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Breast Cancer clinical trials

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NCT ID: NCT05768139 Recruiting - Breast Cancer Clinical Trials

First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Start date: April 17, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Study STX-478-101 is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 in participants with advanced solid tumors with certain mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors and breast cancer; Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.

NCT ID: NCT05767424 Recruiting - Breast Cancer Clinical Trials

Prospective Observational Study for Breast Microcalcifications' Classification With Artificial Intelligence Techniques

Start date: July 22, 2022
Phase:
Study type: Observational

Breast microcalcifications are a common mammographic finding. Microcalcifications are considered suspicious signs of breast cancer and a breast biopsy is required, however, cancer is diagnosed in only a few patients. Reducing unnecessary biopsies and rapid characterization of breast microcalcifications are unmet clinical needs. This study intends to implement a classification method for breast microcalcifications (as begnin or malign) with Artificial Intelligence techniques on mammographic images, evaluating the diagnostic performance (accuracy) of this approach. Another aim is the development of a diagnostic tool able to determining in-situ the biomolecular characteristics of microcalcifications. Raman spectroscopy (RS) is a highly specific method from the biomolecular point of view and it is able to explore molecular composition of a given sample through its direct irradiation (through laser light) and the simultaneous acquisition of emission signals. RS information could be combined togheter with imaging features to implement an AI model for the combined classification of breast microcalcifications

NCT ID: NCT05766891 Recruiting - Breast Cancer Clinical Trials

Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery

Start date: October 12, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.

NCT ID: NCT05766410 Recruiting - Breast Cancer Clinical Trials

A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC

ORACLE-RIPA
Start date: September 16, 2022
Phase: Phase 2
Study type: Interventional

The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all provided progression-free survival benefits when combined with endocrine therapy in advanced ER+/HER2- breast cancer. But, not all of them provided overall survival benefit in the same setting. One of the proposed mechanisms that influence the overall survival difference is from the different influence of the 3 CDK4, 6 inhibitors on tumor microenvironment and/ or immune system. However, there was no head-to-head comparison of the 3 CDK4, 6 inhibitors in the same study. Neoadjuvant therapy provides a window to obtain tissue samples before treatment, during treatment, and after treatment. We aim to compare the immune modulation effects of palbociclib, ribociclib, and abemaciclib with letrozole in neoadjuvant treatment for ER+/HER2- early breast cancer.

NCT ID: NCT05765916 Recruiting - Breast Cancer Clinical Trials

An Online Psychosocial Intervention for Fear of Cancer Recurrence in Breast Cancer Survivors

Start date: September 30, 2022
Phase: N/A
Study type: Interventional

A total of 244 breast cancer survivors will be invited to participate in the randomized controlled trial. Breast cancer survivors who meet the inclusion criteria and provide digital informed consent will be included. Participants will be stratified and randomized by the severity of baseline fear of cancer recurrence and time since diagnosis. In the control arm, women will be treated as usual. In the intervention arm, women will be offered a six-weekly, 60 min, online mindfulness and acceptance intervention. An online questionnaire will be used to collect data at four time points: before the first group session, immediately after the intervention, three months, and six months post-intervention. Phone interviews exploring participants' experiences will be held immediately after the intervention with women of the intervention group.

NCT ID: NCT05765851 Recruiting - Breast Cancer Clinical Trials

A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors

Start date: May 30, 2023
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety and efficacy of DS-1103a combination therapy in patients with advanced solid tumors.

NCT ID: NCT05763992 Recruiting - Breast Cancer Clinical Trials

Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemoimmunotherapy and a FASTing-like Approach in the Preoperative Setting: the BREAKFAST 2 Trial

BREAKFAST-2
Start date: May 15, 2023
Phase: Phase 2
Study type: Interventional

Italian, multicenter, open-label, two-arm, comparative, randomized phase II study investigating if the addition of the experimental metabolic intervention consisting in cycles of Fasting-Like Approach, as administered every three weeks up to a maximum of 8 consecutive cycles, is able to increase the anticancer activity of standard preoperative chemo-immunotherapy in patients with localized invasive Triple Negative Breast Cancer.

NCT ID: NCT05763641 Recruiting - Breast Cancer Clinical Trials

TAD After Chemotherapy in Locally Advanced Breast Cancer

Start date: February 1, 2021
Phase:
Study type: Observational [Patient Registry]

This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and/or cT4).

NCT ID: NCT05762900 Recruiting - Breast Cancer Clinical Trials

Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients

UNIQUE
Start date: October 25, 2022
Phase: Phase 2
Study type: Interventional

This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.

NCT ID: NCT05762042 Completed - Breast Cancer Clinical Trials

Comparison of the Efficacy and Tolerability of Femal Versus Placebo

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

Femal, a food supplement based on pollen extracts introduced in Europe in 1999, is a non-estrogenic alternative to hormone replacement therapy in women with vasomotor symptoms. Patients with prior breast cancer, spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by GNRH analogue and experiencing severe vasomotor symptoms (at least 20 hot flashes per week) will be included. Patients who are on tamoxifen or anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry. Patients on SSRI or SNRI antidepressant therapy are excluded. Eligible patients will be randomly assigned to either Femal (2 cp/day) or placebo (2 cp/day) for 3 months (double-blind study).