Metastatic Breast Cancer News from the 2011 San Antonio Breast Cancer Symposium

Today we'll continue to cover headlines from the 2011 San Antonio Breast Cancer Symposium, with a focus on six studies relevant to women with metastatic breast cancer.

Links may be found on the treatment pages of our LATESTBreastCancer.com website.

Omnitarg for HER2 positive metastatic breast cancer

The phase III Omnitarg (pertuzumab) study, known as CLEOPATRA (CLinical Evaluation Of Pertuzumab and TRAstuzumab), was big news. Reuters, Medical News Today, The New York Times and Los Angeles Times all ran stories. The study was published in the New England Journal of Medicine on December 7. (Link to full text.)

In the study, 808 women with HER2 positive metastatic breast cancer were randomly assigned to receive Herceptin (trastuzumab) and Taxotere (docetaxel) either with or without Omnitarg.

For the Omnitarg group, median progression-free survival, meaning the amount of time the cancer remains stable, was 18.5 months compared to 12.4 months for the Herceptin/Taxotere only group.

Although it's too early to confirm overall survival data, preliminary results show 69 deaths among the 402 women treated with Omnitarg compared to 96 deaths among the 406 women who did not receive Omnitarg.

Genentech and its parent company, Roche, have applied for permission to market Omnitarg in the US and Europe as first-line treatment for HER2 positive metastatic breast cancer.

Avastin for HER2 positive metastatic breast cancer

After the recent FDA decision to pull approval of Avastin for metastatic patients, there has been interest in identifying subsets of patients who may benefit from Avastin.

The phase III study (AVEREL) of Avastin (bevacizumab) in HER2 positive metastatic patients was similar in design to the Omnitarg study. 208 women were treated with Herceptin and Taxotere alone. 216 also received Avastin. The New York Times, Los Angeles Times and US News and World Report/HealthDay covered the study.

For the Avastin group, progression-free survival was 16.5 months, compared to 13.7 months for the 208 in the Herceptin/Taxotere only group.

But some question whether small benefits in progression-free survival are important.

According to the New York Times, "there was absolutely no difference in how long the women lived." Genentech has decided not to apply for FDA approval for HER2 positive breast cancer. A company representative noted, "Our bottom line is we do not believe that the difference in P.F.S. is of a sufficient magnitude that it is likely to gain regulatory approval."

Future research will attempt to identify the subset of patients who benefit from Avastin. As Dr. Gabriel Hortobagyi from MD Anderson noted in Los Angeles Times,

"I have no doubt that Avastin is a very powerful drug for some patients. . . The problem with Avastin is we don’t have a biomarker to help us identify the sub-group."

Afinitor for hormone-receptor positive metastatic breast cancer

A study (BOLERO-2) of Afinitor (everolimus) involving 704 women with hormone-receptor positive breast cancer which progressed on prior hormone therapy was covered by The New York Times, Los Angeles Times and Medical News Today. The study was published in The New England Journal of Medicine on December 7. (Link to full text.)

For women who took Afinitor plus the aromatase inhibitor Aromasin (exemestane), median progression-free survival was 7.4 months, compared to 3.2 months for women who took Aromasin alone.

However, the New York Times (Dec. 7) noted that because all women had already failed to benefit from hormone therapy, "perhaps it is not surprising that the control arm did not do that well on exemestane alone."

But, the trial researchers said that doctors often prescribe Aromasin in practice when other hormone therapies fail.

Medical News Today quoted Dr. Hortobagyi, a study coauthor, to say, "These findings may establish a new standard of care for advanced breast cancer."

Faslodex for hormone-receptor positive metastatic breast cancer

A phase III trial (SWOG S0226) of Faslodex (fulvestrant) plus Arimidex (anastrozole) for women with hormone-receptor positive metastatic breast cancer was covered by the Medical News Today on December 9.

In the study, 707 postmenopausal women were assigned to receive Arimidex plus Faslodex or Arimidex alone. Compared to the Arimidex alone arm, the Faslodex arm experienced longer median overall survival (47.7 months vs. 41.3 months) and longer progression-free survival (15 months vs. 13.5 months).

Both Arimidex and Faslodex are already used to treat breast cancer, though not in comination. The lead study coordinator noted that "these patients have not had a new treatment that gave them an overall survival benefit in more than a decade."

Entinostat for hormone-receptor positive metastatic breast cancer

A small phase II study (ENCORE 301) of entinostat for locally recurrent or metatstatic breast cancer was covered in a PR Newswire press release and the New York Times (Dec. 7)

In the study, 130 patients were treated with Aromasin (exemestane) alone or Aromasin plus entinostat. The median overall survival for the entinostat group was 26.9 months, compared to 19.8 months in the Aromasin alone group. Progression-free survival was also better with entinostat (4.3 months vs. 2.3 months.)

A randomized phase III study is anticipated to begin enrollment in the first half of 2012.

Abraxane as first-line treatment for metastatic breast cancer

A phase II study comparing Abraxane (nab-paclitaxel) to Taxotere (docetaxel) as first-line therapy for metastatic breast cancer was covered by Medical News Today on December 12.

In the study, 300 women who received no prior chemotherapy for metastatic disease were divided into four groups. Three groups received different doses of Abraxane. The fourth group received Taxotere.

The best median overall survival was achieved by the group that received 150 mg of Abraxane twice weekly (33.8 months.) The other two Abraxane dose schedules achieved median overall survival of 22.2 months and 27.7 months. For the Taxotere group, median overall survival was 26.6 months.

Progression-free survival was also better for the Abraxane 150mg/twice weekly group at 14.6 months, compared to 7.5 months and 10.9 months for the other Abraxane doses and 7.8 months for the Taxotere group.


We'll continue to follow research developments for women with metastatic breast cancer. We add links to media stories and journal abstracts to our website, LATESTBreastCancer.com everyday. The latest news and research may be explored anytime by clicking the Treatments tab.

Media Headlines from the 2011 Breast Cancer Symposium

Breast Cancer Symposium 2011 is underway in San Francisco this week. Today we'll share the media coverage of some of the presentations.

Medical News Today: "Young Women With Early Breast Cancer Have Similar Survival With Breast Conservation, Mastectomy"

More young women under 40 with breast cancer are choosing mastectomy over breast conserving surgery (lumpectomy), in part because of concerns about recurrence. Two presentations suggest that there is no survival difference between women treated with a mastectomy and those treated with a lumpectomy plus radiation.

US News and World Report wrote about both studies. The first, presented a few days ahead of the Symposium, evaluated medical records of 628 women aged 21 to 40. Local recurrence and survival rates were similar for women treated with mastectomy and women treated with lumpectomy.

According to Medical News Today, the second study reviewed the records of nearly 15,000 women under 40 with breast cancer. Overall survival was similar between women treated with mastectomy and those treated with lumpectomy plus radiation. When women were matched with others with similar cancer characteristics, such as tumor size and lymph node involvement, there was no difference in overall survival.

HemOnc Today: "New tool may help predict breast-cancer-associated lymphedema"

On September 8, HemOnc Today shared a Brazilian study of a model to predict lymphedema before axillary lymph node dissection. The statistical model "demonstrated more than 70% accuracy for predicting the 5-year risk for developing lymphedema after lymph node removal during breast cancer surgery."

Dr. Jose Bevilacqua, a study author, noted that the model used "readily available clinical factors," such as age, BMI and number of chemotherapy cycles, for a "quick and easy estimation of individual risks of developing lymphedema after axillary lymph node surgery in women with breast cancer."

Drugs.com: "Syndax Pharmaceutical's Positive Phase 2 Data Supports Potential for Entinostat in Advanced Breast Cancer"

On September 6, Drugs.com printed a press release from Syndax about a positive phase 2 study of entinostat for advanced breast cancer.

For post-menopausal women with estrogen-receptor positive metastatic breast cancer, entinostat plus Aromasin (exemestane) improved progression-free survival and overall survival compared to placebo plus Aromasin.

A phase 3 trial is planned for early 2012.

US News and World Report: "Annual Breast Exams, Mammograms Still Key to Detecting Breast Cancer"

There's more fuel in the screening mammography debate. On September 6, US News and World Report/HealthDay covered a study from Michigan which reviewed breast cancer detection and treatment records from almost 6,000 women with breast cancer.

Overall, breast cancer detected by palpitation (feel) tended to be later-stage and more likely to be treated with a mastectomy and chemotherapy compared to breast cancer detected by mammography.

For women under 50, 48% of breast cancers were detected by mammography and 46% by palpitation. Dr. Andrew Seidman, an official of the American Society of Clinical Oncology (ASCO), said, "Undoubtedly, this area will continue to remain an area of controversy for some, but certainly women in this age group would be well-served to know about this data."


Not every study we add to the LATESTBreastCancer.com website and database makes media headlines. Next week, we'll highlight some new research which is under the media radar. Please stay tuned.

The Breast Cancer News Update: June 2

Today in breast cancer news, there is advice relating to hormone replacement therapy after ovary removal, progress for two treatments for advanced disease and two lab discoveries which may lead to new treatments for triple-negative breast cancer.

Hormone replacement therapy is safe for BRCA mutation carriers after ovary removal

Researchers from the University of Pennsylvania recommend that women with BRCA1/2 gene mutations have prophylactic oophorectomies (surgical ovary removal) after childbearing to decrease cancer risk. Some women resist this option due to concerns about menopausal symptoms after surgery. According to a recent study, short-term hormone replacement therapy after oophorectomy for menopausal symptom relief does not increase breast cancer risk for young patients.

Progress in the development of tesetaxel and etinostat for advanced breast cancer

Early results of a study of tesataxel as first-line therapy for recurrent or metastatic breast cancer are promising. To date, 60 percent of the patients in the study have attained an average 55% reduction in tumor size. Tesetaxel, an oral taxane, "has been generally well tolerated," with "no substantial neuropathy or alopecia (hair loss)." Tesetaxel has been previously studied as second-line therapy with a 38% response rate. An expert panel will be convened to explore registration strategies for the drug.

A US patent has been issued for etinostat in combination with aromatase inhibitors for metastatic breast cancer. According to a statement from the company, entinostat is expected to extend the benefit of hormone therapy and delay the start of chemotherapy. Phase III studies are planned.

Lab discoveries may lead to new treatments for triple-negative or basal breast cancer

Researchers from the Dana-Farber Cancer Institute have identified a network of growth-spurring genes called the Jak2/Stat3 pathway, which drives triple-negative breast tumors. In animal studies, drugs to block the pathway halted tumor growth. Jak2/Stat3 inhibitor drugs are already in advanced clinical trials for other cancers. It "should be possible to begin testing them in breast cancer patients soon."

Australian researchers have discovered a "hedgehog" molecule, with a "spiky structure" responsible for the spread of basal breast cancer. In animal studies, blocking the molecule results in smaller tumors which don't spread as far. Readily available "hedgehog" blocking drugs have been studied in other cancers. Researchers are hopeful that they will be effective in tests on breast cancer patients.

Please check back tomorrow as we highlight the research abstracts added to the LATESTBreastCancer.com database this week.