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Metastatic Breast Cancer clinical trials

View clinical trials related to Metastatic Breast Cancer.

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NCT ID: NCT04296942 Terminated - Breast Cancer Clinical Trials

BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)

Start date: May 4, 2021
Phase: Phase 1
Study type: Interventional

Background: Breast cancer is the second most common cause of United States (U.S.) cancer deaths in women. Immunotherapy drugs use a person's immune system to fight cancer. Researchers want to see if a new combination of immunotherapy drugs can help treat breast cancer that has gone to places in the body outside of the breast (metastasized). Objective: To learn if a new combination of immunotherapy drugs can shrink tumors in people with metastatic breast cancer. Eligibility: Adults 18 and older who have been diagnosed with metastatic breast cancer, such as Triple Negative Breast Cancer (TNBC) or estrogen receptors (ER)-/progesterone receptors (PR)-/human epidermal growth factor receptor 2 (HER2)+ Breast Cancer (HER2+BC) Design: Participants will be screened with: medical history physical exam disease confirmation (or tumor biopsy) tumor scans (computed tomography, magnetic resonance imaging, and/or bone scan) blood and urine tests electrocardiogram (measures the hearts electrical activity) echocardiogram (creates images of the heart). Participants will be assigned to 1 of 3 groups. The drugs they get will be based on the group they are in. Drugs are given in cycles. Each cycle = 3 weeks. Participants will be seen in clinic every 3 weeks, prior to the start of a new cycle. At each visit, participants will have an clinical exam, have blood drawn and will be asked about any side effects. They will repeat the screening tests during the study. New scans, like a computed tomography (CT) scan, will be done every 6 weeks to see if the treatment is working. All participants will get Bavarian Nordic (BN)-Brachyury. It is 2 different vaccines - a prime and a boost. First the priming vaccines, called MVA-BN-Brachyury help to jump start the immune system. Next the boosting vaccines, called fowlpox virus (FPV)-Brachyury help to keep the immune system going. They are injected under the skin during different cycles. All participants will get M7824 (also known as Bintrafusp alfa), which is an immunotherapy drug. Some participants will get a commonly used drug is HER2+ breast cancer called adotrastuzumab emtansine (also known as T-DM1DM1 or kadcyla). For both, a needle is inserted into a vein to give the drugs slowly. Some participants will take Entinostat weekly by mouth. It is in tablet form. Participants will keep a pill diary. Participants will continue on their assigned treatment until their cancer grows, they develop side effects or want to stop treatment. About 28 days after treatment ends, participants will have a follow-up visit or a telephone call. Then they will be contacted every 3 months for 1 year, then every 6 months for 1 year. They may have more tumor scans or continue treatment.

NCT ID: NCT04293276 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Study to Evaluate the Efficacy and Safety of SHR6390 Combined With Pyrotinib in HER2+ Advanced Breast Cancer

DAP-Her-01
Start date: April 1, 2020
Phase: Phase 2
Study type: Interventional

The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.

NCT ID: NCT04276272 Recruiting - Clinical trials for Metastatic Breast Cancer

D4 Choline Breast PET/CT

Start date: February 24, 2022
Phase:
Study type: Observational

The aim of this study is to evaluate the effect of CDK4/6 inhibitor treatment on the tumour choline metabolism as determined by [18F]D4-FCH PET/ computed tomography(CT) in breast cancer and to determine the suitability of [18F]D4-FCH-PET/CT as a non-invasive, early imaging biomarker for therapy response following CDK4/6 inhibitor treatment.

NCT ID: NCT04265274 Withdrawn - Clinical trials for Metastatic Breast Cancer

Vinorelbine, Cisplatin, Disulfiram and Copper in CTC_EMT Positive Refractory Metastatic Breast Cancer.

Start date: January 1, 2020
Phase: Phase 2
Study type: Interventional

This is a proof-of-concept study to define efficacy of vinorelbine, cisplatin, disulfiram and copper in CTC_EMT positive refractory metastatic hormone receptor positive, HER2 negative breast cancer.

NCT ID: NCT04263298 Recruiting - Clinical trials for Metastatic Breast Cancer

Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer

Start date: May 1, 2018
Phase: Phase 3
Study type: Interventional

This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer.

NCT ID: NCT04262518 Recruiting - Breast Cancer Clinical Trials

Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients

FIONA
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

This study aims to investigate the role of a mobile health app, Outcomes4Me, in the navigation of care for people with breast cancer.

NCT ID: NCT04258735 Recruiting - Clinical trials for Metastatic Breast Cancer

Genetic Characteristics of Metastatic Breast Cancer Patients

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

Genomic analysis for metastatic breast cancer(MBC) patients - Participant (Inclusion criteria) 1. Patients who diagnosed metastatic/stage IV breast cancer 2. Patients who were not received treatment for metastatic breast cancer on palliative setting - Process (1) Tissue/ Blood sample - At diagnosis, MBC tissue / blood sample (20cc) will be obtained. - At disease progression after 1st line treatment for MBC, blood sample (20cc) will be obtained (tissue; optional) (2) WES, RNASeq, ctDNA, Exosome - We will analyze genomic characteritics using WES, RNASeq, ctDNA, Exosome.

NCT ID: NCT04258163 Completed - Clinical trials for Metastatic Breast Cancer

Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy

Start date: January 1, 2019
Phase:
Study type: Observational

To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic breast cancer (MBC).

NCT ID: NCT04253561 Recruiting - Clinical trials for Metastatic Breast Cancer

Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients

IPATHER
Start date: February 25, 2020
Phase: Phase 1
Study type: Interventional

This is an open label, single arm, multicenter, phase Ib study to evaluate the safety and clinical activity of the combination of ipatasertib, trastuzumab and pertuzumab in patients with unresectable locally advanced or metastatic HER2-positive breast cancer with tumors harboring PIK3CA mutations, candidates to receive maintenance HP after first line treatment for metastatic disease with a taxane plus HP

NCT ID: NCT04252768 Withdrawn - Clinical trials for Metastatic Breast Cancer

A Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients to Test a New Schedule of Efti (IMP321, Eftilagimod Alpha) as Adjunctive to a Weekly Treatment Regimen of Paclitaxel

AIPAC-002
Start date: June 2023
Phase: Phase 1
Study type: Interventional

This is a multicentre, multinational Phase Ib study in female HR+ MBC patients not receiving Her2-targeted therapy. Treatment consists of a chemo-immunotherapy phase followed by a maintenance phase. The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 80 mg/m2 paclitaxel intravenously on Day 1, 8 and 15 and 30 mg efti subcutaneously on Day 1 and 15 in a 28-day (4-week) cycle. Efti will always be given after paclitaxel. The maintenance phase comprises 6 visits with 4 weekly intervals; during each such visit 30 mg efti is given subcutaneously as monotherapy. A total of 24 subjects will be enrolled into the study. The primary goal of the study is safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day in contrast to subsequent days as in the AIPAC trial.