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06-13-2012, 04:27 AM
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#1
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Senior Member
Join Date: Oct 2007
Posts: 1,851
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Genentech's TH3RESA trial has many locations
This trial has 199 study locations, with over 50 locations in the U.S. The trial is for HER2+ metastatic survivors who have received at least two prior regimens of HER2-directed therapy. It has two arms: T-DM1 and treatment of physician’s choice. To read more about TH3RESA, visit http://clinicaltrials.gov/ct2/show/NCT01419197
For any patients, caregivers or doctors who are looking for available trials for T-DM1 or Pertuzumab, or if the TH3RESA trial is in a location on the list that’s not yet recruiting, please call Genentech’s Trial Information Support Line at 888-662-6728. The call line is staffed by trained nurses who can discuss available Genentech trials.
Joan
__________________
Diagnosed stage 2b in July 2003 (2.3 cm, HER2+, ER-/PR-, 7+ nodes). Treated with mastectomy (with immediate DIEP flap reconstruction), AC + T/Herceptin (off label). Cancer advanced to lung in Jan. 2007 (1 cm nodule). Started Herceptin every 3 weeks. Lung wedge resection April 2007. Cancer recurred in lung April 2008. RFA of lung in August 2008. 2nd annual brain MRI in Oct. 2008 discovered 2.6 cm cystic tumor in left frontal lobe. Craniotomy Oct. 2008 (ER-/PR-/HER2-) followed by targeted radiation (IMRT). Coughing up blood Feb. 2009. Thoractomy July 2009 to cut out fungal ball of common soil fungus (aspergillus) that grew in the RFA cavity (most likely inhaled while gardening). No cancer, only fungus. Removal of tiny melanoma from upper left arm, plus sentinel lymph node biopsy in Feb. 2016. Guardant Health liquid biopsy in Feb. 2016 showed mutations in 4 subtypes of TP53. Repeat of Guardant Health biopsy in Jana. 2021 showed 3 TP53 mutations, BRCA1 mutation and CHEK2 mutation. Invitae genetic testing showed negative for all of these. Living with MBC since 2007. Stopped Herceptin Hylecta (injection) treatment in March 2020. Recent 2021 annual CT of chest, abdomen and pelvis and annual brain MRI showed NED. Praying for NED forever!!
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06-25-2012, 01:25 PM
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#2
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Senior Member
Join Date: Sep 2010
Location: Shelby, N.C.
Posts: 114
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Re: Genentech's TH3RESA trial has many locations
My wife Barb was enrolled in the Emelia trial and we withdrew when she was randomly assigned the Tykerb leg. Does that constitute prior TDM-1 involvement even though she didnt follow through. I would love to get her in the Th3resa study but it appears she would be excluded. Has any body seen the rules bent in a situation like this Ive called Genentech and am waiting for a response hopefully the wording isnt so literal.
__________________
Diag. Aug. 2010
ER- PR- Her-2 +++ Stage IV
Mets to T 6th Vertabrae
Radiation to spine
10/23/10StartNavelbine
11/19/10 Port installed
11/22/10 Started 2nd cycle
1/10/11 Finished 2nd cycle
1/24/11 Herceptin Only
3/7/11 progression, start Taxol/Herceptin
4/18/11 Skin mets appear increase treatments to weekly
rash spreads to right breast
7/5/11 enroll in TDM-1 study
7/29/11 randomly assigned Tykerb drop out of trial and start Tykerb /Herceptin no Xeloda skin mets gone Tykerb working
1/31/12 Skin mets return add Xeloda
5/9/12 Stop Tykerb skin mets back
5/17/12 Return to Navelbine/Herceptin
6/26/12 start process for TDM-1 compassionate access
8/28/12 Start TDM-1
10/9/12 third TDM-1 no response yet
10/23/12 Start Haloven
1/17/12 Start Perjeta/ Herceptin/Taxotere
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06-26-2012, 08:58 AM
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#3
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Senior Member
Join Date: Sep 2010
Location: Shelby, N.C.
Posts: 114
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Re: Genentech's TH3RESA trial has many locations
Heard from Genentech this morning apparently the wording is strictly enforced Barbs attempt at the Emelia trial will exclude her from the Th3resa study. I guess the only hope we have of getting her TDM-1 is FDA approval or possibly a request from her Oncologist for compassionate use.
