Breast Cancer Clinical Trial
Open-label, Multi-center, sINGlE Arm Clinical Study to Evaluate Efficacy/QoL in Women With HR+, HER2-, Regionally Recurrent or Metastatic Breast Cancer Receiving Palbociclib With an AI or Fulvestrant After Prior Endocrine Therapy
|Phone||0049- 761- 152420|
|Start date||September 2016|
|Completion date||December 2022|
The purpose of this study is to evaluate the efficacy and quality of life in women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the breast), HR+ / HER2-, who are treated with an aromatase inhibitor or fulvestrant as baseline therapy in combination with palbociclib (Ibrance)
This is a prospective, open-label, multi-center, single arm, non-comparative phase II study
in women with HR+/HER2- advanced breast cancer receiving palbociclib in addition to an
aromatase inhibitor or fulvestrant. The study will take place in Germany (85 study centers).
In total, 360 patients will be enrolled in this study. 6 treatment groups are planned. The study seeks to recruit 60 (58-62) patients per recruitment group. For first-line treatment with palbociclib - and letrozole (Enrollment Group 1), anastrozole (Enrollment Group 2), exemestane (Enrollment Group 3) or fulvestrant (Enrollment Group 4) and 60 (58-62) patients for second- or later-line treatment with palbociclib -and letrozole (Enrollment Group 5) or fulvestrant (Enrollment Group 6). Recruitment will be centrally monitored to allow closure of a respective group as soon as 60 (58-62) patients have been enrolled.
Treatment will be continued until disease progression, intolerable toxicity, death or any other reason. In case a combination partner is discontinued, palbociclib has to be discontinued. In case treatment with palbociclib is stopped, combination partner can be continued according to investigator's discretion. Irrespectively of the combination partner, the discontinuation of palbociclib is defined as end of treatment (EOT) in this study. After EOT the patient enters the follow-up period.
Primary end point is clinical benefit rate 24 weeks after the first study treatment of the patient.
A study independent, decentral, "virtual" biobank will be established. All patients will be asked to give consent for their tumor samples to be used for future investigational research. Study sites will inform the local pathologists about the patient's consent and ask for the tissue sample to be reserved for future analyses. The site is requested to collect contact details of the pathologist storing the tumor sample, the sample's identification number(s), and to document these in the eCRF.
The decision to perform subsequent investigational research studies on collected samples will be based on outcome data from this study or from new scientific findings related to the drug class or disease, as well as reagent and assay availability.
|Completed||NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data||N/A|
|Recruiting||NCT01857193 - Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer||Phase 1|
|Terminated||NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy||N/A|
|Completed||NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis||N/A|
|Active, not recruiting||NCT02371174 - Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.||N/A|
|Completed||NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)||Phase 2/Phase 3|
|Recruiting||NCT01967823 - T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer||Phase 2|
|Recruiting||NCT02739425 - The Efficacy of Sentimag in Detection of Sentinel Node Biopsy||N/A|
|Not yet recruiting||NCT02767661 - Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast Cancer||Phase 3|
|Not yet recruiting||NCT03176888 - Health Benefits of HIT for Breast Cancer Patients||N/A|
|Recruiting||NCT02689427 - Phase IIB Neoadjuvant Enzalutamide (ZT) Plus Taxol for Androgen Receptor (AR)-Positive Triple-Negative Breast Cancer (AR+ TNBC)||Phase 2|
|Recruiting||NCT02980848 - Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study||N/A|
|Recruiting||NCT02903524 - Doxorubicin Hydrochloride Liposome Injection Combination With Cyclophosphamide vs Pirarubicin Combination With Cyclophosphamide in Patients With Locally Advanced Breast Cancer||Phase 4|
|Recruiting||NCT02913729 - Pre- Versus Postoperative Accelerated Partial Breast Irradiation||N/A|
|Recruiting||NCT02840344 - Couples-Based Mindfulness for Young Breast Cancer Survivors||N/A|
|Recruiting||NCT03080155 - A Study of the 3D MIRA System in Classifying Women at for Likelihood of Breast Cancer||N/A|
|Recruiting||NCT02897544 - Integrative Approaches for Cancer Survivorship 2: Project 2||N/A|
|Recruiting||NCT02934126 - The Development of a Personalized Decision Aid: Perspectives of Patients and Health Care Professionals on Shared Decision Making and Informational Needs on Radiotherapy for Breast Cancer||N/A|
|Recruiting||NCT02897635 - Integrative Approaches For Cancer Survivorship 2: Project 1||N/A|
|Recruiting||NCT02035085 - 19F Hot Spot MRI of Human Adipose-derived Stem Cells for Breast Reconstruction||Phase 1|