Definition of locally advanced in the indication for IBRANCE?

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Chang1
Chang1 Member Posts: 5
edited July 2018 in Hormonal Therapy - Before, During, and After

Hi,

I was classified when diagnostic as locally advanced breast cancer.

In surgery after neoadjuvant chemotherapy (AC-T) , I had 2 lymph nodes affected with Extracapsular Extension and skin involvement.

I was a candidate for the Pallas trial but I was randomized to the Standard adjuvant endocrine therapy.

I would like to take IBRANCE.


I looked at the indication for IBRANCE (Palbociclib) in "EMA" and in "NICE" "Technology appraisal guidance" and as far as I understand it is indicated for locally advance breast cancer. (Please look at the attached quotes and links below)


My questions:

1. Is IBRANCE indicated for locally advanced breast cancer based on the indication from NICE or EMA?

2. What is the definition of locally advanced in the indication for IBRANCE in NICE or EMA?

3. Is the indication for IBRANCE from NICE and EMA, also valid for locally advanced breast cancer that is amenable to resection or radiation therapy with curative intent?

4. Are you aware of specific countries in the world or other recommendation that will indicate IBRANCE for locally advanced breast cancer that is amenable to resection or radiation therapy with curative intent?


The "Marketing authorisation" from NICE website (Technology appraisal guidance [TA495]):

Palbociclib is indicated for treating 'hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative "locally advanced" or metastatic breast cancer:

in combination with an aromatase inhibitor"


The "Therapeutic indications" from EMA :

"Therapeutic indications

IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative "locally advanced" or metastatic breast cancer:

• - in combination with an aromatase inhibitor;"

Thank you.

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  • beauz
    beauz Member Posts: 207
    edited July 2018

    Hi Chang, there is a thread about Pallas trial in stage III forum here. People there may know more about ibrance.

    I asked my MO about ibrance after my surgery. He said he couldn't prescribe that. But he suggested Xeloda. My diagnosis was locally advanced.


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  • Chang1
    Chang1 Member Posts: 5
    edited July 2018

    Hi beau,

    Thank you I posted the question there.

    I also asked MO about Xeloda (I took AC-T), MO said to me that I can't take Xeloda and hormonal therapy in the same time.

    Did you take Xeloda in the end? (The CREATE-X trail)

    Did you take Xeloda and hormonal therapy in the same time?

    Thanks.

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  • beauz
    beauz Member Posts: 207
    edited July 2018

    I had neoadjuvant chemo(AC+T). My MO looked at trials here that suitable for me, but couldn't find any. I had four rounds of Xeloda after surgery, then radiation therapy, then went back for four more rounds of Xeloda. I have just finished my 5th round tablets. My hormone therapy will come after Xeloda. I am aware that someone is on Xeloda and hormone therapy at the same time (see Xeloda thread in chemo forum).

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