Go To Main TNBC Website


  New Posts New Posts RSS Feed - novel parp trial from MD Anderson Cancer Center
  FAQ FAQ  Forum Search   Events   Register Register  Login Login

novel parp trial from MD Anderson Cancer Center

 Post Reply Post Reply
Author
SagePatientAdvocates View Drop Down
Senior Member
Senior Member
Avatar

Joined: Apr 15 2009
Status: Offline
Points: 4454
Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Topic: novel parp trial from MD Anderson Cancer Center
    Posted: Mar 12 2015 at 6:52am


Dear TNBC Family,

There are many in our TNBC family who have inherited the BRCA mutation and developed breast/ovarian cancer and the breast cancer was often TNBC. This is not a trial for those women but it is an important opportunity for others (as explained below) to be able to get a parp inhibitor, BMN 673..

As an example, I carry the BRCA mutation (the inherited type). If I were to develop e.g. progressive prostate cancer I would be eligible to get the drug. If a BRCA+ woman with progressive pancreatic cancer, but no breast or ovarian cancer, would also be able get the drug. I think this post is important for examples like this and I know they are out there, in our community. 

I strongly recommend that anyone who wants to understand more call the study coordinator at MDACC who is 

Rabia Khan

Office Number:  713-563-4667

Email:  rkhan@mdanderson.org

warmly,

Steve


The following information I received from MD Anderson Cancer Center today is as follows-

MD Anderson Cancer Center has begun enrolling on a “Phase II Study of the PARP Inhibitor BMN 673 (Talazoparib tosylate) in Advanced Cancer Patients with Somatic Alterations in BRCA1/2, Mutations/Deletions in PTEN or PTEN Loss, a Homologous Recombination Defect, Mutations/Deletions in Other BRCA Pathway Genes and Germline Mutation in BRCA1/2 (Not Breast or Ovarian Cancer).”  The Clinical Trials.gov identifier is NCT02286687.

 

PARP inhibitors have already been shown to have efficacy in ovarian cancer patients with germline BRCA1 or 2 mutations, and there are trials with PARP inhibitors ongoing in breast cancer patients with germline BRCA1 or 2 mutations. Studies have shown several other genomic changes occur in tumors that may affect the tumors’ DNA damage repair ability.  It is not yet known whether PARP inhibitors are effective in patients with these alterations or if PARP inhibitors are effective in patients with germline BRCA1 or 2 mutations in cancers other than breast and ovarian cancer.

 

This study is designed to learn if the PARP inhibitor talazoparib tosylate can help control advanced cancer in patients who have specific types of genomic alterations shown in the table below.  The safety of this drug will also be studied.

 

The study is only enrolling at MD Anderson Cancer Center.  Dr. Sarina A.  Piha- Paul is the principal investigator.  Dr. Funda Meric-Bernstam is the co-principal investigator.  Rosa Mostorino and Wendy Xiong are the clinical study coordinators; however, Rabia Khan will be serving as the primary point of contact for the study.  Her contact information is as follows:

 

Rabia Khan

Office Number:  713-563-4667

Email:  rkhan@mdanderson.org

 

In order to be considered for enrollment, patients must have one of the following genomic alterations:

 

Cohort

Mutation/

Alteration*

Included

Excluded

(if known)

Other Exclusions

(if applicable)

1

Somatic Mutations ofBRCA 1 / 2

N/A

N/A

Not Breast or Ovarian Cancer with GermlineBRCA Mutations

2

Homologous Deletions ofBRCA 1 / 2

N/A

N/A

Not Breast or Ovarian Cancer with GermlineBRCA Mutations

3

Alterations in Other BRCAPathway Genes

Mutations or Deletions inATM, PALB2, MER11, RAD50, NBS1,

ATR; Fanconi Anemia Genes;

Or Amplification of EMSY,

N/A

Not Breast or Ovarian Cancer with GermlineBRCA Mutations

4

Mutations or Deletions inPTEN; Loss of PTEN by IHC

N/A

N/A

Not Breast or Ovarian Cancer with GermlineBRCA Mutations

5

Homologous Recombination Defects (Myriad HRD assay LOH >42)

BRCA methylation; somatic DNA alterations

N/A

Not Breast or Ovarian Cancer with GermlineBRCA Mutations

6

Germline Mutations ofBRCA 1/2

N/A

N/A

Not Breast or Ovarian Cancer

*mutations or alterations predicted to be deleterious

 

Note:  germline mutations are those which someone is born with.  They are passed down from your parents and to your offspring.  Somatic mutations develop in tumors and are not inherited or passed on to offspring.

 

BMN673 will be dosed at 1 mg by mouth daily for a 28 day cycle.  Visits during the first cycle will be weeklyand then they will be monthly.  The trial requires 2 biopsies and archival tissue availability. Tumor assessment will be done every 8 weeks.

 

 Key eligibility criteria:

1.     Confirmed diagnosis of solid tumor pre-identified to have a qualifying genomic alteration as per table 1.  

2.     Primary central nervous system (CNS) tumors are excluded; however, metastatic tumors to the CNS may participate if –

o   4 weeks from prior therapy completion (including radiation or surgery)

o   Clinically stable with respect to CNS tumor at the time of study entry

o   Not receiving steroid therapy

o   Not receiving anti-convulsive meds (started for brain mets)

o   Patient may not have leptomeningeal involvement

3.     Good performance status

4.     Adequate organ function

5.     Patient is in need of treatment because of progression or relapse.

6.     Patient must have measurable disease.

             

Common drug-related adverse events include fatigue, nausea, alopecia, anemia, thrombocytopenia and neutropenia.

 

Please contact Rabia Khan if you have any questions. 

 

Additionally you can contact the Clinical Center for Targeted Therapy Business Center for new patient appointments at 713-792-1160.

I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates
Back to Top
123Donna View Drop Down
Senior Member
Senior Member
Avatar

Joined: Aug 24 2009
Location: St. Louis, MO
Status: Offline
Points: 12851
Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 21 2017 at 8:04am

PARP inhibitor can be new treatment option for patients with metastatic breast cancer, BRCA mutations

In a randomized, Phase III trial led by researchers at The University of Texas MD Anderson Cancer Center, the PARP inhibitor talazoparib extended progression-free survival (PFS) and improved quality-of-life measures over available chemotherapies for patients with metastatic HER2-negative breast cancer and mutations in the BRCA1/2 genes.

The results of the EMBRACA trial were presented today at the 2017 San Antonio Breast Cancer Symposium by Jennifer Litton, M.D., associate professor of Breast Medical Oncology.

"The trial found that talazoparib provides a significant clinical benefit to all patient subgroups, including those with hormone receptor-positive and triple-negative disease," said Litton. "The results of this trial are quite exciting and indicate talazoparib is a novel treatment option for patients with metastatic breast cancer and BRCA mutations."

To read the entire article:
https://www.news-medical.net/news/20171208/PARP-inhibitor-can-be-new-treatment-option-for-patients-with-metastatic-breast-cancer-BRCA-mutations.aspx

DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

Back to Top
 Post Reply Post Reply
  Share Topic   

Forum Jump Forum Permissions View Drop Down

Forum Software by Web Wiz Forums® version 11.05
Copyright ©2001-2016 Web Wiz Ltd.