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HER2-negative Breast Cancer clinical trials

View clinical trials related to HER2-negative Breast Cancer.

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NCT ID: NCT05503108 Suspended - Clinical trials for HER2-negative Breast Cancer

Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer

DIRECT-2
Start date: March 17, 2023
Phase: Phase 3
Study type: Interventional

In preclinical research, short-term fasting (STF) protects tumor-bearing mice against the toxic effects of chemotherapy, improves the CD8+ effector T-cell intratumor infiltration, while enhancing the chemotherapy efficacy. Short-term use of a "fasting-mimicking diet" (FMD) caused a major increase in the efficacy of cancer treatment in mice comparable to STF. In humans, the investigators recently performed a multicenter randomized phase II trial showing that patients with Human Epidermal growth factor Receptor 2 (HER2) negative breast cancer treated with neoadjuvant chemotherapy and FMD displayed a better radiological response and a better pathological response (90-100% vs <90% tumor cell reduction) than patients treated with chemotherapy without FMD (de Groot, Nat Commun 2020; NCT02126449). Therefore these findings will be validated in a phase 3 trial with the underlying hypothesis that FMD during neoadjuvant chemotherapy for breast cancer improves clinical outcomes, potentially due to improved local immunity.

NCT ID: NCT05467891 Recruiting - Clinical trials for HER2-negative Breast Cancer

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

RaPhLRR
Start date: September 13, 2022
Phase: Phase 2
Study type: Interventional

This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.

NCT ID: NCT05452213 Recruiting - Breast Cancer Clinical Trials

Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

CAPTOR-BC
Start date: October 12, 2022
Phase: Phase 4
Study type: Interventional

This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.

NCT ID: NCT05396612 Recruiting - Breast Cancer Clinical Trials

Role of the Immune Environment in Response to Therapy in Breast Cancer

Start date: October 3, 2022
Phase:
Study type: Observational

This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers. No randomization or changes to standard of care treatment will occur as part of the study.

NCT ID: NCT05383196 Recruiting - Breast Cancer Clinical Trials

Onvansertib + Paclitaxel In TNBC

Start date: September 30, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This research is being done to evaluate the safety and effectiveness of Onvansertib in combination with Paclitaxel in triple-negative breast cancer (TNBC) that has spread to other parts of the body. The names of the study interventions involved in this study are: - Onvansertib - Paclitaxel

NCT ID: NCT05340413 Recruiting - Clinical trials for Metastatic Breast Cancer

Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer.

RADIOLA
Start date: March 25, 2022
Phase: Phase 2
Study type: Interventional

The primary objetive is to assess the capacity of the RAD51-foci score to predict the efficacy of olaparib in BRCA1/2, PALB2 or RAD51C/D mut advanced breast cancer (cohort 1). The investigators propose the hypothesis that the RAD51-foci low tumours determined by immunofluorescence using RAD51 assay in patients with BRCA1/2, PALB2 & RAD51C/D mutation (cohort 1) predicts response to olaparib. Furthermore, The investigators posit that the determination of RAD51-foci score in tumour identifies patients who can benefit from olaparib beyond mutations in these 5 genes. This hypothesis will be tested in cohort 2.

NCT ID: NCT05334147 Not yet recruiting - Clinical trials for HER2-negative Breast Cancer

Anlotinib Combined With Chemotherapy for the Treatment of HER2 Negative Advanced Breast Cancer

ALOT-BC1
Start date: April 15, 2022
Phase:
Study type: Observational

The study is being conducted to evaluate the efficacy and safety of anlotinib combined with chemotherapy treatment for patients with HER2 negative advanced breast cancer previously received anthracyclines and taxanes

NCT ID: NCT05333328 Recruiting - Breast Cancer Clinical Trials

OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

INTERSTELLAR
Start date: February 6, 2023
Phase: Phase 4
Study type: Interventional

Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®). In these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.

NCT ID: NCT05305924 Recruiting - Clinical trials for HER2-negative Breast Cancer

Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer

Start date: February 25, 2021
Phase: Phase 2
Study type: Interventional

The study will investigate if CDK4/6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage such patients.

NCT ID: NCT05275777 Active, not recruiting - Clinical trials for Advanced Solid Tumor

A Phase Ib Safety lead-in, Followed by Phase II Trial of ADG106 in Combination With Neoadjuvant Chemotherapy in HER2 Negative Breast Cancer

Start date: May 19, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label, lead in phase Ib dose confirmation study in patients with advanced solid tumors, followed by a phase II single arm study as neoadjuvant therapy in stage I-III HER2 negative breast cancer. Primary Objectives - To determine the safety profile of combination of ADG106 with dose dense doxorubicin/cyclophosphamide, and with weekly paclitaxel. - To determine the Recommended Phase 2 Dose (RP2D) of ADG106 in combination with dose dense doxorubicin/cyclophosphamide, and with weekly paclitaxel. - To evaluate biological changes on immunohistochemistry in HER2 negative breast cancer after treatment with ADG106 alone and in combination with chemotherapy. Secondary Objectives - To determine the efficacy of combination of ADG106 with standard neoadjuvant combination chemotherapy in HER2 negative breast cancer: objective response rates. - To correlate tumor and plasma biomarkers with efficacy outcomes.