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Anyone BRCA neg and on a PARPi?

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    Posted: Jan 05 2011 at 9:10am
Hi all,
 
I'm writing for a very good friend of mine at work whose wife is triple neg, brca -.  She has mets and is a stage 4, and  battling Triple Negative Agressive High Grade Lobular Breast since Sept 2009 and the beast has mestatized on her chest skin thus making her a "stage 4".  I have directed him to the clinical trial matching service on this site.
 
I'm wondering if anyone else out there is BRCA neg and is on any trials.  She has been thru ACT, Avastin, radiation.  The beast has laughed at all she has tried.  He was told by her onc that she doesn't qualify for a PARPi as she's brca neg.  She is on a trial now, although I don't know the specifics of the regimen.  Will try to get this info.
 
Any info you could pass along would be awesome.  My heart breaks for my friend....his wife has given up completely and I know that is a personal decision.  She refuses to change oncs, won't look into MD Anderson, CTCA or anything like that....they life in central NJ and she even refuses to go to the Sloan center in NJ (where I go).  She's had a rough time with all treatment, and of course being in treatment myself, I understand this, but each of us has to find the fight in ourselves.  As I have said previously, when you have cancer, it's about acceptance....everyone takes a long time to get to that, but once you find peace with your decision, you forge onward.  He and I have become very close as he has been going thru this with his wife and I just feel like anything I can help him with would be of a little bit of value.
 
Thank you from my heart.
 
love,
mary ellen
2008 BRCA 1+ dx stg 1,gr 3 IDC triple neg. BM w/ recon. CT x 4. Prophy TAH 2007. Recurrence 9/13/10. 10/5/10 tumor excised. ACx4, Taxol x3, abraxane x 9. 38 rads. 7/11 NED!!!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote zoomommy2 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 9:23am

Donna is BRCA - and on the PARPI trial.

Lee
dx6/09,stageII,gr3,(L)mastectomy 7/09,ACx4,Taxolx7,Avastin study,gall bladder surgery 1/10,4/11 Stage 4, mets to lung, 4/11 Started Taxotere and Xeloda, 5/11 Taxotere stopped, off Xeloda
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i am triple neg brca + treated at columbia pres medical ctr in nyc.  with parp abt 888.  the other person on the study with me has not tested for the brca gene mutation and does not have the family history.  I have had many problems with previous treatment for mets however after the first cycle I can say that this treatment is very manageable.  below is the trial description with contact info.


Breast-Female

ID:AAAF2754

Externally Peer Reviewed
Principal Investigator: Dr. Dawn Hershman

Adult: PHASE I STUDY OF ABT-888, PARP INHIBITOR, AND PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) IN RECURRENT GYNECOLOGIC CANCER AND BREAST CANCER

This is a Phase I clinical trial of ABT-888 for subjects who have recurrent or residual epithelial ovarian cancer, primary peritoneal carcinoma or Fallopian tube carcinoma, OR metastatic or locally advanced inoperable breast cancerThe purpose of this study is to test the safety of ABT-888, an oral PARP inhibitor, at different dose levels in combination with a standard chemotherapy drug pegylated liposomal doxorubicin (PLD). PARP inhibitors work by enhancing the effects of chemotherapy in killing cancer cells. ABT-888 is an experimental drug that is not commercially available or approved. PLD is a commercially available drug that is not experimental, and which is approved for the treatment of ovarian cancer; it is also commonly used to treat breast cancer We want to find out what effects, good and/or bad, it has on you and your epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, OR metastatic or locally advanced inoperable breast cancer.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 10:10am
Dear Mary Ellen,

it’s interesting that your friend was told that she had to be BRCA+ to be in a parp trial. I spoke to a woman yesterday who was told the same thing by her oncologist.

That was/is not my understanding about the parp trial that is currently enrolling patients under a random selection(lottery) program...The sites offering the “expanded access” program are the same sites where the clinical trial took place, according to Theresa (please see below).


It is my understanding that you do not have to be BRCA+ to be in this trial. You do have to have metastatic TNBC.

Theresa confirmed that this trial is open and enrolling patients.

I pulled up the trial on clinicaltrials.gov and called the number listed and was given the number for National Organization of Rare Disorders (NORD) the organization that is answering some questions about the trial. I spoke to a Theresa in the patient screening center. 1-800-999-6673 x 206. She would be happy to speak to anyone who is interested.

Theresa said there are five things she asks the patient about.

