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Breast Neoplasms clinical trials

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NCT ID: NCT04194684 Not yet recruiting - Breast Cancer Clinical Trials

Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer

Start date: December 28, 2019
Phase: Phase 2
Study type: Interventional

This study is a single-arm, open, multi-center clinical study of nab-paclitaxel as the therapy ER+/HER2- recurrent metastatic breast cancer。

NCT ID: NCT04188119 Not yet recruiting - Breast Cancer Clinical Trials

A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer

IMpALA
Start date: December 1, 2023
Phase: Phase 2
Study type: Interventional

This research is being done because the investigators are looking for new and better ways to treat a type of breast cancer called triple negative breast cancer. This type of breast cancer can be more difficult to treat than other types of breast cancer as it does not respond to drugs such as hormonal therapies. One type of treatment that looks promising is immunotherapy using new drugs called immune checkpoint inhibitors. Immune checkpoints help to regulate the immune system and can stop the immune system from attacking cancer cells. Immune checkpoint inhibitors block this 'off-switch' and aim to help the immune system control the cancer. These drugs have been very effective in other cancers such as melanoma and are now being tested in breast cancer. In this study patients will receive an immune checkpoint inhibitor called avelumab. Half the patients on the study will also receive aspirin tablets for approximately 18 days as the investigators wish to compare the effects of avelumab alone versus in combination with aspirin. Patients will attend hospital approximately five times in order to complete all necessary study assessments. The first visit screens patients for suitability, after which a baseline visit will collect the first of two breast tissue biopsies. At the third visit a single dose of Avelumab will be given via an infusion (a drip in the forearm). Patients will then return approximately two weeks later for a second breast tissue biopsy before having a final follow up visit another two weeks later. Blood and urine samples will be taken at various visits throughout the study to help us learn more about the effects these treatments may have on the immune system and on breast cancer cells.

NCT ID: NCT04179318 Not yet recruiting - Breast Cancer Clinical Trials

the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis

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

Geneswell BCT is a precise and qualitative in vitro diagnostic test. The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group. This test provides prognostic information to assess the risk of recurrence. The BCT score calculated by geneswell BCT was associated with the risk of recurrence. The higher the BCT score, the more likely it is to relapse, and vice versa.

NCT ID: NCT04158856 Not yet recruiting - Clinical trials for HER2-positive Breast Cancer

Adjuvant Dual Anti-HER2 Therapy in Patients With Small, Node-negative, HER2-positive Breast Cancer

SHERO
Start date: June 1, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial aims to study the efficacy and safety of adjuvant Pyrotinib plus trastuzumab in patients with tumors <8mm, node-negative, HER2-positive breast cancer.

NCT ID: NCT04158193 Not yet recruiting - Clinical trials for Breast Cancer Lymphedema

Acupuncture for Breast Cancer Related Lymphedema

Start date: November 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the clinical efficacy of acupuncture on chronic upper limb lymphedema in patients with breast cancer surgery

NCT ID: NCT04143906 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer

Start date: October 25, 2019
Phase: Phase 2
Study type: Interventional

Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings. For each randomisation arm, 100 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective. Study Design: Arm A: Vinorelbine 25 mg/m2 d1,8; Carboplatin AUC=6 d1 q 3 weeks; Arm B: Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1 q 3 weeks;

NCT ID: NCT04137640 Not yet recruiting - Breast Cancer Clinical Trials

Palbociclib + Letrozole Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy

Start date: July 19, 2021
Phase: Phase 4
Study type: Interventional

With the development of neoadjuvant therapy for tumors, neoadjuvant chemotherapy (NAC) has become one of the most common and effective methods for preoperative systemic treatment of locally advanced breast cancer (LABC). Although epirubicin combined with cyclophosphamide and sequential docetaxel has been widely recognized as the first-line NAC for LABC, there are still some inoperable LABCs that are insensitive to chemotherapy and miss the opportunity of surgery, especially those with luminal A and low expression of Ki67. Therefore, neoadjuvant endocrine therapy has important clinical value for such patients. At present, the combination of aromatase inhibitor drugs and cyclin dependent kinase 4/6 can significantly improve the prognosis and survival of LABC compared with aromatase inhibitor monotherapy. However, whether inoperable LABC patients, especially those who are not susceptible to chemotherapy, can choose the combination of aromatase inhibitor drugs and cyclin dependent kinase 4/6 as neoadjuvant endocrine therapy to replace NAC remains unclear. Because the main principle of endocrine therapy is to induce tumor cell cycle arrest, leading to apoptosis of tumor cells, the effect is slower than that of chemotherapy. In addition, whether endocrine therapy can replace chemotherapy as a new adjuvant treatment for patients with inoperable LABC to improve the operability rate has not yet been fully evidenced. Therefore, this trial aims to conduct the prospective randomized controlled phase IV clinical trial of palbociclib combined with letrozole versus epirubicin combined with cyclophosphamide and sequential docetaxel as NAC to prove the efficacy of palbociclib combined with letrozole in postmenopausal estrogen receptor-positive LABC patients with low Ki67 expression.

NCT ID: NCT04122131 Not yet recruiting - Breast Cancer Clinical Trials

Fibrotic Focus in Breast Cancer

Start date: December 1, 2019
Phase:
Study type: Observational

Despite the ongoing refinement of current breast cancer staging, clinical outcome is still varied among patients of similar stage. Further exploration of novel prognostic factors is of great clinical value. In our earlier findings, we have demonstrated the added value of fibrotic focus (FF) in the current staging. However the precise composition in different components within FF and underlying mechanism involved remain to be determined. In fact, there is unappreciated heterogeneity in FF. All these have limited its application in clinical practice. In this proposal, a systemic evaluation on the FF features in breast cancers will be performed. We aim to further characterize FF at morphological, cellular and molecular levels as well as its collagen characteristics. Given the multiple lines of evidence showing its relationship with immune components, additional attention will be put on its interaction with immune tumor environment. Finally, we plan to develop prognostic model integrating these different FF features for a more accurate risk stratification. Accumulated evidence suggested that the significance of FF in breast cancer prognosis. Moreover, the impact of fibrotic stroma on tumor immune environment may be implicative in immunotherapy. The more complete understanding of FF is pre-requisite for its development as an applicable prognostic marker in breast cancer.

NCT ID: NCT04116125 Not yet recruiting - Clinical trials for Breast Neoplasm Female

Omitting Biopsy of SEntinel Lymph Node With Radiation After Neoadjuvant Chemotherapy in Breast Cancer (OBSERB) Trial

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

The OBSERB study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with cT1-3N1 and ycN0 breast cancer.

NCT ID: NCT04093609 Not yet recruiting - Breast Cancer Clinical Trials

XIST Gene Deletion in Breast Cancer Therapy

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

Very little is known about the role of X-inactive specific transcript RNA in human breast cancer and in regulating different response to therapy . the relation between the breast cancer predisposing gene BRCA1 & X-inactive specific transcript RNA has been investigated but still controversial. Loss of X chromosome inactivation (XCI) is observed in breast cancer . Other studies sheds light on a possible mechanism of breast carcinogenesis mediated by XIST misbehaviour.