Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Palbociclib

Protein Kinase Inhibitors

Enzyme Inhibitors

Observational study of Ibrance 75 mg, 100 mg and 125 mg.

Ibrance

Hormone therapy is the primary treatment option for patients with HR+ HER2- breast cancer. Despite its activity, hormone therapy is associated with initial, or more frequently acquired, resistance after exposure to one or more treatment lines.

The combination of palbociclib with hormone therapy significantly increases progression free survival (PFS) compared with hormone therapy in first and second treatment line of HR+ HER2- advanced breast cancer.

These results lead to palbociclib approval by the Food and Drug Administration (FDA) in February 2015, and European Medicines Agency (EMA) approval in November 2016 for first-line treatment of patients with metastatic HR+/HER2-breast cancer in combination with an aromatase inhibitor, and for patients who had previously received hormone therapy in combination with fulvestrant.

In Spain, palbociclib was launched last November 1st, 2017. During this period, approximately 3500 patients have received treatment with Palbociclib, and approximately a half of them in first-line treatment in combination with hormone therapy. The collection of efficacy and toxicity data in the first-line usage in the clinical practice setting is of clinical interest.

Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer

Observational Analysis of Treatment With Palbociclib in Patients With Locally Advanced and / or Metastatic RH + / HER 2- Breast Cancer in the First Line of Treatment Within Routine Clinical Practice.

Median time (months) from index date to death, disease progression based on radiology, laboratory evidence, pathology, or clinical assessment until next line therapy, or end of the study, whichever came first, assessed up to 52 months

Median time (months) from date of index treatment to date of death. Patients who did not die in the study period are censored at their last date in the study.

Real-world tumor response is defined as complete response or partial response, based on treating clinician's assessment of radiological evidence for change in burden of disease over the course of treatment

Median time (months) from date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months

Median time (months) from date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months

Hospital San Carlos, Madrid

Principal Investigator

Behavioral Intervention.

Nutritional Education.

G van Londen, MD, MS

Hormone responsive breast cancer is common and costly. Long-term adjuvant endocrine therapy (AET) improves breast cancer outcomes greatly, but, unfortunately, is commonly associated with physical and emotional concerns. I propose to evaluate the feasibility and preliminary effectiveness of a behavioral intervention to facilitate problem identification, provide education, coaching for breast cancer survivors with symptoms while on AET. Therefore, the intervention intends to empower women to engage in better self-care and seek out resources they need, which, in turn, will lead to better symptom management.

Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy

Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy.

University of Pittsburgh

Assistant Professor

The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months.

Pliates method treatment

INTRODUCTION: Breast cancer is one of the pathologies affecting women worldwide, with a high mortality rate of 14,206 per 100,000 women per year. However, Pilates was used as a therapeutic treatment for women who underwent a modified radical mastectomy, being associated with the alterations when in the postoperative sequels.

OBJECTIVE: to evaluate the Pilates Method in the functionality of women submitted to modified radical mastectomy.

METHOD: This is a quantitative clinical trial, in the form of women included in the project, to undergo a physical therapy rehabilitation program through the Pilates Method for 2 months, where they were evaluated before and after the procedure for measurement and comparison obtained.

CONCLUSION: In this way, the pilates method is presented as an instrument used for the rehabilitation of mastectomized women.

The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months

women in post-operative radical-mastectomy treatment.

PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY

PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY OF THE MASTECTOMIZED WOMEN

Medical Research Council scale for muscle power

Universidade Metodista de Piracicaba

Raphael do Nascimento Pereira

Rare Diseases

Oculocerebral Syndrome With Hypopigmentation

Trastuzumab

Emilio Alba

Main objective: To analyze the clinical and biological characteristics of patients with disseminated breast cancer HER2 + treated with trastuzumab that have achieved a complete remission, partial or stable disease for a period exceeding 3 years.

In addition, there will be a sub-genetic analysis of patients in whom there is availability a sample of primary tumor preserved in paraffin. This sub-analysis will not interfere with routine clinical practice, as the tumor samples based on which will be held on genetic profile, have been preserved in paraffin was extracted from the primary tumor to the patient.

SECONDARY OBJECTIVES:

* To determine the frequency of patients achieving partial response or stable disease for a period exceeding 3 years.
* Know the time to complete or partial remission or to achieve stabilization of the disease.
* Know the length of the complete or partial remission or time to disease stabilization of patients.
* Knowing the pattern of treatment that has achieved complete or partial remission or stabilization of disease and duration.
* Knowledge of overall survival.
* Knowing the toxicity of prolonged administration of trastuzumab.
* Identify the primary tumor genes HER-2 associated with such prolonged responses.

The source document will be in all cases the clinical history and in the case of patients selected for the sub-genetic analysis, the report resulting from it.

