Potential New Adjuvant Tx for Stage II-III

Hello Ladies!  I don't know if this has been discussed here already, but I thought this was news that ER+/HER2- Stage III ladies might like to be aware of.

Palbociclib Enters Adjuvant Testing for Stage II-III Breast Cancer

The article also includes a video with a doctor explaining more about the clinical trial and their hope for the drug.

For those who may not know, Palbociclib is a CDK4/6 Inhibitor which means it plays a role in stopping cancer cells from progressing to the proliferative phase.  It is not a chemo or hormonal treatment.  Based on previous and current clinical trials in the Metastatic BC setting, Palbociclib has been shown to prevent existing tumors from any further growth and in many cases causes regression of tumors.  It more than doubles survival time in Stage IV, yet survival stats are still not complete because so many women in the Stage IV trials are still living.

As some of you know, I have been dealing with BC for over 14 years now.  Was NED in Stage IIIC for over 8 years before becoming Stage IV this past March.  I was fortunate to enroll in the Pfizer Palbociclib clinical trial in April.  My only Stage IV tx to date has been the trial protocol.  My mets spread was determined to be to lymph nodes in neck, chest and abdomen.  The trial is specifically tracking 3 of my largest nodes in the abdominal area.  After the first 2 months of treatment my scans showed a 33% reduction in the size of those 3 nodes.  At the end of 4 months I have a total of 39% reduction of those nodes, plus no new lesions or areas of concern.

Pfizer has already applied for early FDA approval of Palbociclib which possibly will become publicly available in 2015.  If the Dana Farber trial and others show positive results in their Stage II-III trials, this may become another adjuvant treatment option for Stage II-III women.

Here is the link to the actual Dana Farber trial info in Boston, in case any ladies are in that area.  The trial indicates it is still recruiting.  There is a detailed listing of inclusion and exclusion criteria. 

http://www.cancer.gov/clinicaltrials/search/view?cdrid=757030&version=patient

Linda

P.S.   I want to clarify that the clinical trial I am in is a double blind study, so neither I nor my research staff know for a certainty that I am getting the Palbociclib active drug instead of Placebo.  I am for sure getting the Faslodex injections as standard of care, just as everyone else in the trial is getting.  SO...it is possible that the good response I have experienced so far is due solely to Faslodex.  Based on my current understanding of the anticipated SE's on Palbociclib, however, my educated guess is that I am on the active trial drug. My personal experience is anecdotal at best, the real data is in the final analysis of data from the completed trials. So it is always best to evaluate based on the scientific data.  I just happen to have a personal opinion about my experience which may or may not be accurate.

Life is not measured by how many breaths we take...but by the
moments that take our breath away! ...I am a 14/8 yr survivor of 2
Primary BCs, 23/23 Positive Nodes (Zometa x 5 years) Started Paloma-3
Clinical Trial 4-14-14

Dx 7/14/2000, IDC, 1cm, Stage IIa, Grade 1, 2/7 nodes, ER+/PR+, HER2-

Dx 11/21/2005, ILC, 5cm, Stage IIIc, Grade 1, 23/23 nodes, ER+/PR-, HER2-

Dx 3/21/2014, ILC, Stage IV, mets, ER+/PR-, HER2-

Surgery 08/11/2000 Lumpectomy (Right); Lymph Node Removal: Sentinel Lymph Node Dissection (Right)

Chemotherapy 08/30/2000 Adriamycin, Cytoxan, Taxol

Radiation Therapy 02/26/2001 External

Hormonal Therapy 05/10/2001 Tamoxifen

Surgery 12/05/2005 Mastectomy (Both); Lymph Node Removal: Axillary Lymph Node Dissection (Left)

Chemotherapy 12/23/2005 Taxotere, Xeloda

Radiation Therapy 04/07/2006 External

Hormonal Therapy 04/07/2006 Aromasin

Hormonal Therapy 04/14/2014 Faslodex