__________________
Diag. Aug. 2010
ER- PR- Her-2 +++ Stage IV
Mets to T 6th Vertabrae
Radiation to spine
10/23/10StartNavelbine
11/19/10 Port installed
11/22/10 Started 2nd cycle
1/10/11 Finished 2nd cycle
1/24/11 Herceptin Only
3/7/11 progression, start Taxol/Herceptin
4/18/11 Skin mets appear increase treatments to weekly
rash spreads to right breast
7/5/11 enroll in TDM-1 study
7/29/11 randomly assigned Tykerb drop out of trial and start Tykerb /Herceptin no Xeloda skin mets gone Tykerb working
1/31/12 Skin mets return add Xeloda
5/9/12 Stop Tykerb skin mets back
5/17/12 Return to Navelbine/Herceptin
6/26/12 start process for TDM-1 compassionate access
8/28/12 Start TDM-1
10/9/12 third TDM-1 no response yet
10/23/12 Start Haloven
1/17/12 Start Perjeta/ Herceptin/Taxotere
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06-26-2012, 09:39 AM
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#4
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Senior Member
Join Date: Jan 2012
Location: Boulder Colorado as of January 2013
Posts: 389
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Re: Genentech's TH3RESA trial has many locations
I vote for the Onc and Compassionate use. Are you going to Duke or UNC? Both are good for the compassionate use option. I am in Raleigh and saw both of them but chose to have Nina treated in Houston due to people interaction issues with the above. They are both good locations and I think have access to TDM-1. I would push the local onc hard.
Paul
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06-26-2012, 09:43 AM
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#5
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Senior Member
Join Date: Sep 2010
Location: Shelby, N.C.
Posts: 114
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Re: Genentech's TH3RESA trial has many locations
Paul
We have choosen to stay close to home in Shelby. We both like her Onc. and I really believe in my heart he cares for her. I did'nt think all the traveling to Duke or UNC would be good for her. If we have to travel to get the TDM-1 we will, Ive always felt this is what she needs. Would love to talk to a fellow Tar Heel about the role of caregiver unless of course your a Blue Devil fan LOL
__________________
Diag. Aug. 2010
ER- PR- Her-2 +++ Stage IV
Mets to T 6th Vertabrae
Radiation to spine
10/23/10StartNavelbine
11/19/10 Port installed
11/22/10 Started 2nd cycle
1/10/11 Finished 2nd cycle
1/24/11 Herceptin Only
3/7/11 progression, start Taxol/Herceptin
4/18/11 Skin mets appear increase treatments to weekly
rash spreads to right breast
7/5/11 enroll in TDM-1 study
7/29/11 randomly assigned Tykerb drop out of trial and start Tykerb /Herceptin no Xeloda skin mets gone Tykerb working
1/31/12 Skin mets return add Xeloda
5/9/12 Stop Tykerb skin mets back
5/17/12 Return to Navelbine/Herceptin
6/26/12 start process for TDM-1 compassionate access
8/28/12 Start TDM-1
10/9/12 third TDM-1 no response yet
10/23/12 Start Haloven
1/17/12 Start Perjeta/ Herceptin/Taxotere
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06-28-2012, 10:58 AM
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#6
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Senior Member
Join Date: Sep 2010
Location: Shelby, N.C.
Posts: 114
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Re: Genentech's TH3RESA trial has many locations
I talked to someone at Genentech again today and apparently said something differently this time. They told me to have her Onco. call their medical team to see about access to the Th3resa Study regardless of the previous enrollment. Not sure what to make of all this one person says one thing another says something else. I just want whats best for Barb.
__________________
Diag. Aug. 2010
ER- PR- Her-2 +++ Stage IV
Mets to T 6th Vertabrae
Radiation to spine
10/23/10StartNavelbine
11/19/10 Port installed
11/22/10 Started 2nd cycle
1/10/11 Finished 2nd cycle
1/24/11 Herceptin Only
3/7/11 progression, start Taxol/Herceptin
4/18/11 Skin mets appear increase treatments to weekly
rash spreads to right breast
7/5/11 enroll in TDM-1 study
7/29/11 randomly assigned Tykerb drop out of trial and start Tykerb /Herceptin no Xeloda skin mets gone Tykerb working
1/31/12 Skin mets return add Xeloda
5/9/12 Stop Tykerb skin mets back
5/17/12 Return to Navelbine/Herceptin
6/26/12 start process for TDM-1 compassionate access
8/28/12 Start TDM-1
10/9/12 third TDM-1 no response yet
10/23/12 Start Haloven
1/17/12 Start Perjeta/ Herceptin/Taxotere
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06-28-2012, 05:41 PM
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#7
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Senior Member
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
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Re: Genentech's TH3RESA trial has many locations
Go with the good news.
Its always better to ask for forgiveness than permission.
__________________
Diagnosed 2007
Stage IIb Invasive Ductal Carcinoma, Pagets, 3 of 15 positive nodes
Traditional Treatment: Mastectomy and Axillary Node Dissection followed by Taxotere, 6 treatments and 1 year of Herceptin, no radiation
Former Chemo Ninja "Takizi Zukuchiri"
Additional treatments:
GP2 vaccine, San Antonio Med Ctr
Prescriptive Exercise for Cancer Patients
ENERGY Study, UCSD La Jolla
Reconstruction: TRAM flap, partial loss, Revision
The content of my posts are meant for informational purposes only. The medical information is intended for general information only and should not be used in any way to diagnose, treat, cure, or prevent disease
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07-05-2012, 08:39 AM
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#8
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Senior Member
Join Date: Sep 2010
Location: Shelby, N.C.
Posts: 114
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Re: Genentech's TH3RESA trial has many locations
We recieved a call late Monday afternoon from Barbs Oncologist saying that she has been approved for TDM-1 under compassionate care. Now we are praying our insurance cooperates, they have been known to throw a wrench in the works. At this point I dont care what they do, God will provide as He has faithfully done in the past. Thank you all for the prayers, thoughts, and comments.
__________________
Diag. Aug. 2010
ER- PR- Her-2 +++ Stage IV
Mets to T 6th Vertabrae
Radiation to spine
10/23/10StartNavelbine
11/19/10 Port installed
11/22/10 Started 2nd cycle
1/10/11 Finished 2nd cycle
1/24/11 Herceptin Only
3/7/11 progression, start Taxol/Herceptin
4/18/11 Skin mets appear increase treatments to weekly
rash spreads to right breast
7/5/11 enroll in TDM-1 study
7/29/11 randomly assigned Tykerb drop out of trial and start Tykerb /Herceptin no Xeloda skin mets gone Tykerb working
1/31/12 Skin mets return add Xeloda
5/9/12 Stop Tykerb skin mets back
5/17/12 Return to Navelbine/Herceptin
6/26/12 start process for TDM-1 compassionate access
8/28/12 Start TDM-1
10/9/12 third TDM-1 no response yet
10/23/12 Start Haloven
1/17/12 Start Perjeta/ Herceptin/Taxotere
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07-05-2012, 06:37 PM
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#9
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Senior Member
Join Date: Aug 2010
Location: New York, New York
Posts: 1,580
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Re: Genentech's TH3RESA trial has many locations
Mike,
This is wonderful news. I am hoping things go your and Barb's way, it is SO deserved. Thanks for letting us know.
Warmly,
Karen
__________________
World Trade Center Survivor (56th Floor/North Tower): 14 years and still just like yesterday.
Graves Disease, became Euthyroid via Radioactive Iodine, June 2001.
Thyroid Eye Disease. 2003. Decompression surgery in 2009; eyelid lowering surgery in 2010.
Diagnosed: June 2010, liver mets. ER-/PR+10%; HER2+++.
July 2010: Begin Taxol/Herceptin. Eliminate sugar from diet. No surgery or radiation.
January 2011: NED
April 2011: Progression in liver only. Other previous affected areas eradicated. Stop Taxol/Herceptin after 32 infusions.
May 2011: Brain MRI: clear.
May 2011: Begin Tykerb daily, Xeloda twice per day for one week on, one week off, and Herceptin.
November 2011: Progression in liver. All other tumors remain eradicated.
December 2011: BEGIN TRIAL #09-093 Taxol, MCC-DM1 (T-DM1), Perjeta.
Trial requires scans every six weeks, bloodwork and infusions weekly.
Brain MRI: clear.
January 2012: NED. Liver mets, good riddance!
March 2012: NED. Developed SMA (rare blood clot) in intestinal artery and loss of sight in right eye due to optical nerve neuropathy. Resolved when Taxol removed this month.
Continue Protocol of T-DM1 weekly and Perjeta every 3 weeks.
May 2012: NED.
June 2012: Brain MRI: clear.
June-December 2012: NED.
December 2012: TRIAL CONCLUDED; ENTER TRIAL EXTENSION #09-037. CT, Brain MRI, bone scan: clear. NED.
January-March 2013: NED.
June 2013: Brain MRI: clear. CEA upticking; CT shows new met on liver.
