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Breast Cancer clinical trials

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NCT ID: NCT03329950 Completed - Breast Cancer Clinical Trials

A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies

Start date: December 1, 2017
Phase: Phase 1
Study type: Interventional

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40 antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or chemotherapy and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.

NCT ID: NCT03328169 Completed - Insomnia Clinical Trials

Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors

Start date: April 15, 2017
Phase: N/A
Study type: Interventional

Women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.

NCT ID: NCT03326713 Completed - Breast Cancer Clinical Trials

Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project

GRACE
Start date: October 1, 2016
Phase: N/A
Study type: Interventional

GRACE is a randomized 3-arm trial to determine the comparative effectiveness of two remote cancer communication interventions: 1) a targeted generic print (TP), or 2) a tailored telephone-based counseling and navigation intervention (TCN).

NCT ID: NCT03323333 Completed - Breast Cancer Clinical Trials

Psychosocial Intervention Pilot for Partners in BRCA Testing

Start date: September 4, 2014
Phase: N/A
Study type: Interventional

A brief psychosocial intervention for partners of women affected by or at risk for breast cancer and harboring BRCA genetic alterations.

NCT ID: NCT03321981 Completed - Clinical trials for Breast Cancer Metastatic

MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.

Start date: January 15, 2018
Phase: Phase 2
Study type: Interventional

A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2. MCLA-128 (zenocutuzumab) is given in combinations in two metastatic breast cancer (MBC) populations, Human Epidermal Growth Factor Receptor (HER) 2-positive/amplified (Cohort 1) and Estrogen Receptor-positive/low HER2 expression (Cohort2). Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially zenocutuzumab is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet. The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet. In Cohort 2 zenocutuzumab is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.

NCT ID: NCT03321929 Completed - Breast Cancer Clinical Trials

Intraoperative Detection of Residual Cancer in Breast Cancer

Start date: February 6, 2018
Phase: Phase 2
Study type: Interventional

This is a non-randomized, open-label, multi-site study to collect safety and efficacy data on an intraoperative imaging system, the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM imaging device), in identifying residual cancer in the tumor bed of female breast cancer patients. During the study, study physicians and clinical staff will complete hands-on training in anticipation of the upcoming pivotal study. Site-specific or user-specific issues related to the use of the device will be identified and addressed. Additionally, the data collected in the study will be used to continue training the tumor detection algorithm of the device. In this study, patients will be injected with LUM015 prior to surgery. The study physicians will perform lumpectomy procedures according to his or her institution's standard of care practice. After the main specimen removal is completed, the study physician will use the LUM Imaging Device to image the tumor bed. Therapeutic shaves will be removed based on the recommendation of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.

NCT ID: NCT03320421 Completed - Clinical trials for Breast Cancer Female

Hypofractionated Radiation Therapy With Concomitant Boost in Treating Women After Breast Conserving Surgery

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

This phase II study is to evaluate the safety of hypofractionated whole breast radiation (HFRT) with simultaneous tumor bed boost(SIB) in women with early breast cancer after breast-conserving surgery.

NCT ID: NCT03319511 Completed - Breast Cancer Clinical Trials

Thoracic Spinal Anesthesia in Awake Breast Surgery

Start date: November 24, 2014
Phase: N/A
Study type: Interventional

General anesthesia is the conventional technique used for breast surgery. breast surgery is associated with a high incidence of postoperative pain, it is estimated that over 50 % of women suffer chronic pain following breast cancer surgery. Regional anesthesia is a good alternative to general anesthesia for breast cancer surgery, providing superior analgesia and fewer side effects related to a standard opiate-based analgesia. there is no evident optimal regional techniques for operative procedures on the breast and axilla, like high thoracic epidural, cervical epidural, paravertebral block, intrerpleural block, PECs block, serratus plane block and segmental thoracic spinal anesthesia. Regional anesthesia decreases operative stress, provides beneficial hemodynamic effects especially for critically ill patients and decreases postoperative morbidity and mortality. Also it reduces post‑operative nausea and vomiting and provides prolonged post‑operative sensory block, minimizing narcotic requirements. Additionally, this application positively affects the early start of feeding and mobilization.

NCT ID: NCT03318263 Completed - Breast Cancer Clinical Trials

CIrCuLAting Dna ESr1 Gene Mutations Analysis

CICLADES
Start date: December 7, 2017
Phase: N/A
Study type: Interventional

The estrogen-dependent nature of breast cancer was first reported in 1896 with the publication of George Beatson's observations on the regression of breast cancer following oophorectomy. Endocrine therapy, targeting ER either directly by selective estrogen receptor modulators (SERMs) and pure antagonists or indirectly by aromatase inhibitors (AIs) that block estrogen production, remains the mainstay of treatment of hormone-sensitive breast cancer in the adjuvant and metastatic settings. Intrinsic (de novo) and acquired endocrine resistance constitutes an important clinical challenge in the treatment of breast cancer and multiple mechanisms are suspected to underlie the emergence of endocrine resistance. The role of the estrogen receptor (ER), encoded by the ESR1 gene, in normal mammary gland development and the progression of breast cancer is well established. ESR1 mutations, occurring in 10 to 30% of ER-positive metastatic breast cancer resistant to AIs, lead to ligand-independent activation of the ER. For patients treated with AIs, monitoring of circulating tumour DNA (ctDNA) for ESR1, PIK3CA and AKT1 mutations could permit early detection of resistance to AIs as recently reported during 2016 American Society of Clinical Oncology (ASCO) meeting.

NCT ID: NCT03316586 Completed - Breast Cancer Clinical Trials

A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer

Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

This research study is studying a combination of drugs as a possible treatment for metastatic triple-negative breast cancer. The drugs involved in this study are: - Cabozantinib (XL184) - Nivolumab