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Triple Negative Breast Neoplasms clinical trials

View clinical trials related to Triple Negative Breast Neoplasms.

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NCT ID: NCT04809779 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

PD-1 Inhibitor Concurrent With Chemotherapy as Neoadjuvant Therapy for TNBC

NeoPD1TNBC
Start date: March 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to address the following hypotheses: the PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments. This regimen will induce higher pathologic complete response (pCR) rate in triple negative breast cancer than historical pCR rates (30-40%) observed with chemotherapy alone.

NCT ID: NCT04755868 Not yet recruiting - Clinical trials for TNBC - Triple-Negative Breast Cancer

Talazoparib Maintenance Therapy in Triple-negative Breast Cancer

Start date: March 2021
Phase: Phase 2
Study type: Interventional

The investigators propose a randomized phase II clinical trial of talazoparib maintenance therapy in TNBC patients whose tumor showed clinical benefit (platinum-sensitivity) to first- or second-line platinum-based chemotherapy (monotherapy or combination with other agents). Patients are eligible when they meet at least one of two following platinum-sensitivity criteria: 1. They should have received 6 tri-weekly doses or 18 weekly doses of platinum-based therapy in non-progression status (at least stable disease) at the time of enrollment; 2. They should remain in complete or partial response status after 4-6 tri-weekly doses or 12-18 weekly doses of platinum-based chemotherapy. Eligible patients are enrolled to the trial within 4 to 8 weeks after last chemotherapy and 1:1 randomized to receive talazoparib versus placebo maintenance therapy. The primary endpoint is PFS by RECIST 1.1 after randomization. The secondary endpoints include OS, time from randomization to second progression or death (PFS2), and objective response rate (ORR) by RECIST 1.1, adverse events by CTCAE 5.0 criteria, quality of life evaluated by EORTC-QLQ-C30, and EuroQoL EQ-5D.

NCT ID: NCT04669522 Not yet recruiting - Clinical trials for Triple Negative Breast Neoplasms

Psychological Factors and Oncological Outcomes of Triple-negative Breast Cancer

PSY-ONC TNBC
Start date: December 2020
Phase:
Study type: Observational [Patient Registry]

It has been established that chronic stress can take a toll on one's health. Furthermore, when an someone falls ill, it is believed that the way that they handle stress and/or adversity can positively or negatively impact the course of their disease. Against the background of these findings, this study aims to explore how (1) cumulative lifetime stress exposure, (2) coping response, (3) perceived social support, and (4) and overall psychological well-being may relate to the oncological outcomes of women diagnosed with triple negative breast cancer (TNBC). Patients treated for TNBC between 01.01.2015-31.12.2019 at the University Clinic for Gynecology at Pius-Hospital Oldenburg will be asked to complete four questionnaires corresponding to the abovementioned psychological aspects. The results of these questionnaires will be analyzed together with the clinical patient data and tumor characteristics (such as type, size, etc.) to explore whether there is a tendency between one or more of the above-mentioned psychosocial aspects and the course of the disease (e.g. a disease recurrence within one year after the initial diagnosis (yes / no), the duration of the disease-free or progression-free period). As there is an existing body of evidence supporting a relationship between stress and the immune system, we expect to see the poorest oncological outcomes in patients who 1) have faced more stressful/adverse life events, 2) those who present inadequate/inappropriate coping skills, 3) report less social support, and 4) poorer overall psychological well-being. If a potential connection between psychosocial factors and the course of the TNBC is identified, further disease specific, it will aid in the development of disease-specific, health-promoting measures to better support this particular patient group. This is of great importance, as TNBC is generally associated with clinically aggressive behavior and a worse prognosis compared to other breast cancer subtypes.

NCT ID: NCT04634747 Not yet recruiting - Clinical trials for Metastatic Triple-Negative Breast Carcinoma

Phase 2 Study to Evaluate PVX-410 + Pembrolizumab + Chemotherapy for Metastatic, PD-L1+ Triple-Negative Breast Cancer

Start date: April 30, 2022
Phase: Phase 2
Study type: Interventional

Evaluating the combination of the investigational, multi-peptide cancer vaccine PVX-410 in combination with pembrolizumab and chemotherapy in treatment naive patients with metastatic, triple negative breast cancer who are PDL1 and HLA A2 positive.

NCT ID: NCT04517292 Not yet recruiting - Breast Cancer Clinical Trials

Eribulin Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)

GEP
Start date: October 8, 2020
Phase: Phase 2
Study type: Interventional

Eribulin Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)

NCT ID: NCT04502680 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

Maintenance Treatment With Eribulin Mesylate Versus Observation in Triple Negative Breast Cancer Patients

EMBRAVE-001
Start date: June 2021
Phase: Phase 2
Study type: Interventional

This clinical trial is a multicenter, randomized, open-label, phase-II study to evaluate the efficacy and safety of maintenance treatment with eribulin mesylate following standard adjuvant chemotherapy in triple negative breast cancer patients.

NCT ID: NCT04405505 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)

Start date: June 1, 2020
Phase: Phase 3
Study type: Interventional

This study is a randomized, positive parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus paclitaxel for injection (albumin bound) in subjects with advanced triple negative breast cancer.

NCT ID: NCT04303988 Not yet recruiting - Breast Cancer Clinical Trials

A Multi-cohort Phase II Study of HER2-positive and Triple-negative Breast Cancer Brain Metastases.

Start date: March 30, 2020
Phase: Phase 2
Study type: Interventional

The study is being conducted to assess the effectiveness and safety of treatment options for breast cancer brain metastases based on molecular typing.

NCT ID: NCT04301739 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC)

Start date: April 17, 2020
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-Blind,international multi-Centre, phase III clinical study to evaluate efficacy and safety of HLX10 in combination with chemotherapy versus placebo in combination with chemotherapy as neoadjuvant therapy and HLX10 versus placebo as adjuvant therapy in previously untreated and potentially resectable patients with TNBC and without distant metastasis. Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows: Arm A (HLX10 arm): HLX10 + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → HLX10 + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → HLX10 (9 cycles) Arm B (placebo arm): Placebo + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → Placebo + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → Placebo (9 cycles) The three stratification factors for randomization include: lymph node metastasis (yes or no), size of primary tumor lesion (T1/T2 or T3/T4), asian population (yes or no).

NCT ID: NCT04225858 Not yet recruiting - Breast Cancer Clinical Trials

Avoiding Sentinel Lymph Node Biopsy in Breast Cancer Patients After Neoadjuvant Chemotherapy

ASICS
Start date: January 2020
Phase: N/A
Study type: Interventional

This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy