TRIPLE POSITIVE GROUP

Ang, so glad you are ok!  I know you are upset with your daughter, but she is young and stupid, like we all were.  You don't want to hurt her by ending your life.  I had a friend in college who had been rebelling in high school.  She and her Mom were all of their immediate family (no sibs or dad) and she came home one day in her senior year to find her mom had killed herself.  That poor girl was never the same after that.  I lost touch with her after college, but she was just a shell of herself and I doubt she ever got the mind set to do much in her life.  

Keep talking to your mom and to us.  We are here and all of your issues will work out with your daughter.  Remember, she is young and stupid :-)  And she'll be back and you'll get things settled, maybe not right away.  One of my Mom's best friends is so close to her daughter now, and back in the day her daughter was doing heroin and was being arrested for writing bad checks (she used to be a very close friend of mine, but she really lost her way).  She ran off with her boyfriend and they had a daughter and both finally got clean.  Now she and her mom run a bunch of high-end boutiques in the wealthy Philly suburbs and are as close as peas in a pod.  The daughter and her daughter work there too.  Four generations of very strong, loving women!

Vball, you look so dang super cute in your picture!  I love your hair!!

Camille, she posted right about the time you posted - look up above on this page.

Thanks, Jane! I think I will keep it short for a while.

Thursday is my last Herceptin!  I'm so excited.  A friend that I met here sent me the most adorable package - a tiara, a "last one" sign to hang on my IV pole, and a bunch of other really cute items.  Even my hubby cried.

I have now met with four plastic surgeons.  Found one I love in NYC and am waiting for insurance approval since she is out of network. I've pretty much decided to get a prophylactic MX and am looking at a PAP reconstruction.  I need to lose 20 pounds before surgery, so I have my work cut out for me.

Ang...I am just catching up here, but so glad you chose to soldier on. You have had some tough treatments that stressed your body, and now some challenging family issues that stress your mind. Maybe you can think of your treatment as the thing that will give you the time needed to hopefully bring you and your daughter closer.



Moon, I had to look up the PAP also. I believe it is a version of the DIEP surgery.



SpecialK, congrats on three years. I have 4 months to go. And I have to admit that everytime I read something that says recurrence happens most in 5 years, I feel as though I am in the "Danger Zone." Trying to hold out for the three year point to have some testing done .



I burst out laughing when you mentioned that all they asked you was if you had been drinking. I hope you said that you planned to,start as soon as you left the emergency room, lol.



I find it harder to drink now. I order a glass of wine and all that runs through my head is "recurrence" from alcohol. I do still drink socially but some of the fun is gone.

Exciting news released by my company today!

FDA grants Roche’s Perjeta accelerated approval for use before surgery in people with HER2-positive early stage breast cancer

• The Perjeta regimen is the first treatment approved under a new FDA pathway for neoadjuvant use in breast cancer
• This new approval pathway makes Perjeta available to people in the United States with high-risk, early stage breast cancer more quickly than is possible with traditional approvals

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (U.S.) Food and Drug Administration (FDA) granted accelerated approval of a Perjeta (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. This approval is based primarily on data from a Phase II study showing that nearly 40 percent of people receiving the combination of Perjeta, Herceptin (trastuzumab) and docetaxel chemotherapy had no evidence of tumour tissue detectable at the time of surgery (known as a pathological complete response, or pCR). The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the FDA and also the first to be approved based on pCR data.

Neoadjuvant treatment may allow a doctor to quickly assess whether a medicine is working, and may also reduce a tumour's size so it is easier to surgically remove. pCR is a common measure of neoadjuvant treatment effect in breast cancer and can be assessed more quickly than traditional endpoints in early stage breast cancer. Treating people with breast cancer early, before the cancer has spread, may offer the best chance of preventing the disease from returning.

“A new approval pathway has made Perjeta available to people with HER2-positive early breast cancer several years earlier than previously possible,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “Together with the FDA, we’ve charted new territory. We look forward to working with health authorities around the world to explore additional ways to bring promising medicines to patients more quickly.”

This new neoadjuvant indication for Perjeta is for use prior to surgery in combination with Herceptin and docetaxel chemotherapy in people with HER2-positive, locally advanced, inflammatory, or early stage (tumor is greater than two centimeters in diameter or node positive) breast cancer. Perjeta should be used as part of a complete treatment regimen for early stage breast cancer. This use of Perjeta is based on an improvement in the percentage of people who had no evidence of cancer in the breast or lymph nodes at the time of surgery. Currently, no data have shown whether or not treatment with Perjeta prior to surgery improves survival. The safety of Perjeta as part of a doxorubicin (chemotherapy)-containing regimen has not been established. The safety of Perjeta administered for greater than six cycles for early stage breast cancer has not been established.

The Perjeta neoadjuvant indication was granted under the FDA’s accelerated approval programme, which allows conditional approval of a medicine for a life-threatening disease based on early evidence suggesting clinical benefit. The approval is based primarily on results from the NEOSPHERE study, a Phase II study of Perjeta in high-risk, HER2-positive early stage breast cancer. Additional data from the TRYPHAENA study, as well as longer-term safety data from the Phase III CLEOPATRA study of Perjeta in HER2-positive metastatic breast cancer, were also submitted in support of the approval. TRYPHAENA is a Phase II study of Perjeta in HER2-positive early stage breast cancer designed primarily to assess cardiac safety.

A full review of data from the ongoing Phase III APHINITY study will be required for the accelerated approval to be converted to a full approval. APHINITY compares Perjeta, Herceptin and chemotherapy with Herceptin and chemotherapy for adjuvant (post-surgery) treatment of people with HER2-positive early stage breast cancer. Data from APHINITY are expected in 2016.

Roche is discussing the option of submitting Perjeta in the neoadjuvant setting to regulatory authorities in other countries around the world. Perjeta is already approved in a number of countries including the United States for people with HER2-positive metastatic breast cancer (an advanced form of the disease characterised by the spreading of cancer to other parts of the body) or locally recurrent, unresectable (inoperable) breast cancer who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

Perjeta data in HER2-positive early stage breast cancer

NEOSPHERE study

The NEOSPHERE study¹ (Neoadjuvant Study of Pertuzumab and Herceptin in an Early Regimen Evaluation) is a randomised, multicentre, international Phase II study that was conducted in 417 people with newly diagnosed HER2-positive, locally advanced, inflammatory, or early-stage breast cancer. Participants were randomised to four study arms and received four cycles (12 weeks) of neoadjuvant treatment. The primary endpoint was pCR. Secondary endpoints included clinical response, time to clinical response, safety profile, disease-free survival (DFS), breast-conserving surgery rate and biomarker assessment. Study data showed the following:

• Treatment with Perjeta, Herceptin and docetaxel chemotherapy significantly improved the rate of total pCR by 17.8 percent compared to Herceptin and docetaxel alone (39.3 percent vs. 21.5 percent, p=0.0063).
  • pCR of 21.5 percent for Herceptin and docetaxel
  • pCR of 39.3 percent for Perjeta, Herceptin and docetaxel
  • pCR of 11.2 percent for Perjeta and Herceptin
  • pCR of 17.7 percent for Perjeta and docetaxel
• The most common severe (Grade 3 or higher) AEs for the Perjeta regimen were neutropenia (decrease in a certain type of white blood cell, 44.9 percent), febrile neutropenia (fever associated with decrease in a certain type of white blood cell, 8.4 percent), leukopenia (decrease in overall white blood cells, 4.7 percent) and diarrhoea (5.6 percent).

TRYPHAENA Study

The TRYPHAENA study² (ToleRabilitY of Pertuzumab, Herceptin and AnthracyclinEs in NeoAdjuvant breast cancer) is a randomized, multicenter Phase II study that was conducted in 225 people with HER2-positive, locally advanced, inflammatory, or early stage breast cancer with tumors greater than two centimeters. Participants were randomized to one of three neoadjuvant Perjeta regimens. The primary endpoint was cardiac safety. Secondary endpoints included pCR, clinical response, breast-conserving surgery rate, DFS, progression-free survival (PFS), overall survival (OS) and biomarker assessment. Study data showed the following:

• The study was not powered to compare the three study arms. The rates of total pCR in the three arms were as follows:
  • pCR of 56.2 percent for Perjeta, Herceptin and anthracycline-based chemotherapy, followed by Perjeta, Herceptin and docetaxel
  • pCR of 54.7 percent for anthracycline-based chemotherapy, followed by Perjeta, Herceptin and docetaxel
  • pCR of 63.6 percent for the anthracycline-free arm (Perjeta, Herceptin, docetaxel and carboplatin chemotherapy)
• No new or unexpected cardiac AEs, or other AEs, were observed in any of the study arms. AEs observed were consistent with those seen in previous studies of Perjeta, Herceptin and chemotherapy, either in combination or alone.
• The most common severe (Grade 3 or higher) AEs in any of the three study arms were:
  • In the concurrent arm: neutropenia (47.2 percent), leukopenia (decrease in overall white blood cells, 19.4 percent) and febrile neutropenia (18.1 percent)
  • In the sequential arm: neutropenia (42.7 percent), leukopenia (12.0 percent),
  • febrile neutropenia (9.3 percent), diarrhea (5.3 percent) and left ventricular dysfunction (4.0 percent)
  • In the anthracycline-free arm: neutropenia (46.1 percent), febrile neutropenia (17.1 percent), anemia (decrease in red blood cells, 17.1 percent); the AEs of diarrhea, leukopenia, anemia and thrombocytopenia (decrease in platelets) all had an incidence of 11.8 percent

About Perjeta

Perjeta is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Perjeta is designed specifically to prevent the HER2 receptor from pairing (or “dimerising”) with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumour growth and survival. Binding of Perjeta to HER2 may also signal the body’s immune system to destroy the cancer cells. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive blockade of HER signalling pathways.

About breast cancer

Breast cancer is the most common cancer among women worldwide.³ Each year, about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 women will die of the disease annually.³ In HER2-positive breast cancer, increased quantities of the human epidermal growth factor receptor 2 (HER2) are present on the surface of the tumour cells.⁴ This is known as “HER2 positivity” and affects approximately 15-20 percent of women with breast cancer. HER2-positive cancer is a particularly aggressive form of breast cancer.⁵

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Additional information
Roche in Oncology

Wonder if I can ask my doctor to combined it before surgery now with the perjeta if it was approved?

Girlstrong, somehow I can't reply back to your private message. WOW,I thought Perjata won't approved till Oct 31?

Thanks Pbrain. That is awesome news. It does start out October the right way. Just knowing that a lot of people get pCR is so great. Yay! Now for work on stage 4.

Gout, doctors don't read the news much.  Print out our press release and tell him to check FDA's website ;-)

Hi there! I am getting this regimen on Friday October 4th, with some Abraxane for yucks... For the 1st time. It's in Boston and although they have done Abraxane before, the combo of Perjeta, Herceptin and Abraxane is a new one for them...so Im a little nervous, nope, a lot nervous.

Pbrain slam dunk! Sounds very promising and the Dr I saw in Chicago knew it was coming and was very excited about having it an option for early diagnosis as well.

All the best best wishes and comfort to everyone starting this month!!! Bring on the baldino!

Jane, that is awesome news about Perjeta!

Pbrain I think other women are afraid so thats why the avoidance.

I lost my mom unexpectedly a week after my first AC two months ago so I spent a lot of time around relatives .Everyone was fine until I started to lose my hair and look different , it was like I had the plague after that.

Tell your mom its not you its them , sorry they hurt you and your mom .

Hi pbrain, family dynamics are so tricky. I think your on to something when your cousin came to visit and didn't ask once how you were doing (despite seeing you bald!!). The more I go through this the more I realize that a lot of people simply don't know what to say and so stop talking,calling, and visiting. As for the wedding, the fact that your whole family wasn't invited is disturbing. I would hate to think it is because if you. That is simply not a good enough reason. Hopefully your family will find out the real reason soon. Please know that your worth more than a wedding and rely on people who have supported you through this . The others will come back in their own time. Take care.

Thanks guys, I do think it could be one other huge thing, but it has never gotten in the way in the past.  My father had only one sibling, a brother who was the father of these cousins.  He was a great guy when he was younger, but as he got older, he was a total creep.  So growing up with him wasn't easy and the kids went through a lot of emotional abuse.  I am pretty sure my Dad's brother was bipolar.

Meanwhile, my Dad was the sweetest and kindest man who spent time with us and took an interest in things that we did.  He was never heavy handed and honestly was always fair.  He didn't have a temper and we never got in trouble with him (just with Ma).  We all respected him greatly and I know my cousins saw that.  They'd try to find fault with him because they got the raw deal.

But over the years, after my aunt had divorced her husband, we still stayed close to the cousins and to her.  We didn't talk to my uncle.  My Dad had stopped speaking to his brother years ago.  So maybe it is that?  I know Susie was especially hurt by her Dad and she displays some bipolar tendencies and has for awhile.

Or, it is that I am a leper.  ;-)

Cami, I doubt it is the travel.  I head to DC a lot for my job and the cousins know it.  I even was down at the FDA when the immodium wasn't working.  I was pondering over wearing a Depend's sillouette, but I made it through by the grace of God!  ;-)

Aw Pbrain. Its them not you. Dont drive yourself crazy about it. Perhaps they couldnt afford to invite all your family. Well its another idea. I dont think that is it,but im sure it hurts anyway. Their loss.



Oconnor, let us know how the new regimen goes.



Much love to all.

Much love.