Ignite Creation Date:
2024-05-06 @ 3:10 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02229149
Status:
TERMINATED
Last Update Posted:
2022-12-02
First Post:
2014-08-27
Brief Title:
Phase 2 Study of Standard Chemotherapy With Trastuzumab Plus or Minus Pertuzumab for Pre-treated Metastatic Breast Cancer
Sponsor:
US Oncology Research
Organization:
US Oncology Research
Study Overview
Official Title:
Randomized Phase II Trial of Chemotherapy of Physicians Choice Plus Trastuzumab Versus Chemotherapy of Physicians Choice Plus Trastuzumab Plus Pertuzumab In Women With Pretreated HER2-Overexpressing Metastatic Breast Cancer MBC
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
per Sponsor request
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase 2 study will seek to determine the effectiveness of chemotherapy physicians choice of vinorelbine taxane paclitaxel docetaxel or nab paclitaxel or capecitabine plus trastuzumab vs chemotherapy physicians choice plus trastuzumab plus pertuzumab in women with HER2-overexpressing metastatic breast MBC that has been previously treated with ado-trastuzumab emtansine T-DM1 in the metastatic setting
Detailed Description:
The current preferred first-line therapy for patients with HER2-overexpressing metastatic breast cancer MBC is a taxane plus trastuzumab plus pertuzumab based on results from the CLEOPATRA trial For patients with disease that has progressed on trastuzumab and a taxane ado-trastuzumab emtansine T-DM1 was recently approved based on results from the EMILIA trial showing superiority in this setting compared with capecitabine plus lapatinib However the standard for first-line therapy may change again in the near future when results become available from the MARIANNE trial which is evaluating T-DM1 alone or in combination with pertuzumab as upfront therapy Two important questions that may be raised by the findings of this study are whether pertuzumab is effective as second- or later-line therapy following single-agent T-DM1 and whether pertuzumab administered beyond progression on prior pertuzumab therapy is of clinical benefit as trastuzumab has been proven to be
The study will seek to determine the efficacy of chemotherapy physicians choice of vinorelbine taxane paclitaxel docetaxel or nab paclitaxel or capecitabine plus trastuzumab vs chemotherapy physicians choice plus trastuzumab plus pertuzumab in women with HER2-overexpressing MBC that has been previously treated with T-DM1 in the metastatic setting
We hypothesize that the addition of pertuzumab to trastuzumab plus chemotherapy will improve median progression-free survival PFS compared to trastuzumab plus chemotherapy alone as second- or later-line therapy in patients who have received prior T-DM1 Patients will be stratified according to whether they have received prior pertuzumab versus not We will also explore whether continuing treatment with pertuzumab in patients who have been previously treated with pertuzumab improves PFS
The study will seek to determine the efficacy of chemotherapy physicians choice of vinorelbine taxane paclitaxel docetaxel or nab paclitaxel or capecitabine plus trastuzumab vs chemotherapy physicians choice plus trastuzumab plus pertuzumab in women with HER2-overexpressing MBC that has been previously treated with T-DM1 in the metastatic setting
We hypothesize that the addition of pertuzumab to trastuzumab plus chemotherapy will improve median progression-free survival PFS compared to trastuzumab plus chemotherapy alone as second- or later-line therapy in patients who have received prior T-DM1 Patients will be stratified according to whether they have received prior pertuzumab versus not We will also explore whether continuing treatment with pertuzumab in patients who have been previously treated with pertuzumab improves PFS
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ML29212 | OTHER | Genentech Inc | None |