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Advanced Breast Cancer clinical trials

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NCT ID: NCT03669497 Completed - Breast Cancer Clinical Trials

Hypo-Fractionated Radiotherapy in Breast Cancer

HYPORT-B
Start date: January 2, 2018
Phase: N/A
Study type: Interventional

This is a prospective interventional phase I/II study which will be done at Tata Medical Centre, Kolkata. Total 30 eligible female patients, ≥18 years of age, with locally advance invasive carcinoma of breast, not amenable to curative surgery of metastatic breast cancer, planned for palliative loco regional radiotherapy will be enrolled in the study amongst which patients with left sided breast cancer (at least 10) will be recruited to study the feasibility of voluntary breath hold technique for heart sparing. Once consented, all patients will have regional baseline PET-CT scan of breast and tissue biopsy along with blood sampling done before studying radiotherapy. Planning Ct scan will then be taken, with standard planning CT scan for right breast cancers with implementation voluntary breath hold technique for the left breast disease. All patients will be treated with hypo-fractionated radiotherapy with schedule of 26Gy on 5 Fractions over 1 week with 6Gy simultaneously integrated boost with incorporation of breath hold technique for left breast disease. All patients will be assessed weekly during course of radiotherapy. The toxicity will be assessed using CTCAE version 4 and LENT SOMA toxicity criteria and the impact of the hypo-fractionated breast radiotherapy schedule on quality of life in advanced incurable breast cancer patients using FACT B scores PHQ4 questionnaire will also be assessed during treatment and follow-ups tissue bio0psy will be taken after 2 hours of completion of 1 st and last fraction of radiotherapy and biobanked for future radiobiological tests. Response evaluation will be done clinically and by regional PET CT scan using PERSIST criteria in 3 months after completion of radiotherapy. After completion of treatment, patient will initially be followed up every month for 1 st three months thereby 3 monthly for 2 years and 6 monthly for next 3 years.

NCT ID: NCT03481998 Completed - Clinical trials for Advanced Breast Cancer

A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

Start date: March 22, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant. Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for study.

NCT ID: NCT03455270 Completed - Breast Cancer Clinical Trials

G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer

Start date: May 9, 2018
Phase: Phase 1
Study type: Interventional

This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer. The study is an open-label design, consisting of 3 parts: dose-finding portion including food effect (Part 1), G1T48 monotherapy expansion portion (Part 2), and G1T48 in combination with palbociclib expansion portion (Part 3). All parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 184 patients may be enrolled in the study.

NCT ID: NCT03405168 Completed - Clinical trials for Advanced Breast Cancer

Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer

Start date: January 1, 2018
Phase: Phase 2
Study type: Interventional

This is a phase II,single center,prospective, single arm clinical trial. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.

NCT ID: NCT03312738 Completed - Clinical trials for Advanced Breast Cancer

A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor

BOLERO-5
Start date: September 15, 2017
Phase: Phase 2
Study type: Interventional

This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on letrozole or anastrozole.

NCT ID: NCT03285568 Completed - Clinical trials for Metastatic Breast Cancer

Patterns of Prescribing and Monitoring of Palbociclib

Start date: February 3, 2015
Phase:
Study type: Observational

The purpose of this study is to determine if patients with ER+, human epidermal growth factor 2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring based on manufacturer recommendations at a tertiary academic medical center.

NCT ID: NCT03280303 Completed - Clinical trials for Metastatic Breast Cancer

Palbociclib in Real World Practice

Start date: January 4, 2017
Phase:
Study type: Observational

This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.

NCT ID: NCT03240224 Completed - Clinical trials for Advanced Breast Cancer

Bioinformation Therapy for Breast Cancer

Start date: September 2, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable breast cancer.

NCT ID: NCT03205761 Completed - Clinical trials for Advanced Breast Cancer

Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer

COMETABreast
Start date: October 23, 2017
Phase: Phase 2
Study type: Interventional

This is a multicenter single-arm phase II clinical trial to evaluate the efficacy and safety of olaparib in patients diagnosed of advanced triple negative breast cancer (TNBC) with methylation of BRCA1 and/or BRCA2 promoters assessed in DNA from metastatic lesions and absence of BRCA1 and 2 germline mutations.

NCT ID: NCT03072992 Completed - Clinical trials for Metastatic Breast Cancer

"Curcumin" in Combination With Chemotherapy in Advanced Breast Cancer

Start date: March 20, 2017
Phase: Phase 2
Study type: Interventional

The aim of this study is to assess benefits of treatment with intravenous Curcumin® (CUC-01) vs placebo, in combination with paclitaxel chemotherapy, and to estimate the risk of adverse events in patients with locally advanced and metastatic breast cancer. This is a randomized, double-blind, placebo-controlled, two arms parallel group phase 2 clinical trial: Group A, 75 patients, treatment with Curcumin (CUC-01, yellow solution), 300mg i.v. plus i.v. Paclitaxel (colorless solution) 80 mg /m2 BS i.e., once weekly for 12 weeks. Group B, 75 patients, treatment with Paclitaxel (colorless solution) 80 mg /m2 BS, i.v. plus placebo i.v. solution (250 ml, yellow solution for masking/blinding), once weekly for 12 weeks. Primary objective of the study: To assess: - Efficacy of combined therapy with Curcumin ®, (CUC-01) and Paclitaxel vs Paclitaxel in patients with advanced and metastatic breast cancer in terms of Objective Response Rate (ORR) assessed with the Modified Response Evaluation Criteria In Solid Tumours (RECIST). Secondary objectives of the study: To assess: - The safety of Curcumin+Paclitaxel combination compared to Paclitaxel+placebo treatment by assessment of adverse effects. - Quality of life (QOL) in patient treated with Curcumin+Paclitaxel combination compared to Paclitaxel+Placebo - Response duration in terms of Progression free survival (PFS), Time to Disease Progression (TTP) and Time to treatment failure (TTTF)