Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483223
Status:
COMPLETED
Last Update Posted:
2017-08-25
First Post:
2007-06-05
Brief Title:
Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63p73 as a Biomarker of Response
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase II Study of Cisplatin or Carboplatin for Triple-Negative Metastatic Breast Cancer and Evaluation of p63p73 as a Biomarker of Response
Status:
COMPLETED
Status Verified Date:
2017-07
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:
None
Brief Summary:
The purpose of this research study is to
Determine how effective cisplatin or carboplatin is in slowing the time it takes for ER negative estrogen-receptor-negative PR negative progesterone receptor-negative HER2 negative human epidermal growth factor receptor 2 breast cancer to progress Cisplatin and carboplatin are anti-cancer chemotherapy drugs that stop cancer cells from growing abnormally and is used to treat other cancers
Evaluate a new biomarker to help determine which breast cancers are most likely to respond to cisplatin chemotherapy
The hypothesis is that Triple Negative metastatic breast cancer may be particularly sensitive to platinum and that a subgroup of those patients may have a marker in their tumors that predicts response
Determine how effective cisplatin or carboplatin is in slowing the time it takes for ER negative estrogen-receptor-negative PR negative progesterone receptor-negative HER2 negative human epidermal growth factor receptor 2 breast cancer to progress Cisplatin and carboplatin are anti-cancer chemotherapy drugs that stop cancer cells from growing abnormally and is used to treat other cancers
Evaluate a new biomarker to help determine which breast cancers are most likely to respond to cisplatin chemotherapy
The hypothesis is that Triple Negative metastatic breast cancer may be particularly sensitive to platinum and that a subgroup of those patients may have a marker in their tumors that predicts response
Detailed Description:
This study is a Phase 2 study designed to evaluate cisplatincarboplatin as first or second line therapy in metastatic triple negative ER negative PR negative Her2 Negative breast cancer and to evaluate the expression of p63p73 as a biomarker to predict response
Participants will be given a cisplatin or carboplatin infusion intravenously on the first day of each treatment cycle Each treatment cycle will last 3 weeks Treating physician will select agent up to 41 patients in each cohort Final primary endpoint analysis will use combined ciscarbo results
During all treatment cycles participants will have a physical exam including weight and vital signs and they will be asked general questions about their health and any medications they may be taking as well as specific questions about any side effects they may be experiencing while receiving study treatment
During every treatment cycle participants will have standard blood tests to check blood counts liver and kidney function and a blood marker for you particular type of cancer
CT scans will be taken of the participants tumor every 2 to 3 cycles to assess the response of the tumor to cisplatin
Participants will be in this study for as long as they tolerate the study treatment and their disease does not get any worse
Participants will be required to have a sample of their original tumor sent to Massachusetts General Hospital for correlative studies or a sample from a metastatic diagnostic biopsy
Patients with accessible tumor will be asked to provide an optional metastatic tumor biopsy for correlative studies
Participants will be given a cisplatin or carboplatin infusion intravenously on the first day of each treatment cycle Each treatment cycle will last 3 weeks Treating physician will select agent up to 41 patients in each cohort Final primary endpoint analysis will use combined ciscarbo results
During all treatment cycles participants will have a physical exam including weight and vital signs and they will be asked general questions about their health and any medications they may be taking as well as specific questions about any side effects they may be experiencing while receiving study treatment
During every treatment cycle participants will have standard blood tests to check blood counts liver and kidney function and a blood marker for you particular type of cancer
CT scans will be taken of the participants tumor every 2 to 3 cycles to assess the response of the tumor to cisplatin
Participants will be in this study for as long as they tolerate the study treatment and their disease does not get any worse
Participants will be required to have a sample of their original tumor sent to Massachusetts General Hospital for correlative studies or a sample from a metastatic diagnostic biopsy
Patients with accessible tumor will be asked to provide an optional metastatic tumor biopsy for correlative studies
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 |
|---|---|---|---|
| TBCRC009 | OTHER | Translational Breast Cancer Research Consortium | None |