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Breast Neoplasms clinical trials

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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: NCT05764941 Recruiting - Breast Neoplasms Clinical Trials

Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for HER2-positive Metastatic Breast Cancer

Start date: January 1, 2020
Phase:
Study type: Observational

This is a real world study to evaluate the efficacy and safety of inetetamb combined with pyrotinib and vinorelbine as first-line to third-line treatment after trastuzumab progression in HER2-positive metastatic breast cancer.

NCT ID: NCT05764577 Completed - Breast Neoplasms Clinical Trials

DIEP Flap Surgery and Intraabdominal Pressure

Start date: April 19, 2021
Phase:
Study type: Observational

Aim: The primary aim of this study is to test if closure of the abdominal donor site increases the Intraabdominal Pressure (IAP) in women undergoing secondary Deep Inferior epigastric perforator (DIEP) flap breast reconstruction. Materials and method: By an Unometer, attached to a standard catheter in the bladder, we measured the intravesical pressure as a surrogate marker for the IAP, at baseline, immediate after- and 24 hours after abdominal skin closure, for 13 patients.

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: NCT05763472 Recruiting - Clinical trials for BRCA-Associated Breast Carcinoma

Breast Cancer After Ovarian Cancer During and/or After Therapy: Genomic Evaluation

Gen-eva
Start date: March 1, 2022
Phase:
Study type: Observational

This study will investigate, in patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer, the presence of molecular alterations potentially involved in the mechanisms of resistance to antineoplastic treatment on breast and ovarian tumor tissue.

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).

NCT ID: NCT05761470 Recruiting - Clinical trials for Her-2 Negative Breast Cancer

Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation

IMPARP
Start date: May 6, 2022
Phase: Phase 2
Study type: Interventional

This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.