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Breast Neoplasms clinical trials

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NCT ID: NCT02603679 Active, not recruiting - Clinical trials for Estrogen Receptor Positive Tumor

Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases

PREDIX LumB
Start date: February 2015
Phase: Phase 2
Study type: Interventional

The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of chemotherapy using weekly paclitaxel (arm A) versus the combination of the cdk 4/6 inhibitor palbociclib and standard endocrine treatment (arm B). After 12 weeks treatment is switched crossover. During the 24-weekly treatment period, clinical and radiological evaluations are performed repeatedly. Switch between the treatment arms A and B is allowed in case of lack of response or due to toxicity. A translational subprotocol is a mandatory part of the study protocol, except for use of PET-CT evaluations. Postoperatively, patients receive three 3-weekly courses of chemotherapy with a combination of epirubicin and cyclophosphamide.

NCT ID: NCT02603341 Active, not recruiting - Breast Cancer Clinical Trials

Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

Start date: February 2016
Phase: N/A
Study type: Interventional

A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of December, 2024, www.radcomp.org.

NCT ID: NCT02595905 Active, not recruiting - Clinical trials for Recurrent Breast Carcinoma

Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases

Start date: September 15, 2016
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer that has come back (recurrent) or has or has not spread to the brain (brain metastases). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. It is not yet known if cisplatin is more effective with or without veliparib in treating patients with triple-negative and/or BRCA mutation-associated breast cancer.

NCT ID: NCT02595762 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

A Study of Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

Start date: October 30, 2016
Phase:
Study type: Observational

This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).

NCT ID: NCT02595320 Active, not recruiting - Breast Cancer Clinical Trials

Capecitabine in Metastatic Breast and GI Cancers

X7-7
Start date: October 5, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is compare different doses of capecitabine to see if one is better than the other in terms of efficacy and toxicity.

NCT ID: NCT02595138 Active, not recruiting - Clinical trials for Triple Negative Breast Cancer

Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer

Start date: October 2015
Phase: Phase 3
Study type: Interventional

Triple-negative breast cancer is a special type of breast cancer with poor prgnosis and limited choices. Chemotherapy is the only choice of adjuvant systemic treatment options. Previous study suggested that zoledronic acid might have anti-tumor effect by eliminating the number of DTCs(Disseminated Tumor Cell )and had been proved to be effective as adjvant therapy in postmenopausal women whose breast cancer was Homonal receptor positive and who were receiving aromatase inhibitors. So it might be able to improve the survival of triple negative breast cancer patients.

NCT ID: NCT02593175 Active, not recruiting - Clinical trials for Triple-Negative Breast Carcinoma

Women's MoonShot: Neoadjuvant Treatment With PaCT for Patients With Locally Advanced TNBC

Start date: August 26, 2016
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well panitumumab, carboplatin and paclitaxel work in treating patients with newly diagnosed triple negative breast cancer that is limited to the breast and possibly to the nearby lymph nodes (locally advanced). This treatment study is linked to NCI-2015-00191 protocol, which uses a baseline biopsy to determine the neoadjuvant therapy that matches the sub-type of triple negative breast cancer (TNBC). Immunotherapy with panitumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab, carboplatin and paclitaxel before surgery may be an effective treatment for breast cancer by making the tumor smaller and reducing the amount of normal tissue that needs to be removed.

NCT ID: NCT02592746 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

A Study of Palbociclib With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With HR+ MBC

Start date: June 2016
Phase: Phase 2
Study type: Interventional

Despite recent advances for the treatment of post-menopausal hormone receptor-positive BC, in the last decade there was no major improvement of hormonal therapy specifically for premenopausal metastatic breast cancer. The median age of breast cancer is much younger, and the proportion of young breast cancer (YBC) patients (less than 40) including premenopausal women is much higher, in Asia, including Korea. Capecitabine, the comparator in this trial, is an orally-administered fluoropyrimidine derivative and has shown high efficacy and low toxicity in metastatic breast cancer patients. Palbociclib is a CDK4/6 inhibitors, in combination with endocrine therapy showed marked advance in hormone receptor-positive MBC in the post-menopausal setting. After a median follow-up of 16.5 months, preliminary results from Part 1 of this Phase 2 trial suggest that the combination of PD-0332991 with letrozole is superior to letrozole alone, and improved objective response and disease control rates (52% vs 32% and 76% vs 47%, respectively) in patients treated with the combination. These remarkable results may contribute to have much benefit with endocrine therapy for premenopausal women. Most importantly, recent PALOMA-3 trial revealed superior results of adding palbociclib to fulvestrant (median PFS 9.2 vs 3.8 months, P<0.001). Based on these rational backgrounds, the purpose of this phase II study is to assess the safety and the clinical anti-tumor activity of exemestane plus goserelin acetate in combination with palbociclib vs capecitabine in premenopausal hormone receptor-positive advanced breast cancer patients

NCT ID: NCT02592083 Active, not recruiting - Clinical trials for Hormone Receptor Positive Tumor

Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors

PREDIX LumA
Start date: October 2015
Phase: Phase 2
Study type: Interventional

The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6 inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive endocrine treatment for 4 weeks. In case of decrease of proliferation (Ki67) patients are then randomized between either continuous endocrine therapy (arm A) or the same treatment with addition of palbociclib (arm B). Patients with no change of proliferation are allocated to endocrine treatment + palbociclib without randomization (arm C). During the 12-weekly treatment period, clinical and radiological evaluations are performed repeatedly. Switch between the treatment arms A and B is allowed in case of lack of response or due to toxicity. A translational subprotocol is a mandatory part of the study protocol, except for use of PET-CT evaluations.

NCT ID: NCT02581670 Active, not recruiting - Breast Cancer Clinical Trials

Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer

Start date: November 4, 2015
Phase: N/A
Study type: Interventional

Investigators designed a phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach.