Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-30 @ 4:20 PM
Study NCT ID:
NCT03712956
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2018-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer BREAST CANCER
Sponsor:
European Institute of Oncology
Organization:
Study Overview
Official Title:
CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer: a Feasibility Phase II Trial
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
A single-center, phase II, single-arm, feasibility study to evaluate PLD (Caelyx®) as an adjuvant chemotherapy regimen in patients with early-stage luminal B breast cancer.
The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment.
Caelyx® should be administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.
The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment.
Caelyx® should be administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.
Detailed Description:
In the 2011 St Gallen Consensus Conference, the Panel considered that both anthracyclines and taxanes should be included in the chemotherapy regimen for 'Luminal B' disease1. However, several patients are reluctant to receive a "strong" chemotherapy because of the fear of its toxic effects, and usually ask for a somehow "less intensive" approach, even accepting a possible reduction in the treatment efficacy.
One of the reasons why patients refuse chemotherapy more often is the fear of alopecia. Few dermatologic conditions carry as much emotional distress as chemotherapy-induced alopecia. Hair loss negatively affects a patient's perception of appearance, body image, sexuality, and self- esteem.
We decided to conduct a single-center, phase II, single-arm, feasibility study to evaluate PLD (Caelyx®) as an adjuvant chemotherapy regimen in patients with early-stage luminal B breast cancer.
The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment.
Secondary endpoints will include:
* Adverse events
* Tolerability (treatment completion)
* Breast cancer free interval (BCFI; events are reappearance of invasive breast cancer at any site including contralateral disease)
* Disease Free Survival (DFS) (includes second malignancies and deaths)
* Overall survival (OS) Caelyx® should be administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.
One of the reasons why patients refuse chemotherapy more often is the fear of alopecia. Few dermatologic conditions carry as much emotional distress as chemotherapy-induced alopecia. Hair loss negatively affects a patient's perception of appearance, body image, sexuality, and self- esteem.
We decided to conduct a single-center, phase II, single-arm, feasibility study to evaluate PLD (Caelyx®) as an adjuvant chemotherapy regimen in patients with early-stage luminal B breast cancer.
The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment.
Secondary endpoints will include:
* Adverse events
* Tolerability (treatment completion)
* Breast cancer free interval (BCFI; events are reappearance of invasive breast cancer at any site including contralateral disease)
* Disease Free Survival (DFS) (includes second malignancies and deaths)
* Overall survival (OS) Caelyx® should be administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: