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Breast Neoplasms clinical trials

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NCT ID: NCT03634150 Withdrawn - Clinical trials for Triple Negative Breast Cancer

Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer

Start date: September 6, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b, open-label, non-randomized, Dose Confirmation study. Subjects will be treated, once a week, with IV doses of Nerofe and low dose (20 mg/m2) Doxorubicin (6-8 hours from one another) in consecutive, 28-day cycles.

NCT ID: NCT03611985 Withdrawn - Breast Cancer Clinical Trials

Phase I/IIa Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients

Start date: March 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with breast cancer are commonly treated with taxane chemotherapy. Some very common side effects of taxanes, such as anemia and peripheral neuropathy, are often as not well addressed during treatment, resulting in dose reductions, dose delays and early discontinuation (collectively called relative dose intensity) of these chemotherapy agents in 15-80 % of patients on these drugs. This reduction in relative dose intensity (RDI) results in worse clinical outcomes such as progression free and overall survival. Pre-clinical studies in mouse models subjected to standardized chemotherapy regimens containing paclitaxel or oxaliplatin have shown that the nutritional supplement Epidiferphane™ reduces both neuropathy and anemia. This study will investigate whether the use of Epidiferphane™ in patients with breast cancer receiving taxane chemotherapy results in an attenuation of the side effects experienced, as well as an improvement in tumor response rate. The safety and maximum tolerated dose of Epidiferphane™ in this patient population will also be determined in this study.

NCT ID: NCT03563352 Withdrawn - Cholangiocarcinoma Clinical Trials

Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer

Start date: August 30, 2018
Phase:
Study type: Observational

This trial studies nutritional preferences and product accessibility in oral nutritional supplements in participants with breast, colorectal, upper gastrointestinal, or prostate cancer. Learning what participants like and dislike about their current or past used nutritional supplements may help doctor know how to improve them.

NCT ID: NCT03554109 Withdrawn - Clinical trials for Triple Negative Breast Cancer (TNBC)

QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine

TNBC
Start date: September 2018
Phase: Phase 2
Study type: Interventional

This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).

NCT ID: NCT03532087 Withdrawn - Breast Neoplasms Clinical Trials

Study to Identify the Impact of Denosumab on the Immune System in Patients With HER2 Negative Breast Cancer

PERIDENO
Start date: February 2018
Phase: Phase 2
Study type: Interventional

The aim of this prospective, randomized, multicenter, open-label, explorative phase II study is to identify the impact of (neo)adjuvant denosumab on the systemic immunity and local immunologic microenvironment in postmenopausal patients with HER2 negative non-metastatic primary breast cancer.

NCT ID: NCT03524261 Withdrawn - Clinical trials for Advanced Breast Cancer

Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Breast Cancer

Start date: May 20, 2019
Phase: Phase 2
Study type: Interventional

This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1 bispecific antibody for advanced breast cancer. And the aim of this research is to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1 bispecific antibody for breast cancer.

NCT ID: NCT03523299 Withdrawn - Clinical trials for Invasive Ductal Carcinoma, Breast

Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer

Start date: May 22, 2018
Phase: N/A
Study type: Interventional

This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group. Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.

NCT ID: NCT03511079 Withdrawn - Breast Cancer Clinical Trials

Music as a Perioperative Therapy in Breast Cancer Patients

Start date: July 10, 2019
Phase: N/A
Study type: Interventional

Music has often been used in hospitals as a therapy but there is a limited amount of research looking at how music actually affects the different molecules in the body, such as cortisol (a marker of stress). There is especially a lack of research in the context of surgery. The hope is that this study will show that music can be used to minimize some of the side effects related to breast surgery and improve the patient experience.

NCT ID: NCT03473691 Withdrawn - Clinical trials for Triple Negative Breast Cancer

Pilot Study of Glembatumumab Vedotin Following Doxorubicin and Cytoxan as Neo-adjuvant Therapy in Gp-NMB-expressing High Risk Triple Negative Breast Cancer

Breast50
Start date: May 1, 2018
Phase: Early Phase 1
Study type: Interventional

This is a single arm, pilot study assessing safety/feasibility and efficacy of neo-adjuvant glembatumumab vedotin (GV) in patients with high risk triple negative breast cancer (TNBC) with glycoprotein-NMB (gpNMB) expression ≥ 25%. Primary endpoints will be safety/feasibility, and secondary endpoints will be rates of pathologic complete response (pCR), and measurements of growth differentiation factor-11 (GDF11) and glycoprotein NMB (gpNMB) expression.

NCT ID: NCT03437915 Withdrawn - Breast Cancer Clinical Trials

BrUOG 351: PRE-OPERATIVE APBI USING NIBB

351
Start date: March 2019
Phase: N/A
Study type: Interventional

Partial breast irradiation is typically performed after surgical removal of the tumor. Partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing breast tissue from the potential bad effects of radiation compared to radiating the whole breast, which was the standard of care for many years. This study is evaluating the use of partial breast irradiation with NIBB performed before surgery instead of after surgery.This should allow researchers to target the cancer even more accurately and result in less normal breast tissue receiving radiation which may cause less side effects and/or a better cosmetic outcome. In this study partial breast treatment will be given with NIBB in 5 treatments over about 1 week. Surgical removal of the tumor will then be performed between 4-12 weeks following radiation treatment. Researchers believe that participant's risk of complications from surgery will not be higher after getting these radiation treatments than it would have been if participants had surgery first, but that is one of the things researchers are studying.