Ignite Creation Date:
2024-05-06 @ 2:25 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04318223
Status:
UNKNOWN
Last Update Posted:
2020-03-23
First Post:
2019-12-02
Brief Title:
Palbociclib Plus Fulvestrant in Women With Hormone Receptor Positive and Human Epidermal Growth Factor Receptor Type 2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With a CDK46 Inhibitor in Combination With Hormonal Therapy
Sponsor:
Consorzio Oncotech
Organization:
Consorzio Oncotech
Study Overview
Official Title:
Palbociclib Plus Fulvestrant in Women With Hormone Receptor Positive and Human Epidermal Growth Factor Receptor Type 2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With a CDK46 Inhibitor in Combination With Hormonal Therapy a Multicenter Phase II Trial
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
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:
The aim of the present study is to evaluate the efficacy and safety of palbociclib plus fulvestrant after failure of a combined treatment of hormonal therapy aromatase inhibitor or tamoxifen LHRHa plus a CDK46 inhibitor in women with HR and HER2- LABC or MBC
Primary endpoint
1 To assess the clinical benefit rate CBR of the combination treatment palbociclib plus fulvestrant at progression of a combined treatment of hormonal therapy aromatase inhibitor or tamoxifen LHRHa and a CDK46 inhibitor
Clinical benefit rate for primary efficacy endpoints derivation will be based on the local treating centers radiologistsinvestigators tumor assessment
For patients with measurable disease at baseline progression will be determined according to the RECIST criteria v11
In the absence of measurable disease at baseline patients with bone only lesions lytic or mixed lytic sclerotic will be allowed to enter the study and the following will be considered disease progression among these patients
The appearance of one or more new lytic lesions in bone
The appearance of one or more new lesions outside of bone
Unequivocal progression of existing bone lesions
Note Pathologic fracture new compression fracture or complications of bone metastases will not be considered as evidence of disease progression unless one of the above-mentioned criteria is fulfilled
2 To assess the Quality of Life QoL of patients receiving the combination treatment palbociclib plus fulvestrant at progression of a combined treatment of hormonal therapy aromatase inhibitor or tamoxifen LHRHa and a CDK46 inhibitor
Secondary Endpoints
1 To evaluate the efficacy of the combination of fulvestrant plus palbociclib at the progression of a combined treatment of hormonal therapy aromatase inhibitor or tamoxifen LHRHa and CDK46 inhibitors with respect to
Overall response rate ORR
Progression Free Survival PFS
Overall Survival OS
Safety and tolerability
2 To assess predictive biomarkers of responseresistance to fulvestrant plus palbociclib using metastatic tumor tissue samples and liquid biopsies
This study will be performed in pre- and post-menopausal women with HRHER2- LABC or MBC whose disease is progressing to a CDK46 inhibitor in combination with hormonal therapy aromatase inhibitor or tamoxifen LHRHa
Patients enrolled will receive study medication until disease progression unacceptable toxicity withdrawal of consent or death whichever comes first
Primary endpoint
1 To assess the clinical benefit rate CBR of the combination treatment palbociclib plus fulvestrant at progression of a combined treatment of hormonal therapy aromatase inhibitor or tamoxifen LHRHa and a CDK46 inhibitor
Clinical benefit rate for primary efficacy endpoints derivation will be based on the local treating centers radiologistsinvestigators tumor assessment
For patients with measurable disease at baseline progression will be determined according to the RECIST criteria v11
In the absence of measurable disease at baseline patients with bone only lesions lytic or mixed lytic sclerotic will be allowed to enter the study and the following will be considered disease progression among these patients
The appearance of one or more new lytic lesions in bone
The appearance of one or more new lesions outside of bone
Unequivocal progression of existing bone lesions
Note Pathologic fracture new compression fracture or complications of bone metastases will not be considered as evidence of disease progression unless one of the above-mentioned criteria is fulfilled
2 To assess the Quality of Life QoL of patients receiving the combination treatment palbociclib plus fulvestrant at progression of a combined treatment of hormonal therapy aromatase inhibitor or tamoxifen LHRHa and a CDK46 inhibitor
