Breast Cancer Clinical Trial
Official title:
Early Identification of Patients Who Benefit From Palbociclib in Addition to Letrozole
Verified date | October 2022 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose is to evaluate whether non invasive in vivo imaging of the estrogen receptor (ER) presence in metastatic breast cancer patient by means of 18F-fluoro-estradiol (FES) positron emission tomography (PET) can be used to predict treatment response to palbociclib plus letrozole. As ER expression predicts response to palbociclib in metastatic breast cancer patients the investigators hypothesize that lesions with low uptake on FES-PET will not respond to the combination of letrozole plus palbociclib.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 28, 2022 |
Est. primary completion date | September 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Patients with ER positive (i.e. >1% staining), HER2 negative metastatic breast cancer (preferably assessment on fresh metastasis biopsy, alternatively archival metastasis biopsy) 2. Post-menopausal status defined as: - Age =60 years - Previous bilateral oophorectomy - Age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists - Age <60 years using ER antagonists should have amenorrhea for >12 months and FSH >24U/L and LH>14U/L 3. Adequate bone marrow and organ function defined as follows: - Absolute neutrophil count > 1.5 x 109/L - Platelet count >100 x 109/L - White blood cell count >3 x 109/L - AST and ALT <3.0 x upper limit of normal (ULN) or <5 xULN in case of known liver metastases. - Alkaline phosphatase <2.5 x ULN - Total serum bilirubin < ULN or total bilirubin <3.0 x ULN with direct bilirubin within normal range in patients with Gilbert's Syndrome - Creatinine clearance >50mL/min - Lipase/amylase <1/5 x ULN - Prothrombin time, partial thromboplastin time and INR <1.5 x ULN 4. ECOG performance 0-2 5. Signed written informed consent 6. Able to comply with the protocol 7. Age =18 years Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Life expectancy < 3 months 2. Evidence of central nervous system metastases 3. Presence of life-threatening visceral metastases 4. Prior use of CDK4/6 inhibitor 5. Use of estrogen receptor ligands including estrogens, fulvestrant or tamoxifen <6 weeks before study entry. 6. Use of other anticancer therapy < 2 weeks prior to start with palbociclib 7. Concurrent malignancy 8. Active cardiac disease or a history of cardiac dysfunction 9. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of treatment that are known strong inducers or inhibitors of CYP3A4/5, known risk to prolong the QT interval or induce Torsades de Pointes, or narrow therapeutic window and are predominantly metabolized through CYP3A4/5. |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The relation between low uptake on FES-PET to response per lesion | 8 weeks after start of treatment | ||
Secondary | quantitative FES-uptake and correlation with progression free survival | 6 months | ||
Secondary | analysis of circulating tumor DNA and correlation with FES-PET results and progression free survival | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |