Ignite Creation Date:
2024-05-06 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03571633
Status:
RECRUITING
Last Update Posted:
2023-01-10
First Post:
2018-06-04
Brief Title:
Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2 Breast Cancer Breast Cancer
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
A Multicenter Randomized Open-label Phase II Trial Aiming to Evaluate the Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2 Positive Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-08
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:
BREASTIMMU02
Brief Summary:
First preclinical data suggest that pegfilgrastim could constitute a potent adjuvant for immunotherapy with mAb possessing ADCCADCP properties as trastuzumab Combined treatment of pegfilgrastim and trastuzumab should translate into an increased rate of pathological clinical response Therefore the investigators proposal is to evaluate the clinical and biological impact of pegfilgrastim in combination with trastuzumab paclitaxel in HER2-positive early stage breast cancer patients Breastimmune02 is a multicenter randomized open-label Phase II trial Operable HER2 breast cancer patients previously treated with 4 cycles of standard adriamycinecyclophosphamide AC chemotherapy will be randomized 11 to receive in the neoadjuvant settingArm A weekly paclitaxel trastuzumab every 3 weeks Q3W pegfilgrastim Q3W versus Arm B weekly paclitaxel trastuzumab Q3WStratification criteria will be cN0 versus cN1
Detailed Description:
The duration of the neoadjuvant treatment period is planned to be 12 weeks 4 cycles of 3 weeks except in case of Inacceptable toxicity or Patient decision or Withdrawal of consent or Clinicalradiological signs of disease progressionThis neoadjuvant treatment period will be ended with a short term safety visit STSVNeo to be scheduled 28 days after the last dose of study treatments considering the latest study treatments administered Following the STSVNeo patients will undergo surgery as per usual practice and pathological response will be centrally assessed by a referent pathologist blinded for the treatment armsFollowing surgery all patients will be treated in the adjuvant setting with trastuzumab administered every 3 weeks for up to 12 months in both arms with clinical assessments every 3 months cf Réseau régional de Cancérologie httpespacecancersante-rafrPagesAccueilaspx In case of RH disease endocrine therapy may be initiated as per standard treatment guidelinesThis adjuvant treatment period is planned for a maximum of 12 months except in case of Inacceptable toxicity or Patient decision or Withdrawal of consent or Clinicalradiological signs of disease progression All randomized and treated patients will be followed-up for relapse and survival for at least 15 months post-randomization ie 1 year post-surgery
A total of 90 patients will be randomized in the study 45 per arm All the data concerning the patients will be recorded in the electronic case report form eCRF throughout the study serious adverse event SAE reporting will be also paper-based by e-mail andor Fax The sponsor will perform the study monitoring and will help the investigators to conduct the study in compliance with the clinical trial protocol Good Clinical Practices GCP and local law requirements
A total of 90 patients will be randomized in the study 45 per arm All the data concerning the patients will be recorded in the electronic case report form eCRF throughout the study serious adverse event SAE reporting will be also paper-based by e-mail andor Fax The sponsor will perform the study monitoring and will help the investigators to conduct the study in compliance with the clinical trial protocol Good Clinical Practices GCP and local law requirements
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-002069-22 | EUDRACT_NUMBER | None | None |