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Breast Cancer clinical trials

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NCT ID: NCT03846583 Not yet recruiting - Breast Cancer Clinical Trials

Tucatinib + Abemaciclib + Herceptin for HER2+ MBC

Start date: February 28, 2019
Phase: Phase 1
Study type: Interventional

This research study is studying a combination of drugs as a possible treatment for HER2-Postive Metastatic Breast Cancer. The interventions involved in this study are: - Tucatinib - Abemaciclib (VerzenioTM) - Trastuzumab (Herceptin®) - Endocrine Therapy: Exemestane (Aromasin®), Letrozole (Femara®), or Anastrozole (Arimidex®)

NCT ID: NCT03846167 Not yet recruiting - Breast Cancer Clinical Trials

Imaging of Primary or Recurrent Breast Cancer With 18F-FluorThanatrace PET/CT

FTT 2
Start date: February 2019
Phase:
Study type: Observational

Patients with known or suspected, in the opinion of an investigator, primary or metastatic breast cancer may be eligible for this study. Up to 30 evaluable patients will undergo study imaging in this protocol. The imaging procedure may include one or both of the following imaging sessions; 1) a 45- 60 minute dynamic scan, starting at approximately the same time as the injection and/or 2) a skull base to mid-thigh scan starting approximately 60 minutes post injection of [18F]FTT. The planned scanning protocol will be selected by an investigator and will be discussed with the subject prior to the imaging visit. The PET/CT scan will include an injection of [18F]FTT. Data will be collected to evaluate uptake of [18F]FTT in breast cancer and compare with PARP-1 activity in tissue, when available. If patients are getting neoadjuvant or other systemic therapy, a second optional scan may be performed 1 day to 3 weeks after therapy begins to evaluate whether response correlates with increase in PARP-1 activity.response correlates with increase in PARP-1 activity.

NCT ID: NCT03841747 Not yet recruiting - Breast Cancer Clinical Trials

Paclitaxel Plus Pembrolizumab vs. Paclitaxel Weekly in ER+ Luminal B Metastatic Breast Cancer

PELICAN
Start date: May 2019
Phase: Phase 2
Study type: Interventional

PELICAN is a randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic ER-positive, HER2-negative, Luminal B breast cancer who have received no prior chemotherapy for advanced or metastatic disease. Patients will be randomised (2:1) to one of the two treatment arms: - Pembrolizumab plus Paclitaxel - Paclitaxel

NCT ID: NCT03840200 Not yet recruiting - Breast Cancer Clinical Trials

A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer.

Start date: March 22, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a study in participants with advanced breast, ovarian, or prostate cancer to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of ipatasertib in combination with rucaparib. The study consists of two parts: a Dose-Escalation Phase (Part 1) in participants with previously treated advanced breast cancer, ovarian cancer, or prostate cancer and a Dose-Expansion Phase (Part 2) in participants with advanced prostate cancer who have had at least one line of prior therapy with second-generation androgen-receptor (AR)-targeted agents (e.g., abiraterone, enzalutamide, apalutamide).

NCT ID: NCT03839823 Not yet recruiting - Breast Cancer Clinical Trials

Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer

RIGHT Choice
Start date: February 28, 2019
Phase: Phase 2
Study type: Interventional

To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer

NCT ID: NCT03838549 Not yet recruiting - Breast Cancer Clinical Trials

Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy

MRIMOP
Start date: February 2019
Phase: N/A
Study type: Interventional

Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.

NCT ID: NCT03838419 Not yet recruiting - Breast Cancer Clinical Trials

Intraoperative Electron Radiotherapy for Low-risk Early Breast Cancer

COSMOPOLITAN
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Breast cancer is the most frequent malignancy in women. Standard therapy for early-stage breast cancer is breast conserving surgery (BCS) followed by adjuvant whole breast irradiation (WBI), which usually requires a treatment time of 3-6 weeks. Several randomized controlled trials (RCTs) demonstrated that postoperative WBI after BCS significantly decreased the risk of local (in-breast) recurrence and improved breast cancer mortality as well as survival. However, one of the most common side-effects of radiotherapy is fatigue, which is reported in up to 80% of cancer patients during treatment. Especially in early-stage breast cancer patients it might be the only serious side-effect following adjuvant irradiation, as fatigue often significantly reduces quality of life due to resulting functional impairment and psychological distress. Fatigue additionally has a distinct socioeconomic impact: 75% of patients and 40% of caregivers are forced to change their employment status due to cancer-related fatigue. For reducing treatment-related toxicity, several RCTs consequently addressed the question whether adjuvant WBI could be omitted in early-stage, low risk breast cancer patients treated with endocrine therapy. However, all these trials detected up to seven-time increased local recurrence rates without WBI following BCS. Both, longer duration of radiotherapy and larger radiation field sizes are known to be associated with increase in treatment-related fatigue. Accelerated partial breast irradiation (APBI), delivered exclusively to the original tumor location and not to the surrounding breast tissue, might therefore be an alternative treatment option with fewer side-effects for early-stage, low risk breast cancer patients. Few previous trials have already reported comparable outcomes for highly selected low-risk breast cancer patients for APBI compared to conventional WBI. First results also point out that APBI compared to WBI might be associated with less severity and intensity of fatigue. One method for APBI is single-dose intraoperative radiotherapy (IORT) delivered directly to the tumor after resection. Data is still limited for APBI, hence current international and German guidelines suggest the use of APBI for low-risk early stage breast cancer patients but recommend the application of APBI preferably within a clinical trial.

NCT ID: NCT03835897 Not yet recruiting - Breast Cancer Clinical Trials

Breast Cancer Screening With Diffusion-weighted MRI in Women at High Risk for Breast Cancer

Start date: March 2019
Phase:
Study type: Observational

A prospective observational multicenter study to compare the outcome of breast cancer surveillance using mammography, breast US, contrast-enhanced MRI, and diffusion-weighted MR imaging (DWI) as a screening tool, in the high-risk women for breast cancer. - Primary objective: To compare the sensitivity of mammography, breast US, contrast-enhanced MRI, and DWI for the detection of breast cancer - Secondary objective: 1. To compare the specificity of mammography, breast US, contrast-enhanced MRI, and DWI for the detection of breast cancer 2. To compare the cancer detection rate of mammography, breast US, contrast-enhanced MRI, and DWI 3. To compare the characteristics of detected cancers

NCT ID: NCT03833726 Not yet recruiting - Breast Cancer Clinical Trials

Light Emitting Diode for theTreatment of Genitourinary Syndrome of Menopause Associated With Breast Cancer Treatment

LEDCA
Start date: January 30, 2019
Phase: N/A
Study type: Interventional

Breast Cancer treatment may cause several side effects, some long lasting. Adjuvant hormone therapy helps avoiding recurrence triggers vulvovaginal atrophy syndrome. This study evaluate a photodynamic treatment with light emitting diode to improve vaginal dryness and irritation, pruritus, pain or discomfort in intercourse.

NCT ID: NCT03832920 Not yet recruiting - Breast Cancer Clinical Trials

Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure

ANIBPV
Start date: February 2019
Phase:
Study type: Observational [Patient Registry]

Paravertebral Block (PVB) combined with general anesthesia (GA) is a conventional pain treatment for breast surgery but sometimes failures can occurs. The efficacy of this block has to be evaluated. Also, for the intra-operative analgesic evaluation of this block, it is necessary to measure intra-operative analgesia index. A monitor of nociception for patients under GA, the PhysiodolorisTM device, offers an index for measuring nociceptive inputs during surgery in anesthetized patients : the ANI index (based on the single R-R interval analysis). The purpose of this observational and prospective study is to assess the variations of this ANI index during breast surgery with or without axillary node dissection with a PVB. This will allow us to quantify the analgesic effect of a PVB during GA for unilateral radical breast surgery with or without axillary node dissection.