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Breast Neoplasms clinical trials

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NCT ID: NCT03988114 Withdrawn - Clinical trials for Metastatic Breast Cancer

A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer

proMONARCH
Start date: September 16, 2019
Phase: Phase 4
Study type: Interventional

The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) advanced breast cancer that have certain disease characteristics.

NCT ID: NCT03981718 Withdrawn - Breast Cancer Clinical Trials

Adipose-Induced Regeneration of Breast Skin to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients

Start date: May 17, 2019
Phase: N/A
Study type: Interventional

Researchers are trying to identify the therapeutic effect of injection into the subcutaneous tissue to treat radiation-induced skin injury of post mastectomy in patients with breast cancer.

NCT ID: NCT03974204 Withdrawn - Breast Cancer Clinical Trials

Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.

Start date: July 2019
Phase: N/A
Study type: Interventional

This is a multicenter, interventional, prospective study among breast cancer patients with a suspicion of metastatic meningitis. The current study aims to assess the use of proteomic profile issued from cerebrospinal fluid microvesicles for diagnosis of leptomeningeal metastases.

NCT ID: NCT03940248 Withdrawn - Breast Cancer Clinical Trials

Proton Accelerated Partial Breast Irradiation

APBI
Start date: July 1, 2020
Phase: Phase 2
Study type: Interventional

This prospective, non-randomized phase II study will evaluate the cosmetic outcome of using pencil beam scanning proton therapy for partial breast irradiation in patients diagnosed with early stage breast cancer. In addition the study will evaluate the acute and late toxicities, and the rates of ipsilateral breast tumor recurrence, both in situ and invasive disease. To qualify for the trial, patients must be 50 years or older and have stage 0 (carcinoma in situ) or stage IA or IIA invasive carcinoma of the breast with no evidence of metastatic disease. The tumor size must be 3cm or less. Women must have undergone a partial mastectomy with margins free of invasive cancer and at least a 2mm margin for in situ disease. Patients must have clinically node negative disease. Patients with invasive disease must also have nodal assessment performed with either sentinel lymph node biopsy or axillary lymph node dissection and patients must have pathologically node negative disease. Accelerated partial breast irradiation (APBI) will utilize pencil beam scanning proton therapy. Partial breast irradiation will be delivered twice a day, at least 6 hours apart, over 5 treatment days. This trial is designed to accrue 21 patients over a period of three years.

NCT ID: NCT03872505 Withdrawn - Breast Cancer Clinical Trials

Pre-operAtive Non-Anthracycline Chemotherapy, Durvalumab +/- RAdiation Therapy in Triple Negative Breast Cancer

PANDoRA
Start date: July 2022
Phase: Phase 2
Study type: Interventional

This phase II randomized trial is for patients with clinical stage II-III, ER and PR <10%, HER2-negative invasive breast carcinoma (triple negative breast cancer) for whom adjuvant RT is planned and pre-operative RT is deemed feasible by the treating radiation oncologist. Subjects will be randomized into arm A or B and treatment will last for 16 weeks. Both groups will receive Durvalumab 750mg IV Q2 weeks x 2 then a biopsy prior to durvalumab 1500mg IV Q4 weeks x 3 with paclitaxel and carboplatin IV weekly x 12. Arm B will receive radiation (24 Gy total) starting with the second durvalumab dose every other day (8Gy per fraction) for one week. Following treatment, subjects will receive SOC breast surgery and continue on to physician's choices SOC treatment during the 3 year follow up period. This study hopes to explore the impact of checkpoint blockade administration with a non- anthracycline chemotherapy regimen plus RT on post-surgery pathologic complete response (pCR) rate in the breast and axilla (ypT0/Tis ypN0) following 12 weeks of treatment and surgery.

NCT ID: NCT03863301 Withdrawn - Breast Cancer Clinical Trials

MRI-guided Single Dose Preoperative Radiotherapy in Low-risk Breast Cancer

ABLATIVE-2
Start date: March 4, 2019
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the pathologic response at 12 months after single dose preoperative partial breast irradiation in early stage breast cancer patients. Furthermore, the aim is to collect data on response monitoring. Patient-reported outcome measures and treatment-induced toxicity will be evaluated.

NCT ID: NCT03846583 Withdrawn - Breast Cancer Clinical Trials

Tucatinib + Abemaciclib + Herceptin for HER2+ MBC

Start date: June 28, 2020
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: NCT03841747 Withdrawn - Breast Cancer Clinical Trials

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

PELICAN
Start date: December 2020
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: NCT03811418 Withdrawn - Clinical trials for HER2-positive Breast Cancer

A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer

ATTILA
Start date: January 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first.

NCT ID: NCT03811262 Withdrawn - Breast Cancer Clinical Trials

Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period. PECS II block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery. ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this technique in breast surgery to provide analgesia but to date no studies comparing these technique exists. Our hypotesis is that this two technique are equally able to provide analgesia in breast surgery. Study type: RCT, single blind.