TKI1258, BKM120, trial studies for metastatic breast cancer

There are two studies currently looking for participants. If you are a woman with metastatic breast cancer, and your oncologist hasn’t mentioned the studies to you, bring it up with them. I know the studies are being done nationwide right now (fall 2013). I was expected to begin pre-trial base-line markers this month, but I am not in the studies, after all. More in next blog about that, but I wanted to get this information out to those interested.

One study, TKI1258 (TKI) is a multi-center, randomized, double-blind, placebo controlled, phase II trial. It’s being evaluated for the safety and efficacy of TKI in combination with fulvestrant – also known as Faslodex (a shot). The trial will be of post-menopausal women with Her2, and HR+ breast cancer that have evidence of disease progression on or after [one] prior endocrine therapy.

The other trial study, BKM120, is a phase III randomized, double-blind placebo controlled study with BKM120 with fulvestrant. The participants will be post-menopausal women with hormone receptor positive or Her2-negative, locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment.

There is expected to be 150 TKI and 1,060 BKM participants in the multi-center studies in the USA. Both studies are by the pharmaceutical company Novartis. The hospital where I go was looking for five patients for each study. If you’re interested in the study, look into it. It may take them a while to find matches.

Talk with your oncologist. Good luck!


Win a “Pink Time Out” Getaway!


Photo Courtesy: Jean Campbell

If  you know Jean Campbell, you know her work with No Boobs About it, and Pink Time Out. She’s a special lady who gives so much time and effort to women  transitioning from breast cancer treatment to “Life after breast cancer.”

No Boobs About it has its second “Pink Time Out” coming up this December.

Christmas in New York City will be a 3-day NYC getaway for a woman who has

recently completed active treatment for breast cancer and a companion. The

getaway will include a stay at a luxury hotel in mid-Manhattan, tickets to

Radio City Holiday Show, breakfasts, and dinners at elegant restaurants.

This “Pink Time Out” getaway is being sponsored by my former students at

the Allen School for Health Sciences, Brooklyn, NY. Please read all about

it at

The Christmas in NYC recipient will be chosen through a lottery drawing.

The lottery will be open for enrollment October 1st and close October

31st. The lottery drawing will be on November 1. Any woman who has

completed, or will complete active treatment between October 1, 2012 and

October 31, 2013 may enroll in the lottery. For more information, visit

Why a “Pink Time Out”? It’s about getting away from all things breast

cancer, putting closure on months of active treatment, and easing the

transition to life in survivorship!

Ductal Carcinoma in situ (DCIS)

Shown is a drawing of a breast duct containing...

Shown is a drawing of a breast duct containing ductal carcinoma in situ. (Photo credit: Wikipedia)

Ductal Carcinoma in situ (DCIS) is an atypical proliferation of cells in the breast duct. It’s not a breast tumor, and it’s not invasive cancer. There are two ways to look at this: It is pre-invasive. It is non-invasive. So, it is pre-cancer?

I came across an article “Figuring out what DCIS diagnosis really means”, by Sue Rochman, MAMM Oct, 2000. The little I knew about DCIS, I presumed DCIS was pre-spread of cancer, and considered cancer. The one thing I am very clear on now is that there is lots of debate about DCIS.

What is agreed upon is that DCIS doesn’t have the same capabilities as a tumor. It doesn’t have the molecular genetics to invade and metastasize. Women with DCIS won’t necessarily progress to invasive cancer—however, in an overwhelming majority, women with invasive cancer also have DCIS.

If it could be determined what causes DCIS to potentially become invasive, then doctors could figure out what women require treatment, and what women don’t. Since that isn’t happening yet, all women with DCIS are treated. The question I have had for years, “How much is too much treatment?”

The shift in the last twenty years has been from seeing DCIS as a single disease and if left untreated was likely to invade, to seeing DCIS as having a risk of progressing, and invading, depending on other factors. There’s a spectrum within the DCIS diagnosis. The DCIS shift has also moved from mastectomy to lumpectomy, followed by radiation, and sometimes an anti-estrogen therapy (such as Tamoxifen) for hormone receptor breast cancer. Some women opt for a mastectomy over a lumpectomy. Some to avoid radiation, others require a mastectomy when the area in concern is too large for a lumpectomy in order to preserve the breast’s appearance.

Barbara Brenner, the then executive director or The San Francisco based advocacy group Breast Cancer Action, spoke about, “What’s too much treatment?” She said, “It’s clear that some women who get surgery and being over treated for DCIS. The problem is we don’t have any method to distinguish those who need treatment from those who don’t. I don’t think any doctor could safely tell a patient that she shouldn’t be treated for DCIS. But the net result is that we are doing way more surgeries and a lot more radiation than is probably necessary.”

Dr. Silverstein of USC, adamantly argued that some women are being over treated. “Low grade DCIS doesn’t come at you like a bull and not stop. There’s plenty of time to deal with this, and the majority of it never becomes invasive breast cancer. I believe that you can pick out patients who are not going to benefit from radiation therapy. And that’s what the debate is all about.”

Progress has been made. Now, DCIS is technically classified as a cancer. The cells are just like invasive cancer—except they  haven’t spread beyond the ducts of the breast. Can you imagine having surgery—a lumpectomy or mastectomy, having radiation, and taking medication—and not having statistics kept, or being considered as having cancer? Now DCIS patients do fit into the category of cancer, which I hope helps them through the process of support, gathering information, and receiving the right treatment, or non-treatment to fit their needs best.

Related Posts: DCIS To Treat or Not to Treat

Gene Markers for Cancer Risk

Main sites of metastases for some common cance...

Main sites of metastases for some common cancer types. Primary cancers are denoted by “…cancer” and their main metastasis sites are denoted by “…metastases”. List of included entries and references is found on main image page in Commons: (Photo credit: Wikipedia

In an article from March 2013, the Associated Press, Internationally, there are more than 100 institutions and 200,000 people taking part in genetic testing. Through this collaboration, dozens of signposts for disease in DNA have been found. The primary risks studied have been for breast, ovarian, and prostate cancer.

What does it mean for the average person?

There are genetic tests now, for instance, testing for BRCA gene mutation. If a woman tests positive, she has a higher risk for breast or ovarian cancer. These mega-collaborative studies may mean that one day there will be genetic tests that help identify a woman who has the most to gain from having a mammogram, and men who’d benefit most from PSA tests, and prostate biopsies. And, those tests may lead to genetic hints of new treatments.

The thinking behind these studies is if a person has a 20 percent risk of a certain type of cancer in their lifetime, genetic markers could identify those at higher risk, say 60 percent, or people who exceed 80 percent from those whose risk is 20-50 percent. The difference this could bring may mean someone choses to monitor their lower risk rather than opt for surgery as a preventative method (such as women having healthy breasts removed.)

The three markers found reveal hints about the biology of these cancers, and the hope is these underpinnings will pay off as better therapies the future. As studies go, this is encouraging, but more research is needed to see how helpful this would be in guiding a patient.

Pink Time Outs Program


Some of you may know Jean Campbell. She’s behind the blog No Boobs About It. She’s got a passion about spreading the word, and helping others -women and men- who’ve experienced breast cancer. Her latest accomplishment is Pink Time Outs Program.

The Pink Time Outs Program provides women and men, who have recently finished active treatment (surgery, chemo, radiation) for breast cancer, with funded short getaways from all things breast cancer.

The Pink Time Outs© Program is about using short getaways to put closure on the end of active treatment and facilitate the transition to life as a survivor. The goals of this program are simple:

  • A physical and mental break from all talk, sights and routines that remind us of breast cancer
  •  The opportunity to feel refreshed in mind, body and spirit
  • To enjoy a much-needed time out to recreate and participate in normalizing activities
  • The freedom to think about something other than breast cancer, to begin thinking about what comes next as a survivor.

The first Pink Time Outs© funded getaway is April 2, 2013 at the Biltmore Estates in Ashville, North Carolina. To see the details of the trip, please go to

The winner and companion will be chosen by lottery drawing. The Biltmore Estates getaway is the first of many getaways planned in the months to come across the U.S. and Canada. Individuals who qualify for this lottery event can take part and be the winner of a much needed get away.

If you or someone you know is interested in this fabulous treat, go check out her blog listed above. Good luck! Enjoy – and Thanks!

Breast Cancer Classification

Just this weekend I received this from a relative:

Breast cancer classification promises better therapies

In hopes to more precisely target treatments and bypass unnecessarily toxic therapies, researchers have devised 10 categories for breast cancer tumors.

The article is by Eryn Brown, Los Angeles Times. April 19 2012

The complete article can be viewed at:,0,7505697.story

Warning Signs of Lymphedema

Lymphedema is a serious, progressive condition. Stage-1 lymphedema can be reversed. Pay attention to your body. Early diagnosis and treatment are essential. The following are warning signs of lymphedema. If you are an individual who is at risk for lymphedema, become familiar with the list below and contact your doctor, or lymphedema therapist if you notice any of the changes.

  •  Feeling of heaviness, or pressure in the affected limb.
  • Sensation of swelling – even before swelling takes place.
  • Jewelry or clothing fitting more snugly than usual.
  • “Pins and needles” feeling in the affected limb.
  • Bursting sensation in the limb.
  • Skin not bouncing back after pressure is applied to the swollen part and held for a moment.
  • Loss of skin elasticity.
  • Hardening of the skin.
  • Skin ulcerations.
  • Red or blotchy skin – it could be a sign of a very serious bacterial infection.
  • Feeling of heat in the affected limb, or quadrant of body.
  • Even before a visual sign is present, sensing a difference, could be the first sign of onset.