Secondary Endpoints
1 To evaluate the efficacy of the combination of fulvestrant plus palbociclib at the progression of a combined treatment of hormonal therapy aromatase inhibitor or tamoxifen LHRHa and CDK46 inhibitors with respect to
Overall response rate ORR
Progression Free Survival PFS
Overall Survival OS
Safety and tolerability
2 To assess predictive biomarkers of responseresistance to fulvestrant plus palbociclib using metastatic tumor tissue samples and liquid biopsies
This study will be performed in pre- and post-menopausal women with HRHER2- LABC or MBC whose disease is progressing to a CDK46 inhibitor in combination with hormonal therapy aromatase inhibitor or tamoxifen LHRHa
Patients enrolled will receive study medication until disease progression unacceptable toxicity withdrawal of consent or death whichever comes first
Detailed Description:
This is a Phase II multicentre single-arm study following a Simons two-stage optimal design
Screening phase At screening the investigator or hisher authorized designee will assign a unique number to patients being considered for the study The patient should provide a signed Informed Consent Form prior to any study screening evaluations Once the patient Informed Consent Form has been signed and eligibility is confirmed all inclusionexclusion criteria has been verified the patient can be enrolled All screening evaluations will be performed within 28 days prior to Treatment Day 1 Patients may be re-screened
Treatment phase Eligible patients will receive Fulvestrant plus palbociclib Patients will be treated with fulvestrant 500 mg im on Days 1 15 and 29 and every 28 days thereafter and palbociclib125 mg oral day 1 to 21 every 28 days
Dose adjustment reduction interruption according to toxicity of study treatment will be allowed Study treatment will continue until one of the following conditions apply - whichever comes first
tumor progression
unacceptable toxicity according to investigators judgment
death
discontinuation from the study for any other reason Further treatments after discontinuation will be at the investigators discretion During the study visits will be performed monthly and at the end of treatment Tumor assessment will be performed every 3 cycle of treatment
For each patient enrolled in the present study a blood sample mandatory at study enrollment and at disease progression mandatory will be provided Additionally a tissue sample from the most accessible metastatic site will be collected at study enrollment and at disease progression optional Blood and tumor samples will be used to investigate the mechanisms of response and resistance to therapy with palbociclib in combination with fulvestrant
Screening phase At screening the investigator or hisher authorized designee will assign a unique number to patients being considered for the study The patient should provide a signed Informed Consent Form prior to any study screening evaluations Once the patient Informed Consent Form has been signed and eligibility is confirmed all inclusionexclusion criteria has been verified the patient can be enrolled All screening evaluations will be performed within 28 days prior to Treatment Day 1 Patients may be re-screened
Treatment phase Eligible patients will receive Fulvestrant plus palbociclib Patients will be treated with fulvestrant 500 mg im on Days 1 15 and 29 and every 28 days thereafter and palbociclib125 mg oral day 1 to 21 every 28 days
Dose adjustment reduction interruption according to toxicity of study treatment will be allowed Study treatment will continue until one of the following conditions apply - whichever comes first
tumor progression
unacceptable toxicity according to investigators judgment
death
discontinuation from the study for any other reason Further treatments after discontinuation will be at the investigators discretion During the study visits will be performed monthly and at the end of treatment Tumor assessment will be performed every 3 cycle of treatment
For each patient enrolled in the present study a blood sample mandatory at study enrollment and at disease progression mandatory will be provided Additionally a tissue sample from the most accessible metastatic site will be collected at study enrollment and at disease progression optional Blood and tumor samples will be used to investigate the mechanisms of response and resistance to therapy with palbociclib in combination with fulvestrant
Study Oversight
Has Oversight DMC:
None
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?:
None