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Breast Neoplasms clinical trials

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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: NCT02531425 Completed - Clinical trials for ER-Negative PR-Negative HER2-Negative Breast Cancer

Evaluation of Pharmacodynamic Effects of IT-pIL12-EP in Patients With TNBC

TNBC
Start date: September 2015
Phase: Phase 1
Study type: Interventional

Intratumoral plasmid IL-12 electroporation (IT-pIL12-EP) will be administered to approximately 10 patients with triple negative breast cancer (TNBC) with cutaneous or subcutaneous disease. Patients will receive one complete cycle of therapy, consisting of local injection of plasmid IL-12 (pIL-12) followed immediately by electroporation (EP), into accessible tumor lesions. IT-pIL12-EP will be administered in Days 1, 5, and 8 of the single 28-day cycle.

NCT ID: NCT02530424 Completed - Breast Neoplasms Clinical Trials

"Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment "

NA-PHER2
Start date: May 2015
Phase: Phase 2
Study type: Interventional

This is a multicenter neoadjuvant trial conducted under the sponsorship and overall trial management of the Fondazione Michelangelo in Italy. Women with a diagnosis of invasive unilateral non metastatic ER-positive breast cancer expressing HER2 and suitable for neoadjuvant therapy Patients in this study will receive: Trastuzumab+Pertuzumab+Palbociclib with or without Fulvestrant (HPPF) Trastuzumab 8 mg/kg loading dose IV, then 6 mg/kg IV q.3 wks (repeat for a total of 6 administrations) Pertuzumab 840 mg loading dose IV, then 420 mg IV q. 3 wks (repeat for a total of 6 administrations) Palbociclib 125 mg po q.d. x 21 q. 4 wks (= 1 cycle; repeat for a total of 5 cycles) Fulvestrant will be given intra-muscle at the dose of 500 mg every 4 weeks (repeat for 5 times) with an additional 500 mg dose given two weeks after the initial dose (total administrations including the additional one = 6) The total duration of neoadjuvant palbociclib (5 cycles every 4 weeks) and fulvestrant (5 administrations every 4 weeks plus the additional dose given two weeks after the initial dose) was selected to match as closely as possible the total duration of the six planned 3-weekly administrations of trastuzumab and pertuzumab Definitive surgery will be performed not earlier than 14 days and not later than 28 days after the last dose of any of the drugs in the combination reported above After completion of the neoadjuvant and surgical treatment patients will receive irradiation as locally acceptable. Patients will also continue to receive systemic drug therapy including chemotherapy (plus standard anti-HER2 treatment until completion of full 1 year if HER2 3+ or neu amplified, i.e. cohorts A and B) and endocrine therapy according to local guidelines at the Investigator's discretion.

NCT ID: NCT02529280 Completed - Breast Cancer Clinical Trials

Choices for Latinas and Clinical Trials

Start date: February 2012
Phase: N/A
Study type: Interventional

"Increasing Access of Latinas into Breast Cancer Clinical Trials" aims to develop and pilot test a multi-communications approach - using a culturally relevant computer video, a tailored booklet and a patient navigator (PN) - to empower Latinas to make informed decisions about breast cancer clinical trials (BCCTs). Latinos represent 15% of the U.S. population but only 5.6% of participants in National Cancer Institute (NCI) treatment clinical trials, resulting in disparities in cancer outcomes and jeopardizing the generalizability of trial findings. In response, this study will develop and evaluate communication and health-system-change strategies to facilitate Latinas' access to BCCTs at the Cancer Therapy and Research Center at The University of Texas Health Science Center at San Antonio (CTRC-UTHSCSA). The CTRC-UTHSCSA, an NCI-designated Cancer Center located in South Texas, serves a culturally and ethnically diverse population that historically has low participation in clinical trials, especially among those with breast cancer, the No. 1 cancer killer of Latinas.

NCT ID: NCT02528747 Completed - Clinical trials for Metastatic Breast Cancer

A Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate

Start date: January 2009
Phase: N/A
Study type: Observational

This observational, multicenter survey is designed to assess the efficacy of oral ibandronate in adults with breast cancer and metastatic bone disease. Data on the use of ibandronate in clinical practice will be collected from Hungarian patients.

NCT ID: NCT02527889 Completed - Breast Cancer Clinical Trials

The Effect of Resistive Exercise on Forearm Blood Flow and Tissue Oxygenation Among Breast Cancer Survivors With or at Risk for Breast Cancer-related Lymphoedema (BCRL)

Start date: July 2015
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the effect of resistive exercise on forearm blood flow and tissue oxygenation among breast cancer survivors with or at risk for breast cancer-related lymphoedema (BCRL).

NCT ID: NCT02527746 Completed - Breast Cancer Clinical Trials

Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Start date: December 2012
Phase: Phase 1
Study type: Interventional

A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg.

NCT ID: NCT02527317 Completed - Breast Cancer Clinical Trials

Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer

Start date: January 2015
Phase: N/A
Study type: Observational

This is a prospective, non-interventional, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with lipegfilgrastim support in early breast cancer.

NCT ID: NCT02526498 Completed - Clinical trials for Invasive Breast Carcinoma

Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery

TRIUMPH-T
Start date: July 15, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has not spread beyond the breast or the axillary lymph nodes (early-stage) after surgery. Radiation therapy uses a type of energy to kill cancer cells and shrink tumors. Brachytherapy is a type of internal radiation therapy that provides radiation inside the breast to any remaining tumor cells next to the space where the tumor was removed, and is given over a shorter amount of time than standard radiation therapy. Giving accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy may reduce the overall time that radiation is delivered to the tumor cells.

NCT ID: NCT02524561 Completed - Clinical trials for Mammographic Density

KEEPS Mammographic Density And Breast Health Ancillary Study

KEEPS MDBHAS
Start date: September 2005
Phase: N/A
Study type: Interventional

Combined estrogen and progestin therapy has been shown to increase mammographic density and incidence of breast cancer in randomized trials. We propose to examine the effects of now commonly used low-dose combined hormone therapy (HT) regimens on breast density, rates of abnormal mammogram, and circulating estrogens in the ongoing, already-funded Kronos Early Estrogen Prevention Study (KEEPS). KEEPS is a randomized clinical trial with a primary goal of examining the effects of low-dose transdermal versus oral estrogen combined with cyclic micronized progesterone on progression of subclinical atherosclerosis in recently menopausal women. Prior studies of low-dose HT have been of short duration and small size. By determining the effects of low-dose hormone therapy on the breast, the proposed ancillary study will add important information about the estimated balance of risks and benefits associated with low-dose HT and will help guide future research trials.