Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02894398
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2016-08-25
Brief Title:
Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
Sponsor:
iOMEDICO AG
Organization:
iOMEDICO AG
Study Overview
Official Title:
Open-label Multi-center sINGlE Arm Clinical Study to Evaluate EfficacyQoL in Women With HR HER2- Regionally Recurrent or Metastatic Breast Cancer Receiving Palbociclib With an AI or Fulvestrant After Prior Endocrine Therapy
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INGE-B
Brief Summary:
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
Detailed Description:
This is a prospective open-label multi-center single arm non-comparative phase II study in women with HRHER2- 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 investigators 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 patients 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 samples identification numbers 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
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 investigators 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 patients 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 samples identification numbers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None