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Breast Neoplasms clinical trials

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NCT ID: NCT04320979 Recruiting - Breast Cancer Clinical Trials

Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients

Start date: May 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients treated with mastectomy.

NCT ID: NCT04320693 Approved for marketing - Clinical trials for Metastatic Triple-Negative Breast Carcinoma

Expanded Access for IMMU-132

Start date: n/a
Phase:
Study type: Expanded Access

This is an expanded access program (EAP) for eligible participants designed to provide access to IMMU-132.

NCT ID: NCT04320030 Completed - Clinical trials for Triple Negative Breast Cancer

[18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) in Triple Negative Breast Cancers

EITHICS
Start date: June 11, 2020
Phase: Phase 2
Study type: Interventional

This phase II study is assessing the correlation between M1/M2 macrophage polarization determined by tumor immunohistochemistry analysis and [18F]DPA-714 PET/CT binding (qualitative and texture analysis) in patients with operable triple negative breast cancer.

NCT ID: NCT04319510 Recruiting - Breast Cancer Clinical Trials

Supportive Effects of Craniosacral Therapy for Female Patients With Breast Cancer and Their Partners

CRANIO4US
Start date: September 18, 2023
Phase: N/A
Study type: Interventional

Craniosacral Therapy (CST) is a non-manipulative, very gentle, manual treatment method that aims to release restrictions of the fasciae and regulate the arousal of the sympathetic nervous system, which is often increased in chronically ill patients. Initial randomized trials support CST's efficacy and effectiveness in reducing symptoms of patients with psychosomatic and chronic pain disorders. To date, there is no trial investigating the effectiveness of CST as a supportive strategy for enhancing cancer-related quality of life in women with breast cancer. In clinical practice, therapists also report alleviating as well as regulating effects of simple CST self-help techniques, offered to patients within a group concept. Within the recent study, a CST treatment and self-help protocol for women after curative therapy of breast cancer was developed and shall be tested against a waiting list control group. The first group will receive 24 units of CST treatment in a 1:1 setting with a certified craniosacral therapist over 12 weeks. The second group will receive 24 units of group training in CST self-help techniques offered by a certified craniosacral therapist over 12 weeks. They will be reassessed after 12 and 26 weeks (6 months) after randomization. The third group will wait for 26 weeks and will receive no specific study intervention. After 26 weeks patients of the third group were offered to take part in two individual CST interventions and the CST self-help training. For all groups, treatment as usual is allowed.

NCT ID: NCT04318223 Recruiting - Clinical trials for Metastatic Breast Cancer

Palbociclib Plus Fulvestrant in Women With Hormone Receptor Positive and Human Epidermal Growth Factor Receptor Type 2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination With Hormonal Therapy

Start date: July 16, 2019
Phase: Phase 2
Study type: Interventional

The aim of the present study is to evaluate the efficacy and safety of palbociclib plus fulvestrant after failure of a combined treatment of hormonal therapy (aromatase inhibitor or tamoxifen ± LHRHa) plus a CDK4/6 inhibitor, in women with HR+ and HER2- LABC or MBC. Primary endpoint: 1. To assess the clinical benefit rate (CBR) of the combination treatment palbociclib plus fulvestrant at progression of a combined treatment of hormonal therapy (aromatase inhibitor or tamoxifen ± LHRHa) and a CDK4/6 inhibitor. Clinical benefit rate for primary efficacy endpoints derivation will be based on the local (treating center's) radiologist's/investigator's tumor assessment. - For patients with measurable disease at baseline, progression will be determined according to the RECIST criteria v1.1. - In the absence of measurable disease at baseline, patients with bone only lesions, lytic or mixed (lytic + sclerotic), will be allowed to enter the study and the following will be considered disease progression among these patients: - The appearance of one or more new lytic lesions in bone, - The appearance of one or more new lesions outside of bone, - Unequivocal progression of existing bone lesions. Note: Pathologic fracture, new compression fracture, or complications of bone metastases will not be considered as evidence of disease progression, unless one of the above-mentioned criteria is fulfilled. 2. To assess the Quality of Life (QoL) of patients receiving the combination treatment palbociclib plus fulvestrant at progression of a combined treatment of hormonal therapy (aromatase inhibitor or tamoxifen ± LHRHa) and a CDK4/6 inhibitor. Secondary Endpoints: 1. To evaluate the efficacy of the combination of fulvestrant plus palbociclib at the progression of a combined treatment of hormonal therapy (aromatase inhibitor or tamoxifen ± LHRHa) and CDK4/6 inhibitors with respect to: - Overall response rate (ORR) - Progression Free Survival (PFS) - Overall Survival (OS) - Safety and tolerability 2. To assess predictive biomarkers of response/resistance to fulvestrant plus palbociclib using metastatic tumor tissue samples and liquid biopsies. This study will be performed in pre- and post-menopausal women with HR+/HER2- LABC or MBC whose disease is progressing to a CDK4/6 inhibitor in combination with hormonal therapy (aromatase inhibitor or tamoxifen ± LHRHa). Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first.

NCT ID: NCT04316247 Not yet recruiting - Breast Carcinoma Clinical Trials

Demographic , Clinicopathological Characteristics and Survival of Breast Cancer

Start date: April 1, 2021
Phase:
Study type: Observational

The investigators will retrospectively study the demographic , clinicopathological characteristics and survival of breast cancer patients admitted to Assiut University hospital from the year 2015 to 2019

NCT ID: NCT04316169 Withdrawn - Solid Tumor Clinical Trials

Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer

Start date: October 21, 2021
Phase: Phase 1
Study type: Interventional

The hypothesis is that abemaciclib synergizes with autophagy inhibitor hydroxychloroquine (HCQ/ Plaquenil), inducing apoptosis leading to tumor regression.

NCT ID: NCT04316156 Completed - Breast Cancer Clinical Trials

Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; Randomized Controlled Trial

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

This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in post-operative patients with breast cancer. This is prospective study. 100 breast cancer patients who underwent axillary lymph node diessection or breast reconstruction following mastectomy will be examined, and those with limited range of motion (ROM) of affected shoulder will be enrolled in the study. Shoulder ROM, Quick-DASH, pain evaluation with NRS, quality of life evaluation with FACT-B and EQ-5D will be evaluated on enrollment, 4-week, 8-week, and 12-weeks after enrollment.

NCT ID: NCT04316117 Active, not recruiting - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study

Start date: September 15, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well FDG-PET/CT works in assessing the response of patients with breast cancer that has spread to the bones or mostly to the bones (bone-dominant metastatic breast cancer). Diagnostic procedures, such as FDG-PET/CT, may work better in measuring breast cancer activity before and after treatment compared to other standard imaging tests.

NCT ID: NCT04315233 Recruiting - Clinical trials for Metastatic Breast Cancer

Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics

CHARGE
Start date: May 3, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label, multi-center, phase I study designed to assess the maximum tolerated dose of ribociclib and belinostat in combination. The trial will open with a dose escalation followed by an expansion cohort at the identified dose. Dose escalation will be open to the enrollment of patients diagnosed with triple-negative breast cancer or ovarian cancer. Dose expansion will only be open to patients diagnosed with triple-negative breast cancer.