Breast Cancer Clinical Trial
Official title:
Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer
Verified date | May 2022 |
Source | Istituto Clinico Humanitas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators designed a phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach.
Status | Active, not recruiting |
Enrollment | 65 |
Est. completion date | October 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients aged >18 years with ECOG 0-2 - Diagnosis of Breast Cancer - DFI (Disease-free interval) > 1 year - No extrapulmonary and/or extrahepatic disease or other metastatic sites stable or responding after chemotherapy - No life threatening conditions - Lung and liver lesions < 5 (with maximum diameter < 5 cm) - Chemotherapy completed at least 3 weeks before treatment - Chemotherapy started at least 2 weeks after treatment allowed - Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or immunotherapy) - Written informed consent Exclusion Criteria: - ECOG > 2 - Pregnant women - Patients with inability to consent |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Clinico Humanitas | Rozzano | Milano |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4 | 3 years | ||
Primary | Local control of disease after SBRT according to EORTC questionnaire | 2 years | ||
Secondary | Progression free survival using Kaplan-Meyer statistical curves | 2 months | ||
Secondary | Overall survival using Kaplan-Meyer statistical curves | 2 months | ||
Secondary | Quality of life at the end of the treatment with questionnaire EORTC QLQ C30 | 2 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
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
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
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 |