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Breast Neoplasms clinical trials

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NCT ID: NCT02743858 Recruiting - Breast Cancer Clinical Trials

Lymphedema Surveillance Study

Start date: April 2016
Phase:
Study type: Observational

This study is being done to find out how many women develop lymphedema after an axillary lymph node dissection. The investigators also want to look for reasons why some women get lymphedema and others don't. Specifically, the investigators want to do tests on the breast tissue that is removed at the time of surgery to see if they can identify inflammation in the breast tissue, which may increase a woman's risk for lymphedema. The investigators will also ask the patient to answer questions to see how much their quality of life is affected by lymphedema, and whether this study can help women by detecting lymphedema earlier.

NCT ID: NCT02742168 Completed - Breast Cancer Clinical Trials

99mTc-3PRGD2 SPECT/CT in Breast Cancer Patients

Start date: January 2016
Phase: N/A
Study type: Interventional

This is an open-label SPECT/CT (single photon emission computed tomography / computed tomography) study to investigate clinical study of 99mTc-3PRGD2 SPECT/CT in diagnosis and efficacy evaluation of breast cancer. Diagnostic group: for patients in suspicion of breast cancer. The standard of truth for diagnosis was based on histopathologic findings after surgical removal of the tumor or a definite diagnosis from fine needle aspiration biopsy. A single dose of nearly 0.3 mCi/kg (milli-Curie/kilogram) body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients. Visual and semiquantitative method will be used to assess the whole-body planar and lesions SPECT/CT images. Efficacy evaluation group: for patients firstly diagnose with malignant tumors (breast cancer), and prepare to chemotherapy(including neoadjuvant chemotherapy) or radiotherapy. The standard of truth for diagnosis was based on histopathologic findings after fine needle aspiration biopsy. A single dose of nearly 0.3 mCi/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients before treatment, the second period, sixth period. Visual,semiquantitative method will be used to assess the whole-body planar and lesions SPECT/CT images. By comparing with result of the other related imaging, for instance, PET/CT (positron emission tomography/computed tomography), CT (computed tomography), MRI (magnetic resonance imaging), Doppler Ultrasound, Mammography, etc.

NCT ID: NCT02742051 Completed - Breast Cancer Clinical Trials

A Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer

Start date: June 2016
Phase: Phase 2
Study type: Interventional

This open, randomized pilot feasibility trial is to evaluate the feasibility and effect of neoadjuvant everolimus plus letrozole versus neoadjuvant fluorouracil, epirubicin plus cyclophosphamide (FEC) in treating postmenopausal women with ER-positive, HER2-negative breast cancer. Forty postmenopausal stage M0, ER-positive, HER2-negative invasive breast cancer women who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging were randomly (1:1) enrolled to receive neoadjuvant everolimus plus letrozole for 18 weeks or neoadjuvant FEC for 6 cycles before surgery. The primary objective is to determine the feasibility of neoadjuvant everolimus plus letrozole in postmenopausal patients with ER-positive, HER2-negative breast cancer. Secondary aims are to compare the ultrasound response rate, pathological complete response (pCR) rate, breast-conserving surgery rate, toxicities, and changes in the percentages or counts of peripheral blood CD4+ T cells, CD8+ T cells, tumor-specific CTLs, T helper cells (Th), regulatory T cells (Treg), and NK cells and changes in tumor Ki67 index (pre- versus post- neoadjuvant therapy).

NCT ID: NCT02740491 Completed - Breast Neoplasms Clinical Trials

Implementation of a "Remission" Consultation in the Management of Patients Treated for Localized Breast Cancer

REVIS
Start date: September 12, 2016
Phase:
Study type: Observational

The main objective of this study is to describe the evolution in quality of life (QLQ-C30) for patients receiving breast cancer care at 3, 6 and 12 months after a "remission" consultation.

NCT ID: NCT02738970 Completed - Early Breast Cancer Clinical Trials

A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)

Start date: June 23, 2016
Phase: Phase 1
Study type: Interventional

This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta. Exposure between SC Perjeta and IV Perjeta will be compared using a compilation of pharmacokinetic (PK) parameters such as area under the concentration-time curve (AUC), maximum serum concentration (Cmax), time of maximum concentration (Tmax), and serum trough concentration (Ctrough). Part 2 is designed to confirm the dosing regimen in women with EBC on the basis of safety, tolerability, and PK assessments.

NCT ID: NCT02738866 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor

Start date: October 25, 2016
Phase: Phase 2
Study type: Interventional

This study is being done to look at the role of continuing palbociclib treatment in combination with another type of hormonal therapy (fulvestrant) after disease progression of palbociclib in combination with an aromatase inhibitor.

NCT ID: NCT02735668 Completed - Breast Cancer Clinical Trials

Physiotherapy in Women With Peripheral Persistent Pain Following Breast Cancer Treatment

Start date: April 2016
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effectiveness of a multimodal physiotherapy intervention including scapula exercises in addition to deep dry needling and neurodynamic techniques versus scapula exercises only versus conventional shoulder exercises on pain intensity, perceived disability, scapula muscle activity and health-related quality of life.

NCT ID: NCT02734615 Terminated - Clinical trials for Advanced or Metastatic ER+ Breast Cancer

Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

Start date: June 14, 2016
Phase: Phase 1
Study type: Interventional

To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine therapy.

NCT ID: NCT02734290 Active, not recruiting - Clinical trials for Triple Negative Breast Cancer

Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer

Start date: February 23, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this study is to establish the safety and tolerability of pembrolizumab when administered in combination with either of two chemotherapy regimens (weekly paclitaxel or capecitabine) in unresectable/metastatic triple negative breast cancer (MTNBC) patients.

NCT ID: NCT02733601 Completed - Breast Cancer Clinical Trials

Epidemiology of Breast Cancer in Women Based on Diagnosis Data From Oncologists and Breast Surgeons in Algeria

BreCaReAl
Start date: May 29, 2016
Phase:
Study type: Observational [Patient Registry]

National, prospective, multicentre, non-interventional epidemiological study, conducted among oncologists and breast surgeons in community and university hospitals, from the public sector in Algeria. The study will collect information on the characteristics, and breast carcinomas patterns of patients whose breast cancer diagnosis was confirmed by an anatomopathologist. The study will be conducted over a representative, but not exhaustive sample of Algerian female patients.