HER2 Support Group Forums - View Single Post - Need ammunition for TCH

ExpectAMiracle · 03-29-2007, 05:14 PM

Thanks to everyone for all of this information. I have printed all of the articles for review with my onc. I went to the Genentech website to look for the FDA approval info on Herceptin and it says that the approval was for node positive cancer
:
<TABLE cellSpacing=0 cellPadding=3 width=514 border=0><TBODY><TR vAlign=top bgColor=#eeeeee><TD>November 2006 </TD><TD><TABLE cellSpacing=0 cellPadding=2 width=386 border=0><TBODY><TR vAlign=top><TD width=8>

</TD><TD width=378>The Food and Drug Administration (FDA) approves Herceptin as part of a treatment regimen containing doxorubicin, cyclophosphamide and paclitaxel, for the adjuvant treatment of patients with HER2-positive, node-positive breast cancer.</TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE>
This is all so confusing. I also found the following at the Genetech site:

The company also submitted in the fourth quarter of 2006 a supplemental Biologics License Application (sBLA) for the use of Herceptin® (Trastuzumab) in node-negative patients with administration once every three weeks, based on the one-year adjuvant HERA (HERceptin Adjuvant) trial conducted internationally by Roche and the Breast International Group (BIG).

Does anyone know if this has been approved yet? I guess not if Genentech doesn't say it at their site? If the FDA approved the use, I think my insurance would have to go along.

So many of the articles say "early stage" breast cancer, but they don't say "node negative". Isn't stage II still considered early stage?

I appreciate all of your help and will share it all with my onc! Keep it coming if there is any more info.

Hugs!

Susan

03-29-2007, 05:14 PM	#8
ExpectAMiracle Senior Member Join Date: Mar 2007 Location: SW Virginia Posts: 50	Thanks to everyone for all of this information. I have printed all of the articles for review with my onc. I went to the Genentech website to look for the FDA approval info on Herceptin and it says that the approval was for node positive cancer : <TABLE cellSpacing=0 cellPadding=3 width=514 border=0><TBODY><TR vAlign=top bgColor=#eeeeee><TD>November 2006 </TD><TD><TABLE cellSpacing=0 cellPadding=2 width=386 border=0><TBODY><TR vAlign=top><TD width=8></TD><TD width=378>The Food and Drug Administration (FDA) approves Herceptin as part of a treatment regimen containing doxorubicin, cyclophosphamide and paclitaxel, for the adjuvant treatment of patients with HER2-positive, node-positive breast cancer.</TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE> This is all so confusing. I also found the following at the Genetech site: The company also submitted in the fourth quarter of 2006 a supplemental Biologics License Application (sBLA) for the use of Herceptin® (Trastuzumab) in node-negative patients with administration once every three weeks, based on the one-year adjuvant HERA (HERceptin Adjuvant) trial conducted internationally by Roche and the Breast International Group (BIG). Does anyone know if this has been approved yet? I guess not if Genentech doesn't say it at their site? If the FDA approved the use, I think my insurance would have to go along. So many of the articles say "early stage" breast cancer, but they don't say "node negative". Isn't stage II still considered early stage? I appreciate all of your help and will share it all with my onc! Keep it coming if there is any more info. Hugs! Susan __________________ Susan in VA Determined to be a VICTOR not VICTIM - by the grace of God! DX 2/8/07 at 48 1.75 cm IDC in left breast, Stage 1 Grade 3, ER-/PR-/HER 3+ Lumpectomy 3/7/07, 5/5 nodes clear, clear margins Starting TCH on 4/9/07, every 3 weeks X 4 treatments - Completed on 6/12/2007 33 rads to began 7/2/07 and completed on 8/22/07 Herceptin every 3 weeks until April '08