafenib and capecitabine vs. capecitabine alone) as analyzed by [18F]-FDG-PET/CT, which will be performed at Day 1 and at Day 14, to conventional radiological evaluations. This trial will also allow comparison between the primary cancers (ie, the subject’s original biopsy), which will be analyzed as described in this trial, including single nucleotide polymorphisms (SNPs) and the metastatic lesions studied under this protocol. ;Primary end point(s): Not defined;Timepoint(s) of evaluation of this end point: Day 1 and day 14

—

Secondary

Measure	Time frame
Secondary end point(s): Not defined;Timepoint(s) of evaluation of this end point: NA	—

Countries

Sweden

Contacts

Public ContactOnkologiska kliniken

Karolinska Institutet and University

jonas.bergh@ki.se468517 76 279

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026