NCT01957332Active, not recruiting
IMaging PAtients for Cancer Drug selecTion - Metastatic Breast Cancer
Towards Patient Tailored Cancer Treatment Supported by Molecular Imaging IMPACT: IMaging PAtients for Cancer Drug selecTion - Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 20 Nov 2024
Brief summary (registry, in English)
Current patient work-up, including conventional imaging and pathological assessment of just one single biopsy, might be insufficient to identify metastatic breast cancer patients, who possibly benefit from first-line anti-hormonal or anti-HER2 therapy. As receptor conversion of the tumor is found quite frequently and molecular heterogeneity can occur within one patient, up-to-date whole body information is necessary to determine estrogen receptor (ER) and/or human epidermal growth factor receptor 2 (HER2) receptor status and subsequently guide therapy decision. With molecular imaging via PET this information can be obtained in a non-invasive, patient friendly way. Furthermore, to improve and individualize treatment and be able to identify (new) drug targets and biomarkers, sampling of venous blood, circulating tumor cells (CTC), as well as circulating tumor DNA, microRNA (miRNA) and molecular characterization of one metastasis at the beginning and, if feasible, of an additional biopsy during therapy, is necessary.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 217 (actual)
- First submitted
- 3 Sept 2013
- Start date
- 30 Aug 2013
- Primary completion date
- Oct 2027
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Metastatic breast cancer
- NCT number
- NCT01957332
What you commit to
- Study type: Interventional
- Participants enrolled: 217
- From 30 Aug 2013 to the primary completion date, Oct 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications for systemic treatment (as will be assigned based on biopsy and experimental scan results), either chemotherapy, hormonal therapy or anti-HER2 therapy, based on clinical judgment of treating medical oncologist and patient history.
- Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
Other illness
- Rapidly progressive (visceral) disease requiring rapid initiation of chemotherapy.
Other
- Pregnant or lactating women.
- Inability to comply with study procedures.
Who the study is looking for
- Patient with first presentation of MBC, regardless of ER and HER2 status of the primary tumor, who is eligible for first-line systemic therapy.
- Patient with non-rapidly progressive MBC, not requiring urgent initiation of chemotherapy, based on clinician's evaluation which may include:
- no recent (\< 2 weeks prior to screening visit) significant worsening of MBC related signs and symptoms according to patient history.
- in case of liver metastases: no significant increase in liver function tests alanine aminotransferase aspartate transaminase (ASAT) and alanine transaminase (ALAT) in 2 weeks prior to screening visit. (Significant increase of liver function test is defined as 50% increase of absolute amount of ASAT/ALAT.)
- Patients in whom standard imaging work-up of MBC was recently (≤ 28 days) performed. Standard imaging must include: CT chest/abdomen, 18F-FDG-PET and bone scintigraphy.
- Patient with measurable or clinically evaluable (bone only) disease on recent standard work up of MBC are eligible.
- Metastatic lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
- Primary tumor blocks available for confirmatory central laboratory ER/HER2 testing in the UMCG. If available a snap frozen sample of the primary tumor will also be centralized in the University Medical Center Groningen (UMCG).
- WHO performance status 0-2.
- Patient is able to undergo PET imaging procedures.
- Age \>18 years of age, willing and able to comply with the protocol as judged by the investigator.
- Signed written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VU University Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| University Medical Center Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| University Medical Center St. Radboud Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.