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Breast Neoplasms clinical trials

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NCT ID: NCT06369285 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

ALISCA-Breast1
Start date: December 31, 2024
Phase: Phase 2
Study type: Interventional

PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.

NCT ID: NCT06364267 Not yet recruiting - Breast Cancer Clinical Trials

Low Dose Tamoxifen vs Low Dose Exemestane in Post-menopausal Women at High Risk for Breast Cancer.

BabyTears
Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine if 6 and 12 months of treatment with Tamoxifen at lower dose is superior to Exemestane at lower dose on quality of life.

NCT ID: NCT06362993 Not yet recruiting - Clinical trials for Breast Cancer Female

Breast Cancer Screening in Ghana

Start date: June 2024
Phase: N/A
Study type: Interventional

This study is designed to test the feasibility of two intervention on promoting early screening for breast cancer in rural Ghana. In one intervention, screening for breast cancer, diabetes and hypertension will be offered together. In another intervention, a series of sessions with men will be conducted with a goal to change gender attitudes and increase support to women. The investigators' long-term goal is to test these interventions in a large-scale randomized controlled trial. The specific aims of this feasibility study are to: 1) refine the study materials, including the curriculum for the sessions with men, by consulting with an expert advisory committee and a local committee, and 2) determine the feasibility of the two interventions in four clinic zones in Yilo-Krobo district in eastern Ghana (1 clinic in control, 1 clinic in the first intervention, and 2 in the second intervention). This trial registration is for the second specific aim.

NCT ID: NCT06362096 Not yet recruiting - Breast Cancer Clinical Trials

A Multicenter, Prospective Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer

Start date: May 2024
Phase: Phase 2
Study type: Interventional

To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib

NCT ID: NCT06361940 Not yet recruiting - Breast Cancer Clinical Trials

Molecular Analyses to Identify Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer

Start date: August 2024
Phase: Phase 2
Study type: Interventional

This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks).

NCT ID: NCT06358625 Not yet recruiting - Clinical trials for HER2-positive Breast Cancer

Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer

CRANIUM
Start date: April 30, 2024
Phase:
Study type: Observational

HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies. In the early 2000s, trastuzumab revolutionised the management of patients with HER2-positive (HER2+) breast cancer in the metastatic and localised stages of the disease. At the time of diagnosis of metastatic disease, 7-11% of patients have brain metastases, with (70% of cases) or without symptoms (30% of cases). In the absence of brain metastases, 30% to 50% of patients will develop brain metastases within the first two years of treatment, depending on whether the disease is hormone receptor positive (HR+) or negative (HR-). The presence of brain metastases is the most important prognostic factor. The neurological symptoms caused by the presence of these lesions, but also by the local treatments offered, affect patients' quality of life, although improvements in surgical and radiotherapy techniques have significantly reduced the need for particularly toxic whole brain radiotherapy. International guidelines do not recommend systematic brain MRI in the absence of neurological symptoms, either in the adjuvant or metastatic stages of this disease. However, there may be a role for more systematic and earlier screening for cerebral recurrence, as single cerebral recurrences without extracranial involvement are common and the new anti-HER2 agents (i.e. tucatinib, an anti-HER2 tyrosine kinase inhibitor, and T-Dxd) have shown significant objective response rates in cerebral metastases. To date, no clinical or histological prognostic factor (proliferation index, HR expression, etc.) has been used to identify a population of patients at high risk of cerebral relapse, allowing monitoring and treatment to be personalised. New tools for these indications would significantly modify our clinical practice, allowing the identification of a subpopulation at high risk of cerebral recurrence, suitable for increased monitoring and therapeutic adjustment.

NCT ID: NCT06358573 Not yet recruiting - Clinical trials for Triple-negative Breast Cancer

Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK

Start date: June 30, 2024
Phase: Phase 2
Study type: Interventional

About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer. Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response (pCR) to treatment. In the phase II study SAKK 66/22, it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes. The tolerability of INT230-6 as well as other factors such as response to treatment and the possibility of breast-conserving surgery are also being examined.

NCT ID: NCT06355037 Not yet recruiting - Clinical trials for Triple-negative Breast Cancer

Dasatinib Combined With Quercetin to Reverse Chemo Resistance in Triple Negative Breast Cancer

Start date: April 10, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of dasatinib, quercetin with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy.

NCT ID: NCT06355024 Not yet recruiting - Clinical trials for Triple-negative Breast Cancer

Inosine Reverse Chemo Resistance in Triple Negative Breast Cancer

Start date: April 10, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of Inosine with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy.

NCT ID: NCT06354114 Not yet recruiting - Clinical trials for Advanced Breast Cancer

A Study to Evaluate the Efficacy and Safety in Subjects With Advanced Breast Cancer Treated With SYHX2011

Start date: April 2024
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety in subjects with advanced breast cancer treated with SYHX2011