The study is carried out by filling a notebook of electronic data collection that gathers all available information contained in medical records.

The sub-genetic analysis will be performed at the Hospital de la Paz. Both, the processing of samples and conducting the analysis using qRT-PCR, will be performed in this hospital.

All data are stored, ensuring the confidentiality, security and authenticity .The forms must be reviewed by the monitor.

Once recorded the data, the database will be revised and monitored to submit those records in which there are inconsistencies or missing information . Following the closure of the database will be a report which will present the results of the analysis of the data.

Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete, Partial Remission or Stabilization of Disease During More Than 3 Years

Observational, Cross-sectional Study to Analyze the Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete Remission, Partial Remission or Stabilization of Disease During More Than 3 Years

Roche Farma, S.A

Asociación para el Progreso de la Oncología en Málaga

Docetaxel

Cetuximab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

dosage : 5mg/ml one administration per week: 400 mg/m2 then 250 mg/m2 during 18 weeks

100mg/m2 every 21 days 6 cycles of 21 days

Philippe Chollet, MD

The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination "Taxotere-Erbitux".

Assessment of the Efficacy of a Neoadjuvant Combination: "Chemotherapy-targeted Therapy" in Breast Cancer.

Phase II Pilot Study Evaluating the Neoadjuvant Combination "Taxotere (Docetaxel) and Erbitux (Cetuximab) in Operable and "Triple Negative" Breast Cancer Patients. TENEO Study.

Merck Sharp & Dohme LLC

Sanofi

Centre Jean Perrin

Indocyanine green is injected intravenously.

Intravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery

Indocyanine Green

Jean-Marie Nogaret, Prof.

Isabelle Veys, MD

Sophie VanKerckhove, biologist

Philippe De Neubourg, MD

Danielle Noterman, MD

The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue.

Primary objective:

Definition of the histological distribution (intravascular, extra vascular, in specific cells) of ICG (pre-operatively intra-venously injected) at the level of tumoral and healthy tissues of breast cancer patients (and the potential of axillary lymph nodes found fluorescent).

Secondary objectives:

Evaluation of the ability of the fluorescence imaging to determine the tumor volume and, more specifically, the boundaries of tumor tissues which will be analyzed by the pathologist.

Analysis of the correlation between fluorescence and "margins" as defined operatively as tumor (microscopically by the pathologist).

ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue.

Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.

Detecting of the fluorescence in between benign and malignant tissue by near infra-red imaging with a camera dictated to identify the margin of the tumor, and Histological detection of indocyanine green distribution in tumor bearing breasts and in axillary pieces of dissection and the detection of tumor cells in lymphe nodes.

Detecting the fluorescence in between benign and malignant tissue by a microscope with a filter for near ifra-red at a good wave length of ICG.

Jules Bordet Institute

Heart and Blood Diseases

Heart Diseases

Hormones

Anastrozole

Aromatase Inhibitors

Newly diagnosed, non-metastatic, hormone-receptor positive breast cancer patients, who have undergone lumpectomy, have been advised to not require chemotherapy, but will need to undergo radiation therapy and will be initiating therapy with anastrazole.

This study explores how aromatase inhibitor therapy affects risk factors for heart disease in postmenopausal women with breast cancer.

Frozen serum samples. No further testing planned at the moment.

The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer

National Center for Research Resources (NCRR)

Symptoms and General Pathology

Neoplasm Metastasis

Central Nervous System Depressants

Micronutrients

Vitamins

Anesthetics

Vitamin A

Retinol palmitate

Anesthetics, Local

Retinol

Patients identified by a radiologist at the time of diagnostic evaluation. Once consent is obtained, the TMEM-MRI will be scheduled. After TMEM-MRI, the patient will undergo core biopsy as per usual radiology procedure, with additional FNA at the time of core biopsy (preceding the core biopsy). MenaINV and MenaCalc will be calculated from the FNA material. After the breast biopsy confirms the suspected diagnosis of invasive breast carcinoma, the patient will be referred to breast surgery and a treatment plan devised, as per NCCN/ASCO guidelines. TMEM density, MenaCalc and MenaINV will be also calculated from the specimen obtained at the time of definitive surgery. Uth qTPERM will be correlated with TMEM density, MenaCalc and MenaINV.

Patients after breast biopsy. Once consent is obtained, patients will undergo TMEM-MRI. The patients will undergo definitive breast surgery and will receive adjuvant treatments as per NCCN/ASCO guidelines. TMEM density, MenaCalc and MenaINV will be evaluated in final surgical specimen. Uth qTPERM will be correlated with TMEM density, MenaCalc and MenaINV.

TMEM MRI INFORMATION: Unilateral breast MRI will be obtained on a 3.0T whole body MRI scanner with a dedicated breast radiofrequency coil. The patient will be scanned in the prone position with an in-dwelling IV catheter for a single dose contrast agent injection.

