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Breast Neoplasms clinical trials

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NCT ID: NCT02540330 Terminated - Clinical trials for Female Breast Carcinoma

A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant

007
Start date: March 2016
Phase: Phase 2
Study type: Interventional

This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All subjects will be monitored for systemic and local adverse events during the procedure, and following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels.

NCT ID: NCT02540083 Terminated - Breast Cancer Clinical Trials

Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography

ADAPT-ENRICH
Start date: August 2015
Phase: N/A
Study type: Interventional

The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for clinically indicated breast biopsy based on suspicious DBT screening breast imaging results. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other performance measures.

NCT ID: NCT02539017 Withdrawn - Clinical trials for Triple Negative Breast Neoplasms

The Clinical Significance of Cellular Immune Adjuvant Therapy of Triple Negative Breast Cancer

Start date: November 2015
Phase: Phase 2
Study type: Interventional

As a special type of breast cancer, the triple negative breast cancer has the characteristics of high recurrence rate (2 years after surgery), high distant metastasis rate, poor prognosis and short survival time. No matter at home or abroad, the clinical researches of the triple negative breast cancer are mainly focused on finding new drugs and new treatment strategies in order to reduce its recurrence and distant metastasis rate. The DC/CIK cell immunotherapy combined with chemotherapy in the clinical study of metastatic triple negative breast cancer has already confirmed benefit. This study is based on the theory that the optimal timing of cellular immunity is while the host tumor load is under the smallest state. Put forward the hypothesis that the DC/CIK cell immunotherapy combined with chemotherapy may improve the disease-free survival and overall surviva after the triple negative breast cancer operation. The investigators intends to use the RCT, observing the clinical significance of cellular immune adjuvant therapy of triple negative breast cancer in 340 patients with TNBC. Do the safety evaluation of cellular immunity in the adjuvant treatment of breast cancer treatment, explore the clinical strategies for breast cancer immunotherapy.

NCT ID: NCT02538484 Completed - Breast Cancer Clinical Trials

Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects

Start date: April 2016
Phase: Early Phase 1
Study type: Interventional

Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.

NCT ID: NCT02538471 Terminated - Clinical trials for Metastatic Breast Cancer

LY2157299 Monohydrate (LY2157299) and Radiotherapy in Metastatic Breast Cancer

Start date: August 10, 2015
Phase: Phase 2
Study type: Interventional

Patients with metastatic breast cancer receiving at least one single agent chemotherapy and demonstrating stable disease or disease progression at two consecutive clinical/radiological assessments (at an interval of at least 2 weeks). Transforming growth factor-beta (TGFΒ) blockade will enhance response of irradiated tumors and improve the function of Dendritic and T cells. Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle). Radiation to a metastatic site will be delivered at a dose of 7.5 Gy, given consecutively on days 1-3-5.

NCT ID: NCT02536794 Completed - Clinical trials for Stage IV Breast Cancer

MEDI4736 and Tremelimumab in Treating Patients With Metastatic HER2 Negative Breast Cancer

Start date: January 14, 2016
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to determine the anti-tumor activity of MEDI4736 in combination with tremelimumab in patients with metastatic HER2-negative breast cancer. Both MEDI4736 and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). MEDI4736 attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by inhibiting a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may result in better treatment options for patients with breast cancer.

NCT ID: NCT02536742 Completed - Clinical trials for Metastatic Breast Cancer

Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer

PYTHIA
Start date: August 30, 2016
Phase: Phase 2
Study type: Interventional

This international, multicenter, prospective single arm Phase II biomarker discovery clinical trial with the primary objective of assessing the association of PFS with gene mutations, gene copy number aberrations and gene signatures in post-menopausal women with hormone receptor positive, HER2-negative metastatic or locally relapsed breast cancer whose disease has progressed after prior adjuvant endocrine therapy or one line systemic treatment, i.e., endocrine treatment or chemotherapy, administered for metastatic disease.

NCT ID: NCT02536625 Completed - Breast Cancer Clinical Trials

Study of the Impact of Everolimus Treatment on Lymphocytes NK (Natural Killer) Development and Functions for Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative)

RAPANK
Start date: October 2015
Phase:
Study type: Observational

NK (Natural Killer) cells are important in the fight against tumor, especially for the control of cancer metastasis. The purpose of this prospective study is to evaluate the impact on lymphocytes NK functions and development of an everolimus treatment in women treated for a metastatic breast cancer. In particular, the study of lymphocytes NK functions and development under everolimus treatment could permit to validate an early biomarker of the impact of everolimus on these NK cells.

NCT ID: NCT02536339 Completed - Clinical trials for Metastatic Breast Cancer

A Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy

Start date: December 16, 2015
Phase: Phase 2
Study type: Interventional

This study will examine the safety and efficacy of pertuzumab in combination with high-dose trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease progression in the brain following radiotherapy.

NCT ID: NCT02535221 Recruiting - Breast Cancer Clinical Trials

Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

Start date: July 29, 2015
Phase: Phase 3
Study type: Interventional

This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.