July 3, 2013: DISASTER STRIKES during liver ablation: sloppy surgeon cuts intercostal artery and I bleed out, lose 3.5 liters of blood, have major hemothorax, and collapsed lung requiring emergency resuscitative thoracotomy, lung surgery, rib rearrangement and cutting deep connective tissue, transfusion. Ablation incomplete. This life-saving procedure would end up causing me unforgiving pain with every movement I make, permanently, otherwise known as forever.
July 26, 2013: Try Navelbine/Herceptin. Body too weak after surgery and transfusion. Fever. CEA: Normal.
August 16, 2016: second dose Navelbine/Herceptin; CEA: Normal. Will skip doses. Watching and waiting.
September 2013: NED, Herceptin only. CEA: Normal. Started Arimidex.
October-November 2013: NED. Herceptin and Arimidex. CEA, CA125, 15-3: Normal.
December 2013: Something brewing. PET lights up on little spot on liver; CEA upward trend, just outside normal. PET and triphasic liver scan confirm Little Met. Restart Perjeta with Herceptin, stay on Arimidex. Genomic sequencing completed for future treatments, if necessary.
January 2014: Ablate Little Met on the 6th. Happy New Year.
March 2014: Brain MRI: clear. PET/CT reveal liver mets return; new lung mets. This is not funny.
March 2014: BEGIN TRIAL #10-005 A(11)-Temsirolimus plus Neratinib.
April 2014: Genomic testing indicated they could work, they did not. Very strange drug combo for me, felt weird.
April 2014: Started Navelbine and Herceptin. Needed something tried and true, but had significant progression.
June 2014: Doxil and Herceptin.
July 2014: Progression. Got nothing out of it. Brain: NED.
July 2014: Add integrative medical hematologist-oncologist to my team. Begin supplements. These are tumor-busting, immune system boosters. Add glutathione, lysine and taurine IV infusions every three weeks.
July 2014: Begin Gemzar, Herceptin & Perjeta. Happy.
August 2014: ECHO perfect.
January 2015: Begin weekly Vitamin D Analog infusions. 25 mcg. via port.
February 2015: CT: stable.
April 2015: Gem working, but not 100%. Looking into immunotherapy. Finally, treatments for the 21st century!
April 2015: Penn Medicine. Dendritic cell immunotherapy.
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07-06-2012, 06:03 PM
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#10
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Senior Member
Join Date: Aug 2009
Location: Moultrie, GA
Posts: 431
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Re: Genentech's TH3RESA trial has many locations
Mike,
This sounds like a God-send. I pray everything goes well with Barb and the TDM-1 does its job.
Sandra
__________________
Diagnosed: 7/25/08 ~ age 63, no family history
Surgery: 8/14/08 Bilateral mastectomy; tumor left breast, node dissection; right prophylactic with expanders: 1/12/10 latisimuss dorsi flap on left side: 9/22/10 implants in
Pathology Report: ER/PR-; HER2+ (3+); Grade 3, StageIII; 3cm tumor plus 21/21 lymph nodes positive; 5cm DCIS
Chemo: A/C; Taxol/Herceptin/Tykerb; phase II study at Mayo adding Tykerb for early stage
Radiation: 25 rads
Vaccine: Walter Reed GP2/AE37 vaccine study ~ last booster 9/17/2012
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07-21-2012, 10:38 AM
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#11
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Senior Member
Join Date: May 2012
Location: Virginia Beach, VA.
Posts: 38
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Re: Genentech's TH3RESA trial has many locations
The squeaky wheel gets the grease. Keep asking and don't take no for an answer. Best of luck. Keeping Barb & your family in my prayers.
__________________
 Found lump by self-exam 10/14/11
HER2neu +/Estrogen +/progesterone -
Grade III poorly differentiated
R side modified radical mastectomy on 12/09/11 with immediate reconstruction (expander)
Stage IIB 2 nodes + out of 10 removed
Double power port inserted 1/11/12
Chemo therapy (TCH) - every 21 days for 6 cycles beginning 1/25/12
Finished chemo on 5/21/12
Continue Herceptin only every 3 weeks until 12/28/12 Radiation (28 rads) began 6/26/2012.
Will start Femara after radiation ends (8/03/12)
From: It's Not About the Hair:
"The hope for healing is not born out of a fear of death, but a love of life.This is a very good thing. When people love life more than they fear death, they come to treatment with open hands, open hearts, open eyes.When people fear death more than they love life, they are clinging and clutching and grasping."
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