TMEM-MRI

FNA: The patients who are recruited prior to biopsy (Cohort A) will have had TMEM-MRI performed prior to biopsy. They will then present to radiology for ultrasound-guided core biopsy of the breast mass. FNA will be performed during this procedure. The FNA will be performed after local anesthetic is administered but prior to insertion of the core biopsy needle. FNA will be performed by the radiologist under direct sonographic visualization of the mass. Five passes will be obtained with a 25 gauge needle. The FNA material will be expelled into 1.5 ml Eppendorf tube containing phosphate buffered saline with EDTA.

Jesus Anampa, MD,MS

Jesus D Anampa, MD,MS

Karen Fehn, RN

Jesus Anampa, MD

Joseph Sparano, MD

The aim of this study is to assess feasibility of a new imaging technology in the management of breast cancer (TMEM-MRI)

The goal of this study is to assess the feasibility of a new imaging technology in the management of breast cancer. Tumor Microenvironment of Metastasis - Magnetic Resonance imaging (TMEM-MRI) has the ability to detect tumor areas with more leakiness (perfusion), where cancer cell enter blood vessels to travel to other sites. This novel TMEM-MRI has potential to be used in clinical practice to identify tumors with high leakiness that might have higher chances to recur after breast cancer treatment. In addition, TMEM-MRI can potentially be used to assess response to preoperative treatments (chemotherapy, hormonal therapy) over time.

Patients will be enrolled in 2 cohorts (A and B), based on breast biopsy status.

no need for masking, all patients will undergo TMEM-MRI

TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer

TMEM-MRI: A Pilot Feasibility Study of Magnetic Resonance Imaging for Imaging of TMEM (Tumor Microenvironment of Metastasis) in Patients With Operable Breast Cancer

Tumor permeability will be assessed by TMEM-MRI, and is defined as a number of Uth units (the number of tumor voxels with permeability density above threshold divided by the number of all tumor voxels) that will be obtained from the permeability map and TMEM-MRI algorithm.

TMEM density is defined as the number of TMEM units visualized by triple immunohistochemistry in 10 high power fields (40X). TMEM density will be measured with a fully automated and scalable clinical assay for identification and enumeration of TMEM utilizing digital pathology methods coupled with image analysis

MenaCalc is calculated by subtracting the Z-score value of Mena11a from the Z-score value of pan-Mena, obtained by quantitative immunohistochemistry in formalin-fixed paraffin-embedded breast tumor specimens. MenaCalc can also be measured by qRT-PCR in cancer cells obtained by FNA

MenaInv is calculated as pixel intensity obtained by quantitative immunofluorescence per area of formalin-fixed paraffin-embedded tumor tissue. MenaINV can also be measured by qRT-PCR in cancer cells obtained by FNA

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer	NCT04874025	Breast Cancer	Ibrance	18 Years -	Hospital San Carlos, Madrid
Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy	NCT01738685	Breast Cancer F...	Behavioral Inte... Nutritional Edu...	50 Years -	University of Pittsburgh
PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY	NCT03826979	Breast Neoplasm...	Pliates method ...	30 Years - 65 Years	Universidade Metodista de Piracicaba
Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete, Partial Remission or Stabilization of Disease During More Than 3 Years	NCT01433926	HER-2 Positive ...		18 Years -	Asociación para el Progreso de la Oncología en Málaga
Assessment of the Efficacy of a Neoadjuvant Combination: "Chemotherapy-targeted Therapy" in Breast Cancer.	NCT00600249	Breast Cancer	Cetuximab Docetaxel	18 Years -	Centre Jean Perrin
PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY	NCT03826979	Breast Neoplasm...	Pliates method ...	30 Years - 65 Years	Universidade Metodista de Piracicaba
ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue.	NCT01993576	Breast Cancer.	Indocyanine Gre...	18 Years - 65 Years	Jules Bordet Institute
The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer	NCT01080170	Breast Cancer		60 Years - 75 Years	University of Pittsburgh
Assessment of the Efficacy of a Neoadjuvant Combination: "Chemotherapy-targeted Therapy" in Breast Cancer.	NCT00600249	Breast Cancer	Cetuximab Docetaxel	18 Years -	Centre Jean Perrin
TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer	NCT03694756	Breast Cancer	TMEM-MRI FNA	18 Years -	Montefiore Medical Center
Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete, Partial Remission or Stabilization of Disease During More Than 3 Years	NCT01433926	HER-2 Positive ...		18 Years -	Asociación para el Progreso de la Oncología en Málaga
The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer	NCT01080170	Breast Cancer		60 Years - 75 Years	University of Pittsburgh

Spots Global Cancer Trial Database for breast cancer.