1. do you have metastatic TNBC?
2. are you 18 or over?
3. are you pregnant or breast feeding? (that would exclude a woman from participating)
4. have you had chemo since your were metastatic? if the answer is yes so further details need to be ascertained but it would not necessarily exclude a woman from the trial.
5. are you currently able to receive chemo?

If there are any further medical questions Theresa refers the prospective enrollee to the site and she also can tell women where the sites are and provide phone numbers to the specific sites. It is suggested, when you ask questions, that you refer to 

ClinicalTrials.gov Identifier:NCT01130259
Theresa was very friendly, helpful and seem knowledgeable to me.

all the best,

Steve

p.s. you have to make sure, with your oncologist that you meet the criteria below and I am not a doctor. I am not recommending that anyone try to enter this trial. Just trying to correct information some oncologists are giving out..

An Open-Label, Expanded Access Protocol of Iniparib Breast Cancer
Expanded access is currently available for this treatment.
Verified by BiPar Sciences, December 2010
First Received: May 24, 2010   Last Updated: December 14, 2010   History of Changes
Sponsor:BiPar Sciences
Information provided by:BiPar Sciences
ClinicalTrials.gov Identifier:NCT01130259
  Purpose

The following trial is designed to offer pre-approval drug access to iniparib in combination with gemcitabine and carboplatin in order to provide potential clinical benefit to patients with ER-, PR-, and HER2-negative metastatic breast cancer. This follows an ongoing Phase 3, multi-center, open-label, randomized study of gemcitabine/carboplatin, with or without iniparib, in patients with ER-, PR-, and HER2-negative metastatic breast cancer (protocol 20090301).


ConditionIntervention
Breast Cancer
Drug: iniparib

Study Type:Expanded Access     What is Expanded Access?
Official Title:An Open-Label, Expanded Access Protocol of Iniparib in Combination With Gemcitabine/Carboplatin in Patients With ER-, PR-, and HER2-Negative Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by BiPar Sciences:

Intervention Details:
    Drug: iniparib
    5.6 mg/kg as a 60 (±10) minutes IV infusion. Administered on Days 1, 4, 8, and 11 of each 21 day cycle.
    Other Name: BSI-201
  Eligibility

Ages Eligible for Study:  18 Years and older
Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

  • Histologically documented breast cancer (either primary or metastatic site) that is ER-negative, PR-negative, and HER2 non-over expressing
  • Zero to three prior chemotherapy regimens in the metastatic setting
  • Metastatic breast cancer (Stage IV)
  • Female, ≥18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  • Organ and marrow function as follows: absolute neutrophil count (ANC) ≥1500/mm3, platelets ≥100,000/dL, hemoglobin ≥9 g/dL, bilirubin ≤1.5 mg/dL, serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper limit of normal with liver involvement
  • For women of child bearing potential, documented negative pregnancy test within two weeks of EAP entry and agreement to acceptable birth control during the duration of the EAP therapy
  • Capability to understand and comply with the protocol and signed informed consent document

Exclusion Criteria:

  • Systemic anticancer therapy within 14 days of the first dose of study drug
  • Has not recovered to grade ≤1 from adverse events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v3.0, with the exception of alopecia, related to anticancer therapy prior to the first dose of study drug
  • Major medical conditions that might affect EAP participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease)
  • Brain metastases requiring steroids or expected to require other therapeutic intervention during study participation, including WBRT and intrathecal therapy. Patients must be > 21-days from neurosurgical intervention
  • Pregnant or breastfeeding
  • Inability or unwillingness to abide by the EAP protocol or cooperate fully with the investigator or designee

Enrollment is limited and will be determined by a validated Random-Selection Process administered by NORD (National Organization of Rare Disorders).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130259

Contacts
Contact: sanofi-aventis Call Center866-668-2232

Sponsors and Collaborators
BiPar Sciences
  More Information

No publications provided 

Responsible Party:BiPar Sciences ( Chuck Bradley, Vice President Clinical Development )
ClinicalTrials.gov Identifier:NCT01130259     History of Changes
Other Study ID Numbers:2010EAP
Study First Received:May 24, 2010
Last Updated:December 14, 2010
Health Authority:United States: Food and Drug Administration




Edited by steve - Jan 05 2011 at 10:56am
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
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Momof2NJ Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 10:18am
Thank you all so much...and especially you Steve....your kindness and willingness to help us always warms my heart.
 
I'm sending my friend all of the info and he is very grateful. 
 
love,
mary ellen
2008 BRCA 1+ dx stg 1,gr 3 IDC triple neg. BM w/ recon. CT x 4. Prophy TAH 2007. Recurrence 9/13/10. 10/5/10 tumor excised. ACx4, Taxol x3, abraxane x 9. 38 rads. 7/11 NED!!!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 10:48am
Dear Mary Ellen,

thanks for your kind words..

Please tell your friend that, from my experience with TN women on this trial...sometimes it seems to work wonderfully and sometimes it does not..

all the best,

Steve
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
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Post Options Post Options   Thanks (0) Thanks(0)   Quote harbin Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 10:54am
Hi Mary Elleen, I am BRCA- and in the trial Steve mentioned above. I know few people in the same place where I have been treated are alow BRCA-. It's very kind of you trying to help your friend. Best luck to her.
4/08 dx IDC,stg2,neg. nodes,4xAC,8xTexol& Avastin,BRCA-
3/10 Recurr Chestwall,surgery
6/10 Lung mets
10/10 Parp
05/11 Surgery on 2 lung nodules
08/11 Parp failed
10/11 Cyberknife 1 lung nodule
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Tonya98 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 10:58am
I'm in the trial too and not brca+.
 
 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote sstefano Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 11:37am
Do you know how I can find out where the Expanded Access Protocol of Iniparib trial is available?
 
Thanks!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 11:50am
Dear sstefano,

from my post above-

I spoke to a Theresa in the patient screening center. 1-800-999-6673 x 206. She would be happy to speak to anyone who is interested.

S., please let me know if you have any problems getting information..I just sent you my contact info in a PM.

good luck!!!

all the best,

Steve


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
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Post Options Post Options   Thanks (0) Thanks(0)   Quote trip2 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 1:54pm
Linderella welcome and thank you for sharing.  We look forward to hearing more from you. It's great to hear your treatment is very manageable.
Stage 2 2003
Stage 1 2007
BRCA 1+
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Post Options Post Options   Thanks (0) Thanks(0)   Quote sstefano Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 4:39pm
Steve,
 
Theresa was very kind and she gave me the information that I needed.
 
Thanks for your help!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 4:52pm
great, S.!!!

thanks for the feedback...

all the best,

Steve
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
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Post Options Post Options   Thanks (0) Thanks(0)   Quote ja Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 5:26pm
I am BRCA neg & on PARP trial. I am non-metastatic, but know that metastatic trial has been offered too, but not sure if still open. I was told the trial I'm in filled up quickly. I know there were patients who even flew in from out of state. My trial was run by Indiana University Medical/Simon Cancer Center. Dr Kathy Miller is one of the principle research docs & awesome.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote trip2 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 7:18pm
Hello ja and welcome.
Stage 2 2003
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2011 at 7:20pm
Mary Ellen,

I'm in the Iniparib parp clinical trial with gemzar/carboplatin (BSI-201) Expanded Access Protocol, and I'm BRCA negative.

Donna
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

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Momof2NJ Quote  Post ReplyReply Direct Link To This Post Posted: Jan 06 2011 at 9:00am
Thank you everyone....This info has proved very beneficial and my friends wife may be able to get into a trial.  I appreciate you all taking the time to respond.
 
much love,
mary ellen
2008 BRCA 1+ dx stg 1,gr 3 IDC triple neg. BM w/ recon. CT x 4. Prophy TAH 2007. Recurrence 9/13/10. 10/5/10 tumor excised. ACx4, Taxol x3, abraxane x 9. 38 rads. 7/11 NED!!!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Jan 06 2011 at 11:15am
Dear Mary Ellen,

I think your friend is very fortunate to have you as a friend, as are we.

Good luck to her!!!!

all the best,

Steve
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
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Post Options Post Options   Thanks (0) Thanks(0)   Quote zacar Quote  Post ReplyReply Direct Link To This Post Posted: Jan 07 2011 at 1:32pm
I am also on the open access study and am BRCA negative.

Caryn C.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote butterfly Quote  Post ReplyReply Direct Link To This Post Posted: Jan 12 2011 at 6:47am
Yes was on PARPi for 27 months,stopped two weeks ago.BRCA neg
 
 
Diagnosed primary bc 05. surgery,chemo (AC, Taxo).rads.
March 2008 Diagnosedmets-lung,lymph nodes
Oct 08-Jan 11 PARPi Trial, (oral)with taxol then PARPi alone.
Jan 2011 Xeloda
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