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Breast Neoplasms clinical trials

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NCT ID: NCT06156397 Not yet recruiting - Breast Cancer Clinical Trials

The Effect of Technological Based Rehabilitation Practices After Breast Cancer Surgery

Start date: November 30, 2023
Phase: N/A
Study type: Interventional

The aim is to investigate the effects of supervised exercise program, telerehabilitation program and mobile application supported exercise program, applied in the acute period after breast cancer surgery, on upper extremity dysfunction.

NCT ID: NCT06154590 Not yet recruiting - Chronic Pain Clinical Trials

Anastrozole Adjuvant Trial - Study of Anastrozole Compared to NOLVADEX (Tamoxifen Citrate) for Adjuvant Treatment of Early Breast Cancer Clinical Studies), Adjunct Cytotoxic Chemotherapy and Malignant Joint Tumor

NASBP-B-09
Start date: July 2024
Phase:
Study type: Observational [Patient Registry]

At a median follow-up of 33 months, the combination of anastrozole and NOLVADEX (tamoxifen citrate) did not demonstrate any efficacy benefit when compared to NOLVADEX (tamoxifen citrate) therapy given alone in all patients as well as in the hormone receptor positive subpopulation. This treatment arm was discontinued from the trial. This study is now a combination therapy whereas the median duration of adjuvant treatment for safety evaluation is 59.8 months and 59.6 months for patients receiving anastrozole 1 mg and NOLVADEX (tamoxifen citrate) 20 mg, respectively.

NCT ID: NCT06154109 Not yet recruiting - Clinical trials for Triple Negative Breast Neoplasms

Comparative Efficacy of Xiaopi Granules and Decoction in Triple-negative Breast Cancer: a Randomized Controlled Trial

Start date: November 25, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare the efficacy of xiaopi granules and decoction in improving the pathological complete response (pCR) of neoadjuvant chemotherapy of triple-negative breast cancer. The main objective aims to answer whether Xiaopi granules combined with neoadjuvant Chemotherapy could improve the pCR rate of triple-negative breast cancer. The secondary outcome included genomics of plasma extracellular vesicles, plasma metabolites and metabolomics, urine metabolomics, fecal intestinal flora tests, pathological tissue genomics, functional assessment of cancer therapy breast (FACT-B), and adverse events. Participants enrolled in this study will be randomized to xiaopi granules plus neoadjuvant chemotherapy, or xiaopi decoction plus neoadjuvant chemotherapy, or placebo plus neoadjuvant chemotherapy alone. Researchers will compare the pathological complete response between xiaopi granules and decoction group, and to determine their effects in chemosensitizing triple-negative breast cancer.

NCT ID: NCT06151249 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

Evaluate the Meritup Oral Solution to Decrease Fatigue in Metastatic Breast Cancer Patients Receiving Chemotherapy

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

A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety profile and ability of Meritup oral solution to decrease fatigue in metastatic breast cancer patients receiving chemotherapy.

NCT ID: NCT06150898 Not yet recruiting - Clinical trials for Early-stage Breast Cancer

Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)

KePreSt
Start date: February 20, 2024
Phase: Phase 2
Study type: Interventional

Out of all proportion to its short duration, the perioperative period is critical in determining the long-term outcome of cancer. To contribute to a better understanding of the neural and inflammatory mechanisms underlying this issue, we aim to implement a novel intervention based on the preoperative use of non-steroidal anti-inflammatory drugs (NSAIDs) with or without an anti-epileptic drug. Our goal is to understand and transform the perioperative window from being a facilitator of metastatic progression to arresting and/or eliminating residual disease using repurposing drugs

NCT ID: NCT06148038 Not yet recruiting - Breast Cancer Clinical Trials

CBD for Breast Cancer Primary Tumors

Start date: May 31, 2024
Phase: Phase 1
Study type: Interventional

This is a randomized placebo controlled double blind window of opportunity trial. A maximum of 120 patients will be enrolled. Up to 60 patients with invasive breast cancer will be enrolled into cohort 1, and up to 60 patients with DCIS will be enrolled into cohort 2. Patients in each cohort will be randomized 1:1 to either CBD or placebo control using permuted block randomization with random block sizes of 2 or 4. The time window between CBD or placebo initiation and surgery will be between 5 days and 56 days.

NCT ID: NCT06140576 Not yet recruiting - Breast Neoplasms Clinical Trials

The Efficacy and Safety of Lenvatinib Combined With Sindilimab and Nab-paclitaxel in the First-line Treatment for Recurrent and Metastatic Triple Negative Breast Cancer: a Phase Ib/IIa Clinical Trial.

Start date: November 30, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The treatment regimen of lenvatinib combined with PD1 antibody has brought earth shaking changes to the immunotherapy of various "cold tumors". This is a phase Ib/IIa clinical trial to investigate the efficacy and safety of Lenvatinib combined with Sindilimab and Nab-paclitaxel in the first-line treatment for recurrent and metastatic triple negative breast cancer.

NCT ID: NCT06134375 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

A Study of Tetrathiomolybdate (TM) Plus Capecitabine

Start date: July 2024
Phase: Phase 1/Phase 2
Study type: Interventional

There are two parts to this study. It is a phase 1b followed by a randomized phase 2 study to assess whether adding 3 years of adjuvant tetrathiomolybdate (TM) to standard 6 months treatment of adjuvant capecitabine and pembrolizumab in high risk for relapse triple negative breast cancer. In the phase 1b part of the study, TM is added to adjuvant capecitabine and pembrolizumab in high risk for relapse triple negative breast cancer (RCB 2, 3, risk for relapse >60% at 5 years) after completion of neoadjuvant chemo-immunotherapy and surgery to establish the safety of the combination. This will be followed by a randomized phase 2 clinical trial of adjuvant TM and capecitabine vs capecitabine alone. If pembrolizumab was administered in the neoadjuvant setting, it may be continued in the adjuvant setting per investigator discretion.

NCT ID: NCT06133959 Not yet recruiting - Breast Cancer Clinical Trials

Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women With Breast Cancer

HealthyME
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The goal of this two-phase project is to adapt The-Optimal-Lymph-Flow (TOLF) behavioral intervention to be culturally appropriate, and subsequently test the intervention in Black and Hispanic patients. The investigators have developed and tested behavioral intervention program TOLF that builds patients' self-management skills to promote lymph flow and results in complete pain reduction, reduced lymph fluid level, reversed mild lymphedema, and improved quality of life (QOL). Of concern, this promising intervention has not been adapted to reduce patient barriers (e.g., relevance, cost, time, travel, competing demands) and system barriers (e.g., intervention availability, staffing, therapist) to timely interventions faced by Black and Hispanic women. Specific aims are to: Aim 1: Engage Black and Hispanic women (N=24) in adapting TOLF to be highly culturally appropriate. The investigators will conduct focus groups to refine TOLF focusing on barriers faced by and preferences of Black and Hispanic women. Aim 2: Conduct a pilot randomized controlled trial (RCT) (N=60) equally allocating women to either 1) TOLF or 2) lymphedema education (e-Lymph) to examine feasibility, acceptability, and examine primary outcomes (lymphatic pain, pain severity and interference, and lymph fluid level) and secondary outcomes (daily living function, psychological distress, QOL, self-efficacy for pain management) of the culturally appropriate behavioral interventions.

NCT ID: NCT06131632 Not yet recruiting - Clinical trials for Inflammatory Breast Cancer

Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

ConSIBreC
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast. Current treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy. In the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response. There are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